Baird Medical (Nasdaq: BDMD) details warrant share registration and major resale
Baird Medical Investment Holdings Limited has filed a prospectus to register up to 11,500,000 ordinary shares issuable upon exercise of public warrants at US$11.50 per share, plus up to 34,415,562 ordinary shares for resale by existing shareholders, including Betters Medical shareholders, the SPAC sponsor, Cohen, Grand Fortune Capital and its Hong Kong affiliate.
The company will not receive proceeds from resale of these 34,415,562 shares and expects limited cash from warrant exercises because its Nasdaq share price of US$1.63 on December 4, 2025 was well below the US$11.50 exercise price. The filing notes that, assuming warrant exercise and preferred share conversion, these resale shares represent about 70.9% of shares outstanding, and large sales could pressure the stock price. Baird Medical operates through PRC subsidiaries, highlights significant regulatory and capital-flow risks tied to China, and warns that HFCAA-related auditor inspection issues could eventually lead to a Nasdaq delisting, which could cause the ordinary shares’ value to decline substantially.
Positive
- None.
Negative
- None.
Insights
Large registered resale overhang and China/HFCAA risks create notable structural headwinds.
The prospectus registers two main blocks: up to
Management quantifies that, assuming all warrants are exercised and GFC preferred shares convert, the 34,415,562 resale shares equal approximately
Beyond the capital-structure overhang, the company operates entirely through PRC subsidiaries and details extensive China-related risks, including capital controls, dividend constraints, and evolving CSRC filing and data-security regimes. It further notes that an inability of the PCAOB to fully inspect auditors in China, combined with HFCAA rules, could ultimately lead to a U.S. trading prohibition and Nasdaq delisting if certain conditions are met, which it acknowledges could cause the ordinary shares to significantly decline in value.
UP TO 34,415,562 ORDINARY SHARES OFFERED BY SELLING SECURITYHOLDERS
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Page
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ABOUT THIS PROSPECTUS
|
| | | | ii | | |
|
FINANCIAL STATEMENT PRESENTATION
|
| | | | iii | | |
|
INDUSTRY AND MARKET DATA
|
| | | | iv | | |
|
FREQUENTLY USED TERMS
|
| | | | v | | |
|
FORWARD-LOOKING STATEMENTS
|
| | | | ix | | |
|
SUMMARY OF THE PROSPECTUS
|
| | | | 1 | | |
|
THE OFFERING
|
| | | | 10 | | |
|
RISK FACTORS
|
| | | | 12 | | |
|
CAPITALIZATION
|
| | | | 60 | | |
|
SELECTED HISTORICAL FINANCIAL DATA
|
| | | | 61 | | |
|
USE OF PROCEEDS
|
| | | | 64 | | |
|
DIVIDEND POLICY
|
| | | | 65 | | |
|
CORPORATE HISTORY AND STRUCTURE
|
| | | | 66 | | |
|
ENFORCEABILITY OF CIVIL LIABILITIES AND AGENT FOR SERVICE OF PROCESS IN
THE UNITED STATES |
| | | | 70 | | |
|
BUSINESS
|
| | | | 72 | | |
|
GOVERNMENT REGULATIONS
|
| | | | 120 | | |
|
MANAGEMENT’S DISCUSSION AND FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
| | | | 142 | | |
|
MANAGEMENT
|
| | | | 159 | | |
|
BENEFICIAL OWNERSHIP OF SECURITIES
|
| | | | 166 | | |
|
SELLING SECURITYHOLDERS
|
| | | | 168 | | |
|
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS
|
| | | | 175 | | |
|
DESCRIPTION OF OUR SECURITIES
|
| | | | 178 | | |
|
SHARES ELIGIBLE FOR FUTURE SALE
|
| | | | 198 | | |
|
TAXATION
|
| | | | 199 | | |
|
PLAN OF DISTRIBUTION
|
| | | | 209 | | |
|
EXPENSES RELATED TO THE OFFERING
|
| | | | 212 | | |
|
LEGAL MATTERS
|
| | | | 213 | | |
|
EXPERTS
|
| | | | 214 | | |
|
WHERE YOU CAN FIND MORE INFORMATION
|
| | | | 215 | | |
|
INDEX TO FINANCIAL STATEMENTS
|
| | | | F-1 | | |
outstanding
|
As of June 30, 2025
|
| |
On an actual basis
|
| |||
| | | |
(in US$)
|
| |||
|
Cash and cash equivalents
|
| | | | 2,171,492 | | |
| Debt: | | | |||||
|
Non-current financial borrowings
|
| | | | 5,898,630 | | |
|
Current financial borrowings
|
| | | | 35,467,781 | | |
|
Total Debt
|
| | | | 41,366,411 | | |
| Equity: | | | | | | | |
|
Preferred shares
|
| | | | 29 | | |
|
Ordinary shares
|
| | | | 2,655 | | |
|
Statutory reserve
|
| | | | 4,611,287 | | |
|
Additional paid in capital
|
| | | | 17,770,394 | | |
|
Retained earnings
|
| | | | 15,450,720 | | |
|
Accumulated other comprehensive loss
|
| | | | (2,247,122) | | |
|
Total shareholder’s equity
|
| | | | 35,587,963 | | |
|
Non-controlling interests
|
| | | | 36,108 | | |
|
Total Capitalization
|
| | | | 76,990,482 | | |
| | | |
Year Ended December 31,
|
| |
For the six months ended June 30,
|
| ||||||||||||||||||||||||
| | | |
2022
|
| |
2023
|
| |
2024
|
| |
2024
|
| |
2025
|
| |||||||||||||||
| | | |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |||||||||||||||
|
Revenues
|
| | | $ | 35,091,174 | | | | | $ | 31,457,908 | | | | | $ | 37,037,108 | | | | | $ | 13,136,588 | | | | | $ | 7,959,494 | | |
|
Cost of revenues
|
| | | | (7,054,323) | | | | | | (4,227,409) | | | | | | (4,383,363) | | | | | | (1,645,559) | | | | | | (1,424,240) | | |
|
Gross profit
|
| | | | 28,036,851 | | | | | | 27,230,499 | | | | | | 32,653,745 | | | | | | 11,491,029 | | | | | | 6,535,254 | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Selling and marketing expenses
|
| | | | (3,585,138) | | | | | | (2,547,000) | | | | | | (4,061,116) | | | | | | (1,168,576) | | | | | | (1,127,725) | | |
|
General and administrative expenses
|
| | | | (6,960,604) | | | | | | (8,546,880) | | | | | | (7,103,226) | | | | | | (3,205,845) | | | | | | (8,677,640) | | |
|
Research and development expenses
|
| | | | (3,859,392) | | | | | | (4,274,894) | | | | | | (6,174,365) | | | | | | (2,027,439) | | | | | | (7,180,293) | | |
|
Total operating expenses
|
| | | | (14,405,134) | | | | | | (15,368,774) | | | | | | (17,338,707) | | | | | | (6,401,860) | | | | | | 16,985,658 | | |
|
Income from operations
|
| | | | 13,631,717 | | | | | | 11,861,725 | | | | | | 15,315,038 | | | | | | 5,089,169 | | | | | | (10,450,404) | | |
|
Interest expense
|
| | | | (299,269) | | | | | | (285,833) | | | | | | (576,752) | | | | | | (238,919) | | | | | | (358,215) | | |
|
Interest income
|
| | | | 8,553 | | | | | | 1,562 | | | | | | 393 | | | | | | 264 | | | | | | 762 | | |
|
Subsidy income
|
| | | | 1,375,447 | | | | | | 791,959 | | | | | | 266 | | | | | | 265 | | | | | | 56,968 | | |
|
Other expenses, net
|
| | | | (194,580) | | | | | | (10,211) | | | | | | (651,657) | | | | | | 5,627 | | | | | | (49,107) | | |
|
Income before income tax
|
| | | | 14,521,868 | | | | | | 12,359,202 | | | | | | 14,087,288 | | | | | | 4,856,406 | | | | | | (10,799,996) | | |
|
Income tax provision
|
| | | | (1,746,897) | | | | | | (1,701,019) | | | | | | (1,489,190) | | | | | | (481,279) | | | | | | (559,131) | | |
|
Net income
|
| | | $ | 12,774,971 | | | | | $ | 10,658,183 | | | | | $ | 12,598,098 | | | | | $ | 4,375,127 | | | | | $ | (11,359,127) | | |
| Other comprehensive loss, net of tax | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Foreign currency translation adjustment
|
| | | $ | (1,506,905) | | | | | $ | (728,688) | | | | | $ | (1,135,939) | | | | | $ | (828,730) | | | | | $ | 893,939 | | |
|
Comprehensive income
|
| | | $ | 11,268,066 | | | | | $ | 9,929,495 | | | | | $ | 11,462,159 | | | | | $ | 3,546,397 | | | | | $ | (10,465,188) | | |
|
Net income attributable to controlling
shareholders |
| | | $ | 12,568,750 | | | | | $ | 10,545,978 | | | | | $ | 12,453,369 | | | | | $ | 3,501,537 | | | | | $ | (10,399,956) | | |
|
Basic earnings per common share
|
| | | | 0.49 | | | | | | 0.41 | | | | | | 0.49 | | | | | | 0.17 | | | | | | (0.43) | | |
|
Diluted earnings per common share
|
| | | | 0.49 | | | | | | 0.41 | | | | | | 0.49 | | | | | | 0.17 | | | | | | (0.43) | | |
| | | |
As of December 31,
|
| |
As of
|
| ||||||||||||
| | | |
2023
|
| |
2024
|
| |
June 30, 2025
|
| |||||||||
| ASSETS | | | | | | | | | | | | | | | |||||
| CURRENT ASSETS | | | | | | | | | | | | | | | |||||
|
Cash
|
| | | $ | 1,510,484 | | | | | $ | 2,970,199 | | | | | $ | 2,171,492 | | |
|
Accounts receivable, net
|
| | | | 31,099,891 | | | | | | 46,575,776 | | | | | | 40,824,995 | | |
|
Inventories
|
| | | | 1,142,569 | | | | | | 1,296,577 | | | | | | 1,430,376 | | |
|
Prepayments, net
|
| | | | 5,814,691 | | | | | | 10,274,207 | | | | | | 15,983,806 | | |
|
Deposits and other assets, net
|
| | | | 120,485 | | | | | | 295,754 | | | | | | 332,689 | | |
|
Due from related parties
|
| | | | 394,582 | | | | | | 2,862 | | | | | | 2,916 | | |
|
Total Current Assets
|
| | | | 40,082,702 | | | | | | 61,415,375 | | | | | | 60,746,274 | | |
| NON-CURRENT ASSETS | | | | | | | | | | | | | | | | | | | |
|
Property and equipment, net
|
| | | | 6,138,694 | | | | | | 7,141,064 | | | | | | 6,705,182 | | |
|
Intangible assets, net
|
| | | | 25,479 | | | | | | 16,528 | | | | | | 12,631 | | |
|
Deferred tax assets
|
| | | | 814,372 | | | | | | 714,461 | | | | | | 700,524 | | |
|
Right-of-use assets
|
| | | | 861,331 | | | | | | 475,119 | | | | | | 289,395 | | |
|
Deferred offering costs
|
| | | | 875,258 | | | | | | — | | | | | | — | | |
|
Goodwill
|
| | | | 59,375 | | | | | | 57,772 | | | | | | 58,869 | | |
|
Prepayments – non current
|
| | | | 7,698,728 | | | | | | 8,021,046 | | | | | | 8,353,796 | | |
|
Deposits and other assets – non current
|
| | | | 152,450 | | | | | | 121,505 | | | | | | 123,811 | | |
|
Total Non-Current Assets
|
| | | | 16,625,687 | | | | | | 16,547,495 | | | | | | 16,244,208 | | |
|
Total Assets
|
| | | $ | 56,708,389 | | | | | $ | 77,962,870 | | | | | $ | 76,990,482 | | |
| CURRENT LIABILITIES | | | | | | | | | | | | | | | | | | | |
|
Short-term bank loans
|
| | | | 8,166,400 | | | | | | 16,166,000 | | | | | | 13,953,020 | | |
|
Tax payables
|
| | | | 770,953 | | | | | | 2,873,453 | | | | | | 2,452,315 | | |
|
Salaries and benefits payable
|
| | | | 750,635 | | | | | | 797,912 | | | | | | 693,309 | | |
|
Contract liability
|
| | | | 499,905 | | | | | | 792,102 | | | | | | 1,093,434 | | |
|
Short-term lease liabilities
|
| | | | 503,891 | | | | | | 264,316 | | | | | | 118,607 | | |
|
Accounts payable
|
| | | | 550,188 | | | | | | 1,252,667 | | | | | | 2,136,075 | | |
|
Amounts due to a related party
|
| | | | 3,785,250 | | | | | | 3,703,700 | | | | | | 4,502,547 | | |
|
Accrued listing expenses payable
|
| | | | 2,172,651 | | | | | | 5,341,848 | | | | | | 5,282,105 | | |
|
Accrued expenses and other payables
|
| | | | 864,687 | | | | | | 2,518,175 | | | | | | 2,623,151 | | |
|
Deferred tax liabilities
|
| | | | 93,389 | | | | | | 45,238 | | | | | | 21,559 | | |
|
Long-term loan – current portion
|
| | | | 817,485 | | | | | | 867,772 | | | | | | 2,591,659 | | |
|
Total Current Liabilities
|
| | | | 18,975,434 | | | | | | 34,623,183 | | | | | | 35,467,781 | | |
| NON-CURRENT LIABILITIES | | | | | | | | | | | | | | | | | | | |
|
Long-term lease liabilities
|
| | | | 412,121 | | | | | | 136,683 | | | | | | 84,459 | | |
|
Long-term loan – non current
|
| | | | 1,613,579 | | | | | | 3,442,526 | | | | | | 5,814,171 | | |
|
Total Non-Current Liabilities
|
| | | | 2,025,700 | | | | | | 3,579,209 | | | | | | 5,898,630 | | |
|
Total Liabilities
|
| | | $ | 21,001,134 | | | | | $ | 38,202,392 | | | | | $ | 41,366,411 | | |
| | | |
As of December 31,
|
| |
As of
|
| ||||||||||||
| | | |
2023
|
| |
2024
|
| |
June 30, 2025
|
| |||||||||
| Equity | | | | | | | | | | | | | | | | | | | |
|
Preferred shares, $0.0001 par value; 5,000,000 shares authorized; 290,000 shares issued and outstanding as of December 31, 2024 and June 30, 2025
|
| | | | — | | | | | | 29 | | | | | | 29 | | |
|
Ordinary shares, $0.0001 par value; 500,000,000 shares authorized; 35,728,625 shares issued, 25,555,096 shares outstanding as of December 31, 2024; 40,979,382 shares issued, 26,552,370 shares outstanding as of June 30, 2025*
|
| | | | 2,556 | | | | | | 2,556 | | | | | | 2,655 | | |
|
Additional paid-in capital*
|
| | | | 18,850,677 | | | | | | 11,441,712 | | | | | | 17,770,394 | | |
|
Statutory reserve
|
| | | | 4,508,366 | | | | | | 4,591,151 | | | | | | 4,611,287 | | |
|
Retained earnings
|
| | | | 14,394,167 | | | | | | 26,764,751 | | | | | | 15,450,720 | | |
|
Accumulated other comprehensive loss
|
| | | | (2,005,122) | | | | | | (3,141,061) | | | | | | (2,247,122) | | |
|
Total Baird Medical Investment Holdings Limited’s Shareholders’ Equity
|
| | | | 35,750,644 | | | | | | 39,659,138 | | | | | | 35,587,963 | | |
|
Non-controlling interests
|
| | | | (43,389) | | | | | | 101,340 | | | | | | 36,108 | | |
|
Total Liabilities and Equity
|
| | | $ | 56,708,389 | | | | | $ | 77,962,870 | | | | | $ | 76,990,482 | | |
| | |||||||||||||||||||
| | | |
For the year ended December 31,
|
| |
For the six months
ended June 30, |
| ||||||||||||||||||||||||
| | | |
2022
|
| |
2023
|
| |
2024
|
| |
2024
|
| |
2025
|
| |||||||||||||||
| | | |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |||||||||||||||
|
Net cash (used in)/generated from operating activities
|
| | | $ | 485,968 | | | | | $ | (1,019,964) | | | | | $ | (6,313,115) | | | | | $ | (3,960,397) | | | | | $ | (3,194,035) | | |
|
Net cash used in investing activities
|
| | | | (5,921,464) | | | | | | (2,638,488) | | | | | | (2,853,678) | | | | | | (484,839) | | | | | | (44,610) | | |
|
Net cash generated from financing activities
|
| | | | 4,411,918 | | | | | | 3,461,118 | | | | | | 10,720,781 | | | | | | 4,457,217 | | | | | | 2,195,443 | | |
|
Effect of exchange rate changes on cash and restricted cash
|
| | | | (297,647) | | | | | | (3,108) | | | | | | (94,273) | | | | | | (20,051) | | | | | | 244,495 | | |
|
Net (decrease)/increase in cash and restricted cash
|
| | | | (1,321,225) | | | | | | (200,442) | | | | | | 1,459,715 | | | | | | (8,070) | | | | | | (798,707) | | |
|
Cash and restricted cash at beginning of the year/period
|
| | | | 3,032,151 | | | | | | 1,710,926 | | | | | | 1,510,484 | | | | | | 1,510,484 | | | | | | 2,970,199 | | |
|
Cash and restricted cash at end of the
year/period |
| | | $ | 1,710,926 | | | | | $ | 1,510,484 | | | | | $ | 2,970,199 | | | | | $ | 1,502,414 | | | | | $ | 2,171,492 | | |
|
Registered Name
|
| |
Registration
Certificate Number |
| |
Class
|
| |
Model
|
| |
Product Characteristics Classification
|
| |
Useful
Life Span |
| |||
| Disposable Water-Cooled Microwave Thermal Coagulation Ablation Needle | | |
NMPA
20183011581 |
| |
Class III
|
| |
XR-A2021W, XR-A2018W, XR-A2015W, XR-A2021R (round head), XR-A2018R (round head)
|
| | Long Microwave Ablation Needles | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
2. Microwave frequency: 2450 MHz;
3. Specifications: needle length is 15 cm to 21 cm, needle diameter is 2.0 mm, to meet various clinical needs;
4. Scope of application: used for the treatment of liver tumors (solid tumor therapy is limited to patients with a diameter ≤3cm and fewer than 3 lesions of metastatic liver cancer).
|
| | 2 years | |
| Disposable Water-Cooled Microwave Thermal Coagulation Ablation Needle | | |
NMPA
20183011581 |
| |
Class III
|
| |
XR-A1610W
|
| | Fine Microwave Ablation Needle | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
2. Microwave frequency: 2450 MHz;
3. Specifications: needle length is 10 cm, needle diameter is 1.6 mm;
4. Scope of application: used for the treatment of benign thyroid nodules (nodule diameter ≥2cm, solid >80%, progressive enlargement, symptoms of compression, and aesthetic impact).
|
| | 2 years | |
|
Registered Name
|
| |
Registration
Certificate Number |
| |
Class
|
| |
Model
|
| |
Product Characteristics Classification
|
| |
Useful
Life Span |
| |||
| Disposable Microwave Ablation Needle | | |
NMPA
20233010963 |
| |
Class III
|
| |
J-20-15,
J-20-12, J-20-10, J-20-08, J-20-05, J-18-15, J-18-12, J-18-10, J-18-08, J-18-05 |
| | Long Microwave Ablation Needles | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
2. Microwave frequency: 2450 MHz;
3. Specifications: needle length is 5 cm to 15 cm, needle diameter is 1.8mm to 2.0 mm, to meet various clinical needs;
4. Scope of application: used for the treatment of benign thyroid nodules (nodule diameter ≥2cm, solid >80%, progressive enlargement, symptoms of compression, and aesthetic impact).
|
| | 2 years | |
| Disposable Microwave Ablation Needle | | |
NMPA
20233010963 |
| |
Class III
|
| |
J-16-15, J-16-12, J-16-10, J-16-08, J-16-05, J-14-15, J-14-12, J-14-10, J-14-08, J-14-05
|
| | Fine Microwave Ablation Needle | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
2. Microwave frequency: 2450 MHz;
3. Specifications: needle length is 5 cm to 15 cm, needle diameter is 1.4mm to 1.6mm, to meet various clinical needs;
4. Scope of application: used for the treatment of benign thyroid nodules (nodule diameter ≥2cm, solid >80%, progressive enlargement, symptoms of compression, and aesthetic impact).
|
| | 2 years | |
|
Registered Name
|
| |
Registration
Certificate Number |
| |
Certificate validity
|
| |
Class
|
| |
Model
|
| |
Product Characteristics Classification
|
| |
Service Life
|
| |||
| Disposable Microwave Ablation Needle | | |
NMPA 20233011839
(国械注准20233011839) |
| | December 4, 2023 to December 3, 2028 | | | Class III | | |
G-16-20,
G-16-15, G-16-10, G-16-08 |
| | Fine Microwave Ablation Needles | | |
This product is used in medical institutions, together with our microwave therapeutic apparatus (models: MTI-5AT, MTI-5ET and MTI-5DT) for the treatment of primary liver cancer with a diameter of ≤3cm or metastatic liver cancer with a diameter of ≤3cm and less than 3 lesions.
|
| | 2 years | |
|
Registered Name
|
| |
Registration
Certificate Number |
| |
Certificate validity
|
| |
Class
|
| |
Model
|
| |
Product Characteristics Classification
|
| |
Service Life
|
| |||
| | | | | | | | | | | | |
G-20-25,
G-20-21, G-20-18, G-20-15, G-18-25, G-18-21, G-18-18, G-18-15, |
| | Long Microwave Ablation Needles | | | | | | | |
|
Disposable Microwave Ablation Needle
|
| |
NMPA 20243010517
(国械注准20243010517) |
| |
March 19, 2024 to March 18, 2029
|
| | Class III | | |
J-16-12-XT,
J-16-10-XT, J-16-08-XT, J-16-05-XT, J-14-15-XT, J-14-12-XT, J-14-10-XT, J-14-08-XT, J-14-05-XT |
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Fine Microwave Ablation Needles
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This product is used in medical institutions, together with our microwave therapeutic apparatus (models: MTI-5AT, MTI-5ET, and MTI-5DT) for the treatment of benign thyroid nodules (with a nodule diameter ≥2cm, solid content >80%, progressive enlargement, presence of compression symptoms, and affecting appearance of patient)
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| | 2 years | |
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J-20-15-XT,
J-20-12-XT, J-20-10-XT, J-20-08-XT, J-20-05-XT, J-18-15-XT, J-18-12-XT, J-18-10-XT, J-18-08-XT, J-18-05-XT, J-16-15-XT, |
| | Long Microwave Ablation Needles | | | | | | | |
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Product
Category |
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Classification
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Size
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Frequency
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Power
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Power
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Useful Life
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Special Features
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Picture
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MTI-5AT
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Class III
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490mm×460mm
×155mm |
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2,450 MHz
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range of 0 to 120W, with 1W interval
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magnetron
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eight years
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touch-screen, over-heating protection, portable
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MTI-5B
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Class III
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445mm×330mm
×156mm |
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2,450 MHz
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range of 0 to 120W, with 1W interval
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magnetron
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eight years
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physical buttons, applicable to radiation therapy, portable
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Product
Category |
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Classification
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Size
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Frequency
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Power
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Power
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Useful Life
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Special Features
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Picture
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MTI-5C
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Class III
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430mm×520mm
×950mm |
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2,450 MHz
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range of 0 to 120W, with 1W interval
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magnetron
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eight years
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touch-screen, applicable to radiation therapy, movable
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MTI-5DT
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Class III
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580mm×750mm
×1450mm |
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2,450 MHz
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range of 0 to 120W, with 1W interval
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magnetron
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eight years
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touch-screen, over-heating protection, two-port output for treatments using two microwave ablation needles simultaneously, movable
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MTI-5ET
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Class III
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490mm×460mm
×155mm |
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2,450 MHz
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range of 0 to 120W, with 1W interval
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solid state source
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eight years
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touch-screen, over-heating protection, portable
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Model
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Registration Certificate
Number |
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Certificate
Validity |
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Class
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Frequency
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Power
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Power Source
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Service Life
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| MTI-5AT | | |
NMPA 20183011581
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6 Feb. 2023 to 5 Feb, 2028
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Class III
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2,450MHz
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Range 0 to 120W,
1W interval |
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Magnetron
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8 years
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| MTI-5B | | |
NMPA 20183011581
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6 Feb. 2023 to 5 Feb, 2028
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Class III
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2,450MHz
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Range 0 to 120W,
1W interval |
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Magnetron
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8 years
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| MTI-5C | | |
NMPA 20183011581
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6 Feb. 2023 to 5 Feb, 2028
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Class III
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2,450MHz
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Range 0 to 120W,
1W interval |
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Magnetron
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8 years
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| MTI-5DT | | |
NMPA 20183011581
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6 Feb. 2023 to 5 Feb, 2028
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Class III
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2,450MHz
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Range 0 to 120W,
1W interval |
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Magnetron
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8 years
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| MTI-5ET | | |
NMPA 20183011581
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6 Feb. 2023 to 5 Feb, 2028
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Class III
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2,450MHz
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Range 0 to 120W,
1W interval |
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Solid-state
source |
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8 years
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Registered Name
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Registration Certificate
Number |
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Certificate
Validity |
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Class
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Model
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Product Characteristics Classification
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Service
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Disposable Water-Cooled Microwave Thermal Coagulation Ablation Needle
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NMPA 20183011581
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6 Feb. 2023 to
5 Feb. 2028 |
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Class III
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XR-A2021W,
XR-A2018W, XR-A2015W, XR-A2021R (round head), XR-A2018R (round head) |
| | Long Microwave Ablation Needles | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
2. Microwave frequency: 2450 MHz;
3. Specifications: needle length is 15 cm to 21 cm, needle diameter is 2.0 mm, to meet various clinical needs;
4. Scope of application: used for the treatment of liver tumors (solid tumor therapy is limited to patients with a diameter ≤3cm and fewer than 3 lesions of metastatic liver cancer).
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2 years
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XR-A1610W
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| | Fine Microwave Ablation Needle | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
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| Disposable Microwave Ablation Needle | | |
NMPA 20233010963
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13 Jul. 2023-
12 Jul. 2028 |
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Class III
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J-20-15, J-20-12, J-20-10, J-20-08, J-20-05, J-18-15, J-18-12, J-18-10, J-18-08, J-18-05
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| | Long Microwave Ablation Needles | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
2. Microwave frequency: 2450 MHz;
3. Specifications: needle length is 5 cm to 15 cm, needle diameter is 1.8mm to 2.0 mm, to meet various clinical needs;
4. Scope of application: used for the treatment of benign thyroid nodules (nodule diameter ≥2cm, solid >80%, progressive enlargement, symptoms of compression, and aesthetic impact).
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2 years
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J-16-15, J-16-12, J-16-10, J-16-08, J-16-05, J-14-15, J-14-12, J-14-10, J-14-08, J-14-05
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| | Fine Microwave Ablation Needle | | |
1. Needle material: the needle tip is tin-phosphor bronze, the needle shaft is stainless steel, with PTFE coating;
2. Microwave frequency: 2450 MHz;
3. Specifications: needle length is 5 cm to 15 cm, needle diameter is 1.4mm to 1.6mm, to meet various clinical needs;
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Registered Name
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Registration Certificate
Number |
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Certificate
Validity |
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Class
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Model
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Product Characteristics Classification
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Service
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4. Scope of application: used for the treatment of benign thyroid nodules (nodule diameter ≥2cm, solid >80%, progressive enlargement, symptoms of compression, and aesthetic impact).
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Registered Name
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Registration Certificate
Number |
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Certificate Validity
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Class
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Model
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Service Life
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| Disposable Sterile Biopsy Needle | | |
SXZZ 20232141234
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30 Aug. 2023 to
19 Aug. 2028 |
| | Class II | | | BN-MAR-1 | | | 2 years | |
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical
Study Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrolment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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Jiangxi Provincial Cancer Hospital
Zhuhai People’s Hospital
Lishui People’s Hospital
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Associate Chief Physician from such hospital
Associate Chief Physician from such hospital
Chief Physician from such hospital
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To determine the rate of complete ablation of thyroid nodules of Nanjing Changcheng’s MWA ablator and the single-use MWA ablation needles and whether such products were inferior compared to the designated control medical product.
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A prospective, multicenter, randomized, open, positive control, non-inferiority test design was adopted, and a total of 132 cases were enrolled, including 66 cases in each of the experimental group and the control group. Treatment with microwave ablation or radiofrequency ablation was randomized among the subjects who agreed to be enrolled. By recording the relevant examinations at baseline, 1 month after treatment, 3 months after treatment, and 6 months after treatment, comparing data such as the proportion of subjects with successful surgery, nodule shrinkage, occurrence of complications, and the proportion
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VRSO1 radiofrequency ablation treatment system host (Registration number: NMPA 20173252338) and electrode needles (Registration Number: NMPA 20143255486) manufactured by STARmed Co., Ltd.
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Primary endpoint: ablation nodule volume reduction rate at six months after operation;
Secondary endpoint: Surgical success rate, postoperative nodule volume reduction rate (30-days, 90-days, and 180-days post operation), ultrasound blood flow score, thyroid function tests;
Baseline evaluation index: vital signs, incidence of treatment-related complications, incidence of other adverse events, evaluation of system operation safety;
Safety evaluation index: vital signs, incidence of treatment-related complications, incidence of other adverse events, evaluation of system operation safety;
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Enrolment Criteria:
1. Age between 18 to 70 years old (inclusive), no gender limit;
2. Subjects whose target nodules were confirmed to be benign lesions by fine needle aspiration cytology (FNAC) or pathological biopsy within six months prior to surgery, or whose TI-RADS classification by color Doppler examination was classified as category 1~3;
3. Nodule diameter ≥2cm, or the proportion of solid portion of the nodule is greater than 80%, and no other treatment (e.g., surgical treatment, radioactive iodine treatment, TSH suppression treatment, percutaneous anhydrous ethanol injection, etc.) has been
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132 subjects were enrolled in total. Out of the 132 subjects, 52 were enrolled in the hospital in the Jiangxi province, 48 were enrolled in the hospital in the Guangdong province, and 32 subjects were enrolled in the hospital in the Zhejiang province, respectively, with each hospital allocating half of their enrolled subjects to the test group and control group, respectively.
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Based on a review of past clinical studies, the average reduction rate in nodule volume after 6 months of the standard treatment is about 80%. Given the study is designed to compare the new treatment (the test group) against the control treatment which is already available on the market (the control group), we have proceeded with the non-inferiority margin rate of -15%, meaning in this study, the new treatment can be up to 15% less effective than the control treatment and still be considered statistically to perform just as well in comparison to the control treatment. Further, this trial proceeded with the estimate that: (i) conservatively, there may be a 28% deviation difference between patients in the test group and control group; and (ii) there is a 2.5% chance of a false positive in determining non-inferiority
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A total of 15 adverse events were recorded, where 8 adverse events may relate to the trial, with the remaining 7 being unrelated and concern the deteriorating medical conditions of the enrolled subject. None such events involved a device defect that could lead to adverse events occurred during the trial.
Related Adverse Event: Out of the 8 adverse events, 4 post-operative subjects reported hoarseness of their voice, 2 post-operative subjects reported neck pain, 1 post-operative subject complained of neck inflammation and 1 post-operative subject complained of sore throat. Such adverse
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| | Completed. | |
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical
Study Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrolment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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of patients with effective treatments, to evaluate the safety and effectiveness of the trial product for thermal ablation treatment of benign thyroid nodules.
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Evaluation of Product Use: common functions, ease of use, reliability evaluation.
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performed;
4. The presence of subjective symptoms that are obviously related to the nodule (e.g., foreign body sensation, neck discomfort or pain, or symptoms caused by adjacent organs); or an tendency of malignant transformation (e.g., the occurrence of related symptoms, or imaging tests suggesting that the size of the nodule is increasing progressively); or patients with excessive worries that affect normal life; or subjects with symptoms of hyperthyroidism caused by autonomous functional nodules;
5. Subjects (or their designated agents) must sign the informed consent form.
Exclusion Criteria:
1. Subjects with abnormal vocal cord function on
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and an 80% chance of correctly concluding the new treatment to perform just as well in comparison to the control treatment.
Based on inputting these assumptions into a statistical software called PASS11, it was determined that 56 subjects needed to be enrolled in each of the test group and the control group, for an aggregate of 112 participants. However, because we expect that about 15% of the participants may drop out of the study throughout the trial or fail to follow-up with the researchers, we planned to enroll at least 132 participants to ensure that we will have sufficient sample data for this trial even with potential patient drop-outs.
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events are common complications caused by ablation treatment.
Unrelated Adverse Event: The 7 adverse events unrelated to the trial involved subjects which were diagnosed with various conditions, such as gastric polyp, microinvasive adenocarcinoma of the lung, or an adenoma of the sigmoid colon. These subjects were subsequently hospitalized and were either treated or symptoms alleviated such that the clinical trial may continue.
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical
Study Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrolment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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the contralateral side of the lesion;
2. Subjects with active thyroiditis and infections at the surgical site or adjacent sites;
3. Subjects with large areas of calcification in the nodule that affect observation;
4. Subjects with large blood vessels and nerves around the thyroid nodules, serious adhesion of the nodules to the esophagus and trachea, etc., and nodules located at the lower pole of the gland and beyond the sternum;
5. Subjects with severe heart, liver, or kidney dysfunction (cardiac function grade II and above; ALT, AST > 2.5 times the upper limit of normal value; serum creatinine > 1.5 times the upper limit of normal value);
6. Severe anemia
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical
Study Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrolment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
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Status
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(Hb<60g/L);
7. Subjects with cognitive abnormalities or severe mental illness, etc., who are unable to cooperate with the study;
8. Pregnant and lactating women;
9. Subjects who have participated in other clinical studies within the past three months;
10. Other conditions in which the researcher believes that the patient is not suitable to participate in this study.
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical Study
Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrollment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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Sun Yat-sen University Cancer Center
the Fifth Affiliated Hospital of Guangzhou Medical University Shandong Provincial Qianfoshan Hospital the Affiliated Hospital of Putian University |
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Chief Physician from such Hospital
Chief Physician from such hospital
Chief Physician from such hospital
Chief Physician from such hospital
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To evaluate the rate of complete ablation of breast lump nodules of the MWA ablator and its accompanying ablation needles produced by Nanjing Changcheng and whether such products were inferior compared to the designated control medical product.
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The clinical trial is designed as “prospective, multicenter, stratified group randomized, open, parallel positive control, and non-inferiority test”. to verify that when the microwave ablation device and supporting ablation needle produced by Nanjing Changcheng Medical Equipment Co., Ltd. are used for ablation of breast fibroadenoma, the complete nodule ablation rate is not inferior to that of the control product, which meets the requirements of clinical application, and the product is safe and reliable in the process of use. A total of 188 cases will be enrolled.
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WE7568-II tumor ablation treatment system generator (Registration number: NMPA 20173014200) and the WHK-1A, WHK-1B, WHK-1C, WHK-2A, WHK-2B and WHK-2C models of ablation electrode needles registered by Beijing Wei’erfu Electronics Company.
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Primary endpoint: complete nodule ablation rate on postoperative day 90±7;
Secondary endpoint:
1. nodule volume reduction rates on day 90 ± 7, day 180 ± 14, and day 360 ± 14;
2. evaluation of the ablation device’s operational performance;
3. evaluation of the ablation needle’s operational performance;
4. visual analog scale pain scores;
5. aesthetic satisfaction.
Safety evaluation indexes: SAE (serious adverse event) incidence rate, AE (adverse event) incidence rate, and device defect incidence rate.
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Enrollment Criteria:
(1) Age between 18 to 50 years old (inclusive), no gender limit;
(2) Breast solid nodule with a longitudinal diameter ranging from 10mm to 30mm (inclusive), as measured by ultrasound;
(3) Target breast nodules, within the 3 months prior to ablation, confirmed as fibroadenomas through hollow needle (large needle) biopsy;
(4) Subjects or their legal representative can understand the purpose of the study, demonstrate adequate compliance with the study protocol, and sign the informed consent form.
Exclusion Criteria:
(1) Subjects who have received treatment prior to target breast nodule ablation or
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| | N/A | | |
Based on a review of the literature2 and considering the clinical practice, it is expected that both the new treatment (the test group) and the control treatment which is already available on the market (the control group) will completely eliminate the breast lump in 95% of cases. On this basis, we have proceeded with the non-inferiority margin rate of -10%, meaning in this study, the new treatment can be up to 10% less effective than the control treatment and still be considered statistically to perform just as well in comparison to the control treatment. Further, this trial proceeded with the estimate that there is a 2.5% chance of a false positive in determining non-inferiority and an 80% chance of correctly concluding the
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| | N/A | | |
The clinical test stage has not yet carried out.
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical Study
Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrollment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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who require treatment by other methods (e.g., surgery, focused ultrasound ablation, cryoablation, or ethanol injection) during the trial;
(2) Subjects with severe bleeding tendency and obvious hemogram abnormalities that cannot be corrected within a short period of time for coagulation dysfunction (platelets < 50× 109/L, prothrombin time > 25s);
(3) Subjects whose anticoagulant therapy and/or antiplatelet drugs have not been discontinued for more than 7 days prior to treatment;
(4) Subjects with abnormal function of heart, lung, liver, kidney and other important organs (cardiac function NYHA grade 3 or above, ALT, AST > 1.5 times the upper limit of normal reference value, or Ccr < 60ml/min);
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new treatment to perform just as well in comparison to the control treatment.
Based on these assumptions and parameters, we calculated that at least 75 participants in each of the test group and the control group (or 150 participants in total) would be needed. However, we expect that about 20% of participants may drop out or fail to follow-up with the researchers throughout the trial, and therefore in order to accumulate sufficient data for this research, we have determined a total of 188 subjects will be required to be enrolled, such that there are 94 participants in each of the test group and the control group.
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical Study
Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrollment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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(5) Subjects with other serious medical conditions (including clinically relevant cardiovascular disease or myocardial infarction within 12 months prior to enrollment; history of severe neurological or psychiatric disorders; preoperative presence of serious infections that must be controlled with medications; active disseminated intravascular coagulation; and high thrombotic risk);
(6) Subjects with ineffective control of blood sugar (fasting blood sugar > 7 mmol/L or glycosylated hemoglobin > 7% during the screening period);
(7) Subjects with built-in breast prosthesis;
(8) Subjects with implanted pacemakers or cardiac electrodes;
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| | | | | | | | | | | | | | | | | | | (9) Pregnant and lactating women; | | | | | | ||||||||
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical Study
Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrollment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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(10) Subjects who have participated in a clinical trial of another drug or device within 3 months prior to the trial;
(11) Subjects who, in the opinion of the researcher, are not suitable for participation in this clinical trial.
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical Study
Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrollment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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Sun Yat-sen
University Cancer Center Beijing Hospital Beijing Chao-Yang Hospital of the Capital Medical University Qingdao Central Hospital |
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Chief Physician of such hospital
Chief Physician of such hospital
Chief Physician of such hospital
Associate Chief Physician such hospital
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To evaluate the rate of complete ablation of breast lump nodules of the MWA ablator and its accompanying ablation needles produced by Nanjing Changcheng and whether such products were inferior compared to the designated control medical product.
|
| |
The clinical trial is designed as “prospective, multicenter, stratified group randomized, open, parallel positive control, and non-inferiority test” to verify that when the microwave ablation instrument and disposable microwave ablation needle produced by Nanjing Changcheng Medical Equipment Co., Ltd. are used for pulmonary nodule ablation, the complete ablation rate of pulmonary
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| |
WE7568-II tumor ablation treatment system generator (Registration number: NMPA 20173014200) and the WHK-1A, WHK-1B, WHK-1C, WHK-2A, WHK-2B and WHK-2C models of ablation electrode needles registered by Beijing Wei’erfu Electronics Company.
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Primary endpoint: complete ablation rate of pulmonary nodules on postoperative day 90±7 and postoperative day 180±14;
Secondary endpoint:
1. immediate ablation effectiveness rate 48 hours after pulmonary nodule ablation;
2. evaluation of the ablation device’s operational performance;
3. evaluation of the ablation needle’s operational performance.
Safety
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Enrollment criteria
(1) Age between 18 to 75 years old (inclusive), no gender limit;
(2) Subjects who plan to undergo ablation treatment of malignant or suspected malignant pulmonary nodules, including alveolar epithelial atypical adenomatoid hyperplasia or primary peripheral non-small cell lung cancer or pulmonary nodules with malignant tendency;
(3) Subjects
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| | N/A | | |
Based on a review of the literature3 and considering the clinical practice, it is expected that both the new treatment (the test group) and the control treatment which is already available on the market (the control group) will completely eliminate the pulmonary nodule 180 days after the treatment in 96% of cases. On this basis, we have proceeded with the non-inferiority margin rate of -10%, meaning in
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| | N/A | | |
The clinical test stage has not yet carried out.
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Institution
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Principal
Researcher |
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Research
Objective |
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Clinical Study
Design |
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Designated
Control Medical Product |
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Evaluation
Index |
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Enrollment
and Exclusion Criteria |
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Subject
Enrolment Breakdown |
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Sample Size
Calculation |
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Adverse
Events |
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Status
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|
| | | | | | | | | |
nodules is non-inferior to that of the control product, which meets the requirements of the clinical application, and the products are safe and reliable in the process of use. A total of 152 cases will be enrolled.
|
| | | | |
evaluation indexes: SAE (serious adverse event) incidence rate, AE (adverse event) incidence rate, device defect incidence rate.
|
| |
with no more than 3 unilateral pulmonary nodules (bilateral lungs ≤5) and with lung nodules requiring ablation that are 8 mm to 30 mm in diameter (inclusive);
(4) The subject refuses or is deemed unsuitable for surgical resection or stereotactic radiation therapy;
(5) Subjects or their legal representative can understand the purpose of the study, demonstrate adequate compliance with the study protocol, and sign the informed consent form.
Exclusion Criteria:
(1) Subjects with Eastern Cooperative Oncology Group performance status score >3;
(2) Subjects who have received chemotherapy, radiation therapy, immunotherapy, targeted therapy, surgery, or other minimally invasive
|
| | | | |
this study, the new treatment can be up to 10% less effective than the control treatment and still be considered statistically to perform just as well in comparison to the control treatment. Further, this trial proceeded with the estimate that there is a 2.5% chance of a false positive in determining non-inferiority and an 80% chance of correctly concluding the new treatment to perform just as well in comparison to the control treatment.
Based on these assumptions and parameters, we calculated that at least 61 participants in each of the test group and the control group (or a total of 122 participants) would be necessary. However, we expect that about 20% of participants may drop out or fail to follow-up with the researchers throughout the trial, and therefore in order to accumulate sufficient data for this trial,
|
| | | | | | |
|
Institution
|
| |
Principal
Researcher |
| |
Research
Objective |
| |
Clinical Study
Design |
| |
Designated
Control Medical Product |
| |
Evaluation
Index |
| |
Enrollment
and Exclusion Criteria |
| |
Subject
Enrolment Breakdown |
| |
Sample Size
Calculation |
| |
Adverse
Events |
| |
Status
|
|
| | | | | | | | | | | | | | | | | | |
approaches to tumor treatment within 30 days prior to ablation;
(3) Subjects who require continued treatment of the tumor or pulmonary nodule with chemotherapy, radiotherapy, immunotherapy, targeted therapy, surgery, or other minimally invasive methods for the duration of the trial after surgery;
(4) Subjects with severe pulmonary fibrosis and pulmonary hypertension;
(5) Subjects requiring ongoing hormone therapy throughout the trial period;
(6) Subjects with pleural effusion and poor control;
(7) Subjects with impaired consciousness or unable to cooperate with treatment;
(8) Subjects with severe bleeding tendency and obvious hemogram abnormalities that cannot be corrected within a short period of time
|
| | | | |
we have determined a total of 152 subjects will be required to be enrolled, such that there are 76 participants in each of the test group and the control group.
|
| | | | | | |
|
Institution
|
| |
Principal
Researcher |
| |
Research
Objective |
| |
Clinical Study
Design |
| |
Designated
Control Medical Product |
| |
Evaluation
Index |
| |
Enrollment
and Exclusion Criteria |
| |
Subject
Enrolment Breakdown |
| |
Sample Size
Calculation |
| |
Adverse
Events |
| |
Status
|
|
| | | | | | | | | | | | | | | | | | |
for coagulation dysfunction (platelets<50×109/L, prothrombin time >18s, and prothrombin activity <40%);
(9) Subjects whose anticoagulant therapy and/or antiplatelet drugs have not been discontinued for more than 7 days prior to treatment, and the interval between the last use of bevacizumab did not exceed 1 month;
(10) Subjects with significant organ insufficiency or other serious diseases (including cardiovascular disease affecting the treatment of this ablation surgery or myocardial infarction within 12 months prior to enrollment; history of severe neurological or psychiatric illness; active disseminated intravascular coagulation; high thrombotic risk; severe anemia, dehydration, and severe disturbances in nutritional
|
| | | | | | | | | | | | |
|
Institution
|
| |
Principal
Researcher |
| |
Research
Objective |
| |
Clinical Study
Design |
| |
Designated
Control Medical Product |
| |
Evaluation
Index |
| |
Enrollment
and Exclusion Criteria |
| |
Subject
Enrolment Breakdown |
| |
Sample Size
Calculation |
| |
Adverse
Events |
| |
Status
|
|
| | | | | | | | | | | | | | | | | | |
metabolism that cannot be corrected or improved in the short term; severe systemic infections, and hyperthermia (>38.5°C);
(11) Fasting blood glucose >8 mmol/L at any time before surgery;
(12) Combination of other tumors with extensive metastases;
(13) Subjects with implanted cardiac pacemakers that cannot be discontinued during treatment;
(14) Pregnant and lactating women;
(15) Subjects who, in the opinion of the researcher, are not suitable for participation in this clinical trial.
|
| | | | | | | | | | | | |
|
Product Category
|
| |
NMPA
Classification |
| |
Features
|
| |
Development
Stage |
| |
Expected
Launch Date |
| |
Target
Indication |
|
| Microwave ablation ultrasound integrated therapeutic apparatus | | | Class III | | |
Equipped with built-in ultrasound scanner for locating the tumor precisely during treatment
Reflects real-time data of therapeutic apparatus on the ultrasound machine interface, allowing doctors to manage data easily and focus on observing the patient during the treatment
To be used in conjunction with different proprietary microwave ablation needles for the treatment of different diseases
|
| | Product Design | | | Fourth quarter of 2025 | | | Thyroid nodules, liver tumors | |
| MTI-5GT four-source microwave ablation therapeutic apparatus | | | Class III | | |
Output frequency of 2,450 MHz
Four-port outputs for treatment utilizing four needles simultaneously
Each output is equipped with an independent temperature sensor allowing real-time reflection of temperature data
Applicable to microwave ablation treatment of large tumors
To be used in conjunction with different proprietary microwave ablation needles for the treatment of different diseases
|
| | Clinical trial preparation | | | Fourth quarter of 2025 | | | Bone tumors | |
| Microwave Ablation Therapy Device and Disposable Microwave Ablation Needle | | | Class III | | |
Suitable for microwave ablation treatment of large tumors. Using solid-state power supply as the microwave emission source, no-load status can be detected to ensure the safety of clinical use
Equipped with LED display and user-friendly interface
Used with different proprietary microwave ablation needles to treat different conditions
|
| | Clinical trial preparation | | | Fourth quarter of 2025 | | | uterine fibroids | |
|
Product Category
|
| |
NMPA
Classification |
| |
Features
|
| |
Development
Stage |
| |
Expected
Launch Date |
| |
Target
Indication |
|
| MTI-5FT therapeutic apparatus | | | Class III | | |
Output frequency of 915 MHz which has stronger penetration power
Applicable to microwave ablation treatment of large tumors. Uses solid-state power as the source of microwave emission, which can detect no-load condition and ensure safe clinical use
Equipped with LED display with user- friendly interface
To be used in conjunction with different proprietary microwave ablation needles for the treatment of different diseases
|
| | Clinical trial preparation | | | Fourth quarter of 2024 | | | Thyroid nodules, liver tumors | |
|
Product Category
|
| |
NMPA
Classification |
| |
Features
|
| |
Development
Stage |
| |
Expected
Launch Date |
| |
Target
Indication |
|
| Microwave ablation catheters | | | Class III catheters | | |
Comprises four different models of catheters
(i)
with water-cooling structure or non-water cooling structure; and
(ii)
with or without laser navigation system
Water-cooling structure features the use of special engineering plastics and a water cycle structure to ensure product quality and lower cost
Laser navigation system allows doctors to locate the position of the catheter inside the blood vessel
Composed of semi-flexible needle with circular tip
Applicable to microwave ablation treatment targeting intestine and blood vessel
Intended to be applied for tumors in varicose vein
|
| | Clinical trial preparation | | | Fourth quarter of 2025 | | | For the treatment of tumors in varicose veins | |
| Endoscope-guided puncture microwave ablation needles | | | Class III | | |
Composed of semi-flexible needle
Allows precise ablation inside patient’s lung with the guidance of endoscope
Applicable to treatment targeting lung tumors
Intended to be applied for pulmonary nodule
|
| | Clinical trial preparation | | | Fourth quarter of 2025 | | | Indicated for pulmonary nodules | |
| Microwave Ablation Therapy Device and Disposable Microwave Ablation Needle | | | Class III | | |
Suitable for microwave ablation treatment of large tumors. Using solid-state power supply as the microwave emission source, no-load status can be detected to ensure
|
| | Clinical trial preparation | | | Fourth quarter of 2025 | | |
Breast lump
|
|
|
Product Category
|
| |
NMPA
Classification |
| |
Features
|
| |
Development
Stage |
| |
Expected
Launch Date |
| |
Target
Indication |
|
| | | | | | |
the safety of clinical use
Equipped with LED display and user-friendly interface
Used with different proprietary microwave ablation needles to treat different conditions
|
| | | | | | | | | |
| | | | |
Lease Square Meters
|
| |
Lease Term
|
| |
Rental Fee
|
|
| | Changcheng Nanjing’s Manufacturing Site | | | 2660 m2 | | | From November 1, 2020 to October 31, 2025 | | |
The annual rent, including taxes, amounts to RMB 1,053,360.
The total annual property fee amounts to RMB 63,840.
|
|
| | Baide Suzhou’s Manufacturing Site | | | 3,841.94 m2 | | | From August 1, 2022 to July 31, 2025 | | |
The annual rent, including taxes, amounts to RMB 1,176,401.34.
The total annual property fee amounts to RMB 138,309.84.
|
|
| | Guoke Baide’s Business Site (Guangzhou) | | | 1,425.78 m2 | | | From October 1, 2022 to September 30, 2027 | | |
The annual rent, including taxes, amounts to RMB 783,360.00.
The total annual property fee amounts to RMB 222,421.68.
|
|
|
Application/ Registration Number |
| |
Name
|
| |
Type
|
| |
Owner
|
| |
Jurisdiction
|
| |
Date of
Application (DD/MM/YYYY) |
| |
Date of
Registration (DD/MM/YYYY) |
| |
Date of
Patent Expiration (DD/MM/YYYY) |
| |
Status
|
|
| 201310552850.8 | | |
Semi-rigid water-cooled microwave ablation antenna with real-time temperature measurement and ablation
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
11/11/2013
|
| |
08/06/2016
|
| |
10/11/2033
|
| |
Granted
|
|
| 201730566463.9 | | | Bent shank ablation needle | | |
Design
|
| |
Baide
Suzhou |
| |
PRC
|
| |
16/11/2017
|
| |
15/06/2018
|
| |
15/11/2027
|
| |
Granted
|
|
| 201730566990.X | | | Microwave therapy instrument | | |
Design
|
| |
Baide
Suzhou |
| |
PRC
|
| |
16/11/2017
|
| |
15/06/2018
|
| |
15/11/2027
|
| |
Granted
|
|
| 201730566996.7 | | | Straight ablation needle | | |
Design
|
| |
Baide
Suzhou |
| |
PRC
|
| |
16/11/2017
|
| |
15/06/2018
|
| |
15/11/2027
|
| |
Granted
|
|
| 201820441845.8 | | |
A kind of water-cooled microwave ablation needle and its fluid injection and wicking structure, metal outer bush
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
30/03/2018
|
| |
05/07/2019
|
| |
29/03/2028
|
| |
Granted
|
|
| 201820501435.8 | | |
A kind of soft microwave melt needle of penetration type half and its water-cooling structure, outer bush
|
| |
Utility
|
| |
Baide
Suzhou, Ligong Lu |
| |
PRC
|
| |
10/04/2018
|
| |
05/07/2019
|
| |
09/04/2028
|
| |
Granted
|
|
| 201820981010.1 | | |
A kind of wireless remote control medical microwave equipment
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
25/06/2018
|
| |
20/08/2019
|
| |
24/06/2028
|
| |
Granted
|
|
| 201830352165.4 | | | Microwave therapy instrument | | |
Design
|
| |
Baide
Suzhou |
| |
PRC
|
| |
03/07/2018
|
| |
08/01/2019
|
| |
02/07/2028
|
| |
Granted
|
|
| 201830492179.6 | | |
Intelligent microwave therapy device
|
| |
Design
|
| |
Baide
Suzhou |
| |
PRC
|
| |
03/09/2018
|
| |
15/01/2019
|
| |
02/09/2028
|
| |
Granted
|
|
| 201821746518.X | | |
A kind of high performance water cooling microwave melt needle with microwave power control switch
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
26/10/2018
|
| |
03/09/2019
|
| |
25/10/2028
|
| |
Granted
|
|
| 201821770152.X | | |
A kind of soft type water cooling microwave coagulation electrode of cup head half
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
30/10/2018
|
| |
03/09/2019
|
| |
29/10/2028
|
| |
Granted
|
|
| 2016208508740 | | |
Anti-microwave interference temperature measurement and ablation integrated high-performance water-cooled microwave ablation antenna
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
08/08/2016
|
| |
14/07/2017
|
| |
07/08/2026
|
| |
Granted
|
|
| 201620850875.5 | | |
Anti-microwave interference temperature measurement and ablation integrated semi-rigid water-cooled microwave ablation antenna
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
08/08/2016
|
| |
25/07/2017
|
| |
07/08/2026
|
| |
Granted
|
|
|
Application/ Registration Number |
| |
Name
|
| |
Type
|
| |
Owner
|
| |
Jurisdiction
|
| |
Date of
Application (DD/MM/YYYY) |
| |
Date of
Registration (DD/MM/YYYY) |
| |
Date of
Patent Expiration (DD/MM/YYYY) |
| |
Status
|
|
| 202121414473.8 | | |
Semi-rigid puncture type microwave ablation antenna and transmission line structure
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
24/06/2021
|
| |
24/12/2021
|
| |
23/06/2031
|
| |
Granted
|
|
| 202121419209.3 | | |
Semi-flexible microwave ablation antenna and transmission line structure
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
24/06/2021
|
| |
24/12/2021
|
| |
23/06/2031
|
| |
Granted
|
|
| 202222076953.9 | | |
A multi-compartment vacuum sterilizer
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
08/08/2022
|
| |
11/04/2023
|
| |
07/08/2032
|
| |
Granted
|
|
| 202222210986.8 | | |
An auxiliary locating device for precise location
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
22/08/2022
|
| |
31/01/2023
|
| |
21/08/2032
|
| |
Granted
|
|
| 202320016679.8 | | |
An adjustable production fixture
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
03/01/2023
|
| |
28/04/2023
|
| |
02/01/2033
|
| |
Granted
|
|
| 202222143353.X | | |
A multi-station synchronous cleaning device
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
15/08/2022
|
| |
31/01/2023
|
| |
14/08/2032
|
| |
Granted
|
|
| 202221848513.4 | | |
A disposable microwave ablation needle with detectable temperature
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
18/07/2022
|
| |
31/01/2023
|
| |
17/07/2032
|
| |
Granted
|
|
| 202221814329.8 | | |
Disposable microwave ablation needle with multiple size interfaces
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
13/07/2022
|
| |
31/01/2023
|
| |
12/07/2032
|
| |
Granted
|
|
| 202221814263.2 | | |
A disposable microwave ablation needle capable of precisely locating
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
13/07/2022
|
| |
31/01/2023
|
| |
12/07/2032
|
| |
Granted
|
|
| 202221764561.5 | | |
A disposable microwave ablation needle convenient for holding
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
07/07/2022
|
| |
31/01/2023
|
| |
06/07/2032
|
| |
Granted
|
|
| 202221853161.1 | | |
Disposable microwave ablation needle with good cooling effect
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
18/07/2022
|
| |
31/01/2023
|
| |
17/07/2032
|
| |
Granted
|
|
| 201810275391.6 | | |
A liquid injection and aspiration structure suitable for microwave ablation needles
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
30/03/2018
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 201810315657.5 | | |
Water-cooled structure of puncture semi-flexible microwave ablation needle
|
| |
Invention
|
| |
Baide
Suzhou, Ligong Lu |
| |
PRC
|
| |
10/04/2018
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 201811226979.9 | | |
A kind of hydrostatic microwave ablation treatment device with semi-puncture type under endoscopic guidance
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
22/10/2018
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 201811258042.X | | |
A high-performance water-cooled microwave ablation needle with microwave power control switch
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
26/10/2018
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202110704940.9 | | |
Semi-rigid puncture type microwave ablation antenna, transmission line structure and assembling method thereof
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
24/06/2021
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202110705763.6 | | |
Semi-flexible microwave ablation antenna, transmission line structure and assembling method
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
24/06/2021
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202320466324.9 | | |
An automatic drying device for automatic drying
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
13/03/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202222281392.6 | | |
A microwave ablation needle that is resistant to bending and breakage
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
29/08/2022
|
| |
20/06/2023
|
| |
28/08/2032
|
| |
Granted
|
|
| 202222076345.8 | | |
A disposable microwave ablation needle that avoids bending of the needle
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
08/08/2022
|
| |
20/06/2023
|
| |
07/08/2032
|
| |
Granted
|
|
|
Application/ Registration Number |
| |
Name
|
| |
Type
|
| |
Owner
|
| |
Jurisdiction
|
| |
Date of
Application (DD/MM/YYYY) |
| |
Date of
Registration (DD/MM/YYYY) |
| |
Date of
Patent Expiration (DD/MM/YYYY) |
| |
Status
|
|
| 202320471098.3 | | |
A microwave ablation antenna that is easy to assemble
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
13/03/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202222143142.6 | | |
An anti-slip disposable microwave ablation needle
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
15/08/2022
|
| |
20/06/2023
|
| |
14/08/2032
|
| |
Granted
|
|
| 202320151590.2 | | |
A microwave ablation needle that rotates the connection
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
01/02/2023
|
| |
07/07/2023
|
| |
31/01/2033
|
| |
Granted
|
|
| 202320058633.2 | | |
A sterile storage room for sterile storage
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
09/01/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202222210863.4 | | |
A radiofrequency ablation device with efficient cooling
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
22/08/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 2023203574500 | | |
An assembly device that is automatically positioned
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
01/03/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202222281897.2 | | |
A detachable microwave ablation needle
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
29/08/2022
|
| |
20/06/2023
|
| |
28/08/2032
|
| |
Granted
|
|
| 2023203047004 | | |
A quick-cooled disposable microwave ablation needle with a needle tip
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
24/02/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202320151600.2 | | |
An integrated microwave ablation antenna
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
01/02/2023
|
| |
20/06/2023
|
| |
31/01/2033
|
| |
Granted
|
|
| 202210802707.9 | | |
Ablation needle assembly and ablation system convenient for secondary puncture
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
07/07/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202310003383.7 | | |
An ablation needle assembly and ablation system that defines the direction of ablation
|
| |
Invention
|
| |
Baide
Suzhou |
| |
PRC
|
| |
03/01/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 201310130580.1 | | |
Microwave thermotherapy radiator with suppression of microwave leakage energy
|
| |
Invention
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
16/04/2013
|
| |
02/03/2016
|
| |
15/04/2033
|
| |
Granted
|
|
| 201310102228.7 | | |
Semi-rigid water-cooled microwave ablation antenna
|
| |
Invention
|
| |
Changcheng
Nanjing, LU Ligong |
| |
PRC
|
| |
27/03/2013
|
| |
16/03/2016
|
| |
26/03/2033
|
| |
Granted
|
|
| 201821706733.7 | | |
One kind semi-rigid penetration type water cooling microwave coagulation therapy instrument under endoscope guidance
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
22/10/2018
|
| |
29/10/2019
|
| |
21/10/2028
|
| |
Granted
|
|
| 201920547932.6 | | |
A semi-rigid intravascular tissue microwave thermal coagulation antenna
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
22/04/2019
|
| |
31/03/2020
|
| |
21/04/2029
|
| |
Granted
|
|
| 201920547772.5 | | |
High-performance semi-rigid puncture type microwave ablation antenna
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
22/04/2019
|
| |
21/02/2020
|
| |
21/04/2029
|
| |
Granted
|
|
| 201920555560.1 | | |
A water-cooled microwave burning hot coagulation knife
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
23/04/2019
|
| |
18/02/2020
|
| |
22/04/2029
|
| |
Granted
|
|
| 201922082885.5 | | |
A multi-probe interventional by-open temperature measuring device
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
27/11/2019
|
| |
23/10/2020
|
| |
26/11/2029
|
| |
Granted
|
|
| 201930687094.8 | | |
Ultrasound diagnosis and tumor microwave ablation treatment machine
|
| |
Design
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
13/12/2019
|
| |
04/08/2020
|
| |
12/12/2029
|
| |
Granted
|
|
| 202022881052.8 | | |
A device for reducing magnetron power fluctuations
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
02/12/2020
|
| |
24/08/2021
|
| |
01/12/2030
|
| |
Granted
|
|
| 202220842531.5 | | |
A magnetron microwave power detection device
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
13/04/2022
|
| |
13/09/2022
|
| |
12/04/2032
|
| |
Granted
|
|
|
Application/ Registration Number |
| |
Name
|
| |
Type
|
| |
Owner
|
| |
Jurisdiction
|
| |
Date of
Application (DD/MM/YYYY) |
| |
Date of
Registration (DD/MM/YYYY) |
| |
Date of
Patent Expiration (DD/MM/YYYY) |
| |
Status
|
|
| 202221501397.9 | | |
A power detection device with open circuit protection and short circuit protection
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
16/06/2022
|
| |
13/12/2022
|
| |
15/06/2032
|
| |
Granted
|
|
| 202221698800.1 | | |
A medical catheter with a multi-point mapping structure for radiofrequency ablation
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
04/07/2022
|
| |
13/12/2022
|
| |
03/07/2032
|
| |
Granted
|
|
| ZL202321169155.9 | | |
An ablation device with a retractable treatment handle
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
16/05/2023
|
| |
19/09/2023
|
| |
15/05/2033
|
| |
Granted
|
|
| ZL202321169160.X | | |
A Migration Resistant Radiofrequency Ablation Needle
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
15/05/2023
|
| |
19/09/2023
|
| |
14/05/2033
|
| |
Granted
|
|
| 201910322669.5 | | |
A kind of semi-rigid type endovascular tissue microwave thermal solidification antenna
|
| |
Invention
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
22/04/2019
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 201910322654.9 | | |
A kind of high-performance semi-rigid penetration type microwave ablation antenna
|
| |
Invention
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
22/04/2019
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 201910327277.8 | | |
A water-cooled microwave burning hot coagulation knife
|
| |
Invention
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
22/04/2019
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202220649092.6 | | |
For microwave ablation catheters under bronchoscopy
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
23/03/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202210538324.5 | | |
Cloud-based computer-based radiofrequency ablation catheter and its method for precise control of ablation depth
|
| |
Invention
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
18/05/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202221353964.0 | | |
A temperature measuring device with motion detection function for high-power magnetron
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
01/06/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202221390369.4 | | |
A radiofrequency ablation device with a rapid cooling structure
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
06/06/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202221390373.0 | | |
A radiofrequency ablation catheter with a mechanically supported structure
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
06/06/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202221518957.1 | | |
A radiofrequency ablation device with a rapid cooling structure
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
17/06/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202221588173.6 | | |
Temperature control equipment for radiofrequency ablation catheter
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
23/06/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202221698806.9 | | |
A medical display with a multi-angle adjustment mechanism for radiofrequency ablation
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
04/07/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202222027126.0 | | |
A kind of microwave ablation therapy instrument with a power control device with a socket fixed structure
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
03/08/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202222027085.5 | | |
A safety detection device for positioning stable structure of microwave therapy appliances
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
03/08/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202222180068.5 | | |
An intelligent microwave therapy instrument has a probe connection bracket for adjusting the mechanism
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
19/08/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202320862108.6 | | |
A microwave therapy device with a multi-angle treatment adjustment structure
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
18/04/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
|
Application/ Registration Number |
| |
Name
|
| |
Type
|
| |
Owner
|
| |
Jurisdiction
|
| |
Date of
Application (DD/MM/YYYY) |
| |
Date of
Registration (DD/MM/YYYY) |
| |
Date of
Patent Expiration (DD/MM/YYYY) |
| |
Status
|
|
| 202320862105.2 | | |
A smart microwave therapy device with an adjustable probe connection bracket
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
18/04/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202320862106.7 | | |
A radiofrequency ablation instrument with a folding bracket structure
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
18/04/2023
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202221872954.8 | | |
A microwave leakage suppressor that can be replaced by microwave absorbing materials
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
21/07/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 202321066822.0 | | |
A pin detection and identification circuit
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
06/05/2023
|
| |
19/12/2023
|
| |
05/05/2033
|
| |
Granted
|
|
| 202321076647.3 | | |
A no-load protection circuit for microwave ablators
|
| |
Utility
|
| |
Changcheng
Nanjing |
| |
PRC
|
| |
06/05/2023
|
| |
03/10/2023
|
| |
05/05/2033
|
| |
Granted
|
|
| 202211531889.7 | | |
Photothermal rare earth nanoprobe and preparation method thereof
|
| |
Invention
|
| |
Ruikede
Xiamen |
| |
PRC
|
| |
01/12/2022
|
| |
N/A
|
| |
N/A
|
| |
Pending
|
|
| 201620850874.0 | | |
High-performance water-cooled microwave ablation antenna with integrated microwave-resistant temperature measurement and ablation
|
| |
Utility
|
| |
Baide
Suzhou |
| |
PRC
|
| |
08/08/2016
|
| |
12/06/2017
|
| |
07/08/2026
|
| |
Granted
|
|
|
Function
|
| |
Number
|
| |||
|
Procurement
|
| | | | 4 | | |
|
Quality Control
|
| | | | 16 | | |
|
Finance
|
| | | | 7 | | |
|
Sales and Marketing
|
| | | | 25 | | |
|
Production
|
| | | | 48 | | |
|
Research and Development and Technical
|
| | | | 12 | | |
|
Administration and General Management
|
| | | | 17 | | |
|
Total
|
| | | | 129 | | |
| | | |
Year Ended December 31,
|
| |
For the six months ended June 30,
|
| ||||||||||||||||||||||||
| | | |
2022
|
| |
2023
|
| |
2024
|
| |
2024
|
| |
2025
|
| |||||||||||||||
| | | |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |||||||||||||||
|
Revenues
|
| | | $ | 35,091,174 | | | | | $ | 31,457,908 | | | | | $ | 37,037,108 | | | | | $ | 13,136,588 | | | | | $ | 7,959,494 | | |
|
Cost of revenues
|
| | | | (7,054,323) | | | | | | (4,227,409) | | | | | | (4,383,363) | | | | | | (1,645,559) | | | | | | (1,424,240) | | |
|
Gross profit
|
| | | | 28,036,851 | | | | | | 27,230,499 | | | | | | 32,653,745 | | | | | | 11,491,029 | | | | | | 6,535,254 | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | | | | ||||||||||
|
Selling and marketing expenses
|
| | | | (3,585,138) | | | | | | (2,547,000) | | | | | | (4,061,116) | | | | | | (1,168,576) | | | | | | (1,127,725) | | |
|
General and administrative
expenses |
| | | | (6,960,604) | | | | | | (8,546,880) | | | | | | (7,103,226) | | | | | | (3,205,845) | | | | | | (8,677,640) | | |
|
Research and development
expenses |
| | | | (3,859,392) | | | | | | (4,274,894) | | | | | | (6,174,365) | | | | | | (2,027,439) | | | | | | (7,180,293) | | |
|
Total operating expenses
|
| | | | (14,405,134) | | | | | | (15,368,774) | | | | | | (17,338,707) | | | | | | (6,401,860) | | | | | | 16,985,658 | | |
|
Income from operations
|
| | | | 13,631,717 | | | | | | 11,861,725 | | | | | | 15,315,038 | | | | | | 5,089,169 | | | | | | (10,450,404) | | |
|
Interest expense
|
| | | | (299,269) | | | | | | (285,833) | | | | | | (576,752) | | | | | | (238,919) | | | | | | (358,215) | | |
|
Interest income
|
| | | | 8,553 | | | | | | 1,562 | | | | | | 393 | | | | | | 264 | | | | | | 762 | | |
|
Subsidy income
|
| | | | 1,375,447 | | | | | | 791,959 | | | | | | 266 | | | | | | 265 | | | | | | 56,968 | | |
|
Other expenses, net
|
| | | | (194,580) | | | | | | (10,211) | | | | | | (651,657) | | | | | | 5,627 | | | | | | (49,107) | | |
|
Income/(loss) before income tax
|
| | | | 14,521,868 | | | | | | 12,359,202 | | | | | | 14,087,288 | | | | | | 4,856,406 | | | | | | (10,799,996) | | |
|
Income tax provision
|
| | | | (1,746,897) | | | | | | (1,701,019) | | | | | | (1,489,190) | | | | | | (481,279) | | | | | | (559,131) | | |
|
Net income/(loss)
|
| | | $ | 12,774,971 | | | | | $ | 10,658,183 | | | | | $ | 12,598,098 | | | | | $ | 4,375,127 | | | | | $ | (11,359,127) | | |
|
Other comprehensive loss, net of tax
|
| | | | | | | | | | | | | | | | | | | | | ||||||||||
|
Foreign currency translation adjustment
|
| | | $ | (1,506,905) | | | | | $ | (728,688) | | | | | $ | (1,135,939) | | | | | $ | (828,730) | | | | | $ | 893,939 | | |
|
Comprehensive income/(loss)
|
| | | $ | 11,268,066 | | | | | $ | 9,929,495 | | | | | $ | 11,462,159 | | | | | $ | 3,546,397 | | | | | $ | (10,465,188) | | |
|
Net income/(loss) attributable to controlling shareholders
|
| | | $ | 12,568,750 | | | | | $ | 10,545,978 | | | | | $ | 12,453,369 | | | | | $ | 3,501,537 | | | | | $ | (10,399,956) | | |
|
Basic income/(loss) per common
share |
| | | | 0.49 | | | | | | 0.41 | | | | | | 0.49 | | | | | | 0.17 | | | | | | (0.43) | | |
|
Diluted income/(loss) per common share
|
| | | | 0.49 | | | | | | 0.41 | | | | | | 0.49 | | | | | | 0.17 | | | | | | (0.43) | | |
| | | |
For the years ended
December 31, |
| |||||||||
| | | |
2023
|
| |
2022
|
| ||||||
| Distributors(3) | | | | $ | 14,995,701 | | | | | $ | 13,499,170 | | |
|
Direct customers(1)(2)
|
| | | | 16,462,207 | | | | | | 21,592,004 | | |
|
Total
|
| | | $ | 31,457,908 | | | | | $ | 35,091,174 | | |
| | | |
For the Year Ended December 31,
|
| |||||||||||||||||||||||||||||||||
| | | |
2023
|
| |
2022
|
| |
Variance
|
| |
Variance %
|
| ||||||||||||||||||||||||
| | | |
Revenue
|
| |
%
|
| |
Revenue
|
| |
%
|
| ||||||||||||||||||||||||
|
Sales of MWA devices
|
| | | $ | 30,940,383 | | | | | | 98% | | | | | $ | 31,283,234 | | | | | | 89% | | | | | $ | (342,851) | | | | | | (1)% | | |
|
– MWA needles
|
| | | | 26,278,169 | | | | | | 84% | | | | | | 30,551,145 | | | | | | 87% | | | | | | (4,272,976) | | | | | | (14)% | | |
|
– MWA therapeutic apparatus
|
| | | | 4,662,214 | | | | | | 14% | | | | | | 732,089 | | | | | | 2% | | | | | | 3,930,125 | | | | | | 537% | | |
|
Sales of other medical devices
|
| | | | 517,525 | | | | | | 2% | | | | | | 3,807,940 | | | | | | 11% | | | | | | (3,290,415) | | | | | | (86)% | | |
| Total | | | | $ | 31,457,908 | | | | | | 100.0% | | | | | $ | 35,091,174 | | | | | | 100.0% | | | | | $ | (3,633,266) | | | | | | (10.4)% | | |
| | | |
As of
|
| |||||||||
| | | |
December 31, 2024
|
| |
June 30, 2025
|
| ||||||
|
Not Overdue
|
| | | $ | 13,225,014 | | | | | $ | 5,008,950 | | |
|
Within 90 days
|
| | | | 9,983,041 | | | | | | 1,172,740 | | |
|
Between 3 and 6 months
|
| | | | 7,247,650 | | | | | | 12,210,320 | | |
|
Between 6 months and a year
|
| | | | 11,801,484 | | | | | | 14,579,290 | | |
|
Over a year
|
| | | | 8,311,509 | | | | | | 11,922,010 | | |
| | | | | $ | 50,568,698 | | | | | $ | 44,893,310 | | |
as of December 31, 2023 and December 31, 2024
average accounts receivable × 180 days ÷ sales revenue = turnover days of accounts receivable
as of June 30, 2025
average accounts receivable = (opening accounts receivable balance + closing accounts receivable balance) / 2
| | | |
As of
|
| |||||||||
| | | |
December 31, 2024
|
| |
June 30, 2025
|
| ||||||
| Due from related parties: | | | | | | | | | | | | | |
|
Haimei Wu(1)
|
| | | $ | — | | | | | $ | — | | |
|
Betters Medical Investment Holdings Limited
|
| | | | 2,862 | | | | | | 2,916 | | |
|
Total
|
| | | $ | 2,862 | | | | | $ | 2,916 | | |
| Due to related parties: | | | | | | | | | | | | | |
|
Betters Medical Investment Holdings Limited(2)
|
| | | $ | 3,703,700 | | | | | $ | 4,502,547 | | |
|
Total
|
| | | $ | 3,703,700 | | | | | $ | 4,502,547 | | |
| | | |
For the year ended December 31,
|
| |
For the Six Months
ended June 30, |
| ||||||||||||||||||||||||
| | | |
2022
|
| |
2023
|
| |
2024
|
| |
2024
|
| |
2025
|
| |||||||||||||||
| | | |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |
US$
|
| |||||||||||||||
|
Net cash provided by (used in) operating
activities |
| | | $ | 485,968 | | | | | $ | (1,019,964) | | | | | $ | (6,313,115) | | | | | $ | (3,960,397) | | | | | $ | (3,194,035) | | |
|
Net cash (used in) investing activities
|
| | | | (5,921,464) | | | | | | (2,638,488) | | | | | | (2,853,678) | | | | | | (484,839) | | | | | | (44,610) | | |
|
Net cash provided by financing
activities |
| | | | 4,411,918 | | | | | | 3,461,118 | | | | | | 10,720,781 | | | | | | 4,457,217 | | | | | | 2,195,443 | | |
|
Effect of exchange rate change
|
| | | | (297,647) | | | | | | (3,108) | | | | | | (94,273) | | | | | | (20,051) | | | | | | 244,495 | | |
|
Net (decrease) increase in cash and cash equivalent
|
| | | | (1,321,225) | | | | | | (200,442) | | | | | | 1,459,715 | | | | | | (8,070) | | | | | | (798,707) | | |
|
Cash and cash equivalent at the beginning
of the period |
| | | | 3,032,151 | | | | | | 1,710,926 | | | | | | 1,510,484 | | | | | | 1,510,484 | | | | | | 2,970,199 | | |
|
Cash and cash equivalent at the end of the period
|
| | | $ | 1,710,926 | | | | | $ | 1,510,484 | | | | | $ | 2,970,199 | | | | | $ | 1,502,414 | | | | | $ | 2,171,492 | | |
| | | |
Payment Due by Period
|
| |||||||||||||||
| | | |
Total
|
| |
Less than 1 Year
|
| |
1 – 3 Years
|
| |||||||||
|
Short-term bank loans
|
| | | $ | 13,953,020 | | | | | $ | 13,953,020 | | | | | $ | — | | |
|
Lease payment
|
| | | | 204,490 | | | | | | 115,481 | | | | | | 89,009 | | |
|
Long term loan
|
| | | | 8,405,830 | | | | | | 2,591,659 | | | | | | 5,814,171 | | |
|
Total
|
| | | $ | 22,563,340 | | | | | $ | 16,660,160 | | | | | $ | 5,903,180 | | |
| | | |
For the six months ended June 30,
|
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Net Income/ (Net Loss)
|
| | | $ | 4,375,127 | | | | | $ | (11,359,127) | | |
|
(+) Depreciation and Amortization
|
| | | | 773,962 | | | | | | 789,932 | | |
|
(+) Share-based compensation
|
| | | | — | | | | | | 6,328,781 | | |
|
(+) Income Tax
|
| | | | 481,279 | | | | | | 559,131 | | |
|
(+) Interest Expenses, net
|
| | | | 238,655 | | | | | | 357,453 | | |
|
(+) Listing Expenses
|
| | | | 1,217,151 | | | | | | — | | |
|
Adjusted EBITDA
|
| | | $ | 7,086,174 | | | | | $ | (3,323,830) | | |
| | | |
Individual basis
|
| |
Aging group basis
|
| |
Total
|
| |||||||||
|
Trade accounts receivable
|
| | | $ | 1,991,596 | | | | | $ | 31,949,487 | | | | | $ | 33,941,083 | | |
|
Less: allowance for doubtful accounts
|
| | | | (1,991,596) | | | | | | (849,596) | | | | | | (2,841,192) | | |
|
Accounts receivable, net
|
| | | | — | | | | | $ | 31,099,891 | | | | | $ | 31,099,891 | | |
|
Allowance Ratio
|
| | | | 100% | | | | | | 2.7% | | | | | | 8.4% | | |
| | | |
lndividual basis
|
| |
Aging group basis
|
| |
Total
|
| |||||||||
|
Trade accounts receivable
|
| | | $ | 2,098,602 | | | | | | 48,470,096 | | | | | | 50,568,698 | | |
|
Less: allowance for doubtful accounts
|
| | | | (2,098,602) | | | | | | (1,894,320) | | | | | | (3,992,922) | | |
|
Accounts receivable, net
|
| | | | — | | | | | | 46,575,776 | | | | | | 46,575,776 | | |
|
Allowance Ratio
|
| | | | 100% | | | | | | 3.9% | | | | | | 7.9% | | |
| | | |
Individual basis
|
| |
Aging group basis
|
| |
Total
|
| |||||||||
|
Trade accounts receivable
|
| | | $ | 2,138,430 | | | | | | 42,754,880 | | | | | | 44,893,310 | | |
|
Less: allowance for doubtful accounts
|
| | | | (2,138,430) | | | | | | (1,929,885) | | | | | | (4,068,315) | | |
|
Accounts receivable, net
|
| | | | — | | | | | | 40,824,995 | | | | | | 40,824,995 | | |
|
Allowance Ratio
|
| | | | 100% | | | | | | 4.5% | | | | | | 9.1% | | |
|
Name
|
| |
Age
|
| |
Position
|
|
| Directors | | | | | | | |
| Haimei Wu | | |
43
|
| |
Chairwoman of the Board of Directors and Chief Executive Officer
|
|
| Wei Hou | | |
55
|
| | Director | |
| Quan Qiu | | |
32
|
| | Director and Chief Administrative Officer | |
| Joseph Douglas Ragan III | | |
63
|
| | Director | |
| Michael Mingzhao Xing | | |
61
|
| | Director | |
| Lijian Xu | | |
61
|
| | Director | |
| Gabrielle Bilciu-Wolfson | | |
63
|
| | Director | |
| Executive Officers | | | | | | | |
| Rongjian Lu | | |
59
|
| | Chief Technical Officer and Deputy General Manager | |
| Jie Li | | |
38
|
| | Acting Chief Financial Officer | |
|
Beneficial Owners
|
| |
Number of
Ordinary Shares |
| |
Percentage of
all Ordinary Shares |
| |
Percentage
of all Voting Power |
| |||||||||
| 5% shareholders: | | | | | | | | | | | | | | | | | | | |
|
Haimei Wu(1)
|
| | | | 18,295,281 | | | | | | 49.4% | | | | | | 49.4% | | |
|
ExcelFin SPAC LLC
|
| | | | 4,773,406 | | | | | | 12.9% | | | | | | 12.9% | | |
|
Grand Fortune Capital (H.K.) Company Limited(2)
|
| | | | 2,754,985 | | | | | | 7.4% | | | | | | 7.4% | | |
| Directors and Executive Officers | | | | | | | | | | | | | | | | | | | |
|
Haimei Wu(1)
|
| | | | 18,295,281 | | | | | | 49.4% | | | | | | 49.4% | | |
|
Wei Hou
|
| | | | * | | | | | | * | | | | | | * | | |
|
Quan Qiu
|
| | | | — | | | | | | — | | | | | | — | | |
|
Joseph Douglas Ragan III
|
| | | | * | | | | | | * | | | | | | * | | |
|
Michael Mingzhao Xing
|
| | | | * | | | | | | * | | | | | | * | | |
|
Lijian Xu
|
| | | | * | | | | | | * | | | | | | * | | |
|
Gabrielle Bilciu-Wolfson
|
| | | | * | | | | | | * | | | | | | * | | |
|
Rongjian Lu
|
| | | | — | | | | | | — | | | | | | — | | |
|
Jie Li
|
| | | | — | | | | | | — | | | | | | — | | |
|
Jianwei Yuan
|
| | | | — | | | | | | — | | | | | | — | | |
|
Jin Xu
|
| | | | — | | | | | | — | | | | | | — | | |
|
Wei Xu
|
| | | | — | | | | | | — | | | | | | — | | |
|
All directors and executive officers as a group
|
| | | | 18,519,026 | | | | | | 50.0% | | | | | | 50.0% | | |
| | | |
Securities
beneficially owned prior to this offering |
| |
Securities to
be sold in this offering |
| |
Securities beneficially
owned after this offering |
| |||||||||||||||||||||
|
Name of Selling Securityholder
|
| |
Ordinary
Shares |
| |
%(1)
|
| |
Ordinary
Shares |
| |
Ordinary
Shares(1)(2) |
| |
%(1)(2)
|
| |||||||||||||||
|
ExcelFin SPAC LLC(3)
|
| | | | 4,773,406 | | | | | | 12.9 | | | | | | 4,773,406 | | | | | | — | | | | | | — | | |
|
Nautilus Master Fund LP(4)
|
| | | | 125,000 | | | | | | 0.3 | | | | | | 125,000 | | | | | | — | | | | | | — | | |
|
Highbridge Tactical Credit Master Fund LP(5)
|
| | | | 99,625 | | | | | | 0.3 | | | | | | 99,625 | | | | | | — | | | | | | — | | |
|
Highbridge Tactical Credit Institutional Fund Ltd(6)
|
| | | | 25,375 | | | | | | 0.1 | | | | | | 25,375 | | | | | | — | | | | | | — | | |
|
Radcliffe SPAC Master Fund LP(7)
|
| | | | 125,000 | | | | | | 0.3 | | | | | | 125,000 | | | | | | — | | | | | | — | | |
|
Fir Tree Value Master Fund LP(8)
|
| | | | 1,669 | | | | | | * | | | | | | 1,669 | | | | | | — | | | | | | — | | |
|
Fir Tree Capital Opportunity Master Fund LP(9)
|
| | | | 1,018 | | | | | | * | | | | | | 1,018 | | | | | | — | | | | | | — | | |
|
Fir Tree Capital Opportunity Master Fund III LP(10)
|
| | | | 1,667 | | | | | | * | | | | | | 1,667 | | | | | | — | | | | | | — | | |
|
FT SOF XIII (SPAC) Holdings LLC(11)
|
| | | | 24,225 | | | | | | 0.1 | | | | | | 24,225 | | | | | | — | | | | | | — | | |
|
Boston Patriot Merrimack St LLC(12)
|
| | | | 96,421 | | | | | | 0.3 | | | | | | 96,421 | | | | | | — | | | | | | — | | |
|
Camac Fund LP(13)
|
| | | | 75,000 | | | | | | 0.2 | | | | | | 75,000 | | | | | | — | | | | | | — | | |
|
Exos Collateralized SPAC Holdings Fund LP(14)
|
| | | | 80,000 | | | | | | 0.2 | | | | | | 80,000 | | | | | | — | | | | | | — | | |
|
AQR Absolute Return Master Account LP(15)
|
| | | | 7,735 | | | | | | 0.0 | | | | | | 7,735 | | | | | | — | | | | | | — | | |
|
AQR SPAC Opportunities Offshore Fund LP(16)
|
| | | | 3,425 | | | | | | * | | | | | | 3,425 | | | | | | — | | | | | | — | | |
|
AQR TA Global Alpha Fund LP(17)
|
| | | | 5,036 | | | | | | 0.0 | | | | | | 5,036 | | | | | | — | | | | | | — | | |
|
AQR Funds – AQR Diversified Arbitrage Fund(18)
|
| | | | 46,529 | | | | | | 0.1 | | | | | | 46,529 | | | | | | — | | | | | | — | | |
|
AQR Global Alternative Investment Offshore Fund LP-
SPACs Sleeve(19) |
| | | | 62,275 | | | | | | 0.2 | | | | | | 62,275 | | | | | | — | | | | | | — | | |
|
James Lee Lapp(20)
|
| | | | 12,500 | | | | | | 0.0 | | | | | | 12,500 | | | | | | — | | | | | | — | | |
|
Perga Capital Partners LP(21)
|
| | | | 50,000 | | | | | | 0.1 | | | | | | 50,000 | | | | | | — | | | | | | — | | |
|
TQ Master Fund LP(22)
|
| | | | 50,000 | | | | | | 0.1 | | | | | | 50,000 | | | | | | — | | | | | | — | | |
|
RLH SPAC Fund LP(23)
|
| | | | 37,500 | | | | | | 0.1 | | | | | | 37,500 | | | | | | — | | | | | | — | | |
|
BoothBay Absolute Return Strategies LP(24)
|
| | | | 33,733 | | | | | | 0.1 | | | | | | 33,733 | | | | | | — | | | | | | — | | |
|
Boothbay Diversified Alpha Master Fund LP(25)
|
| | | | 29,590 | | | | | | 0.1 | | | | | | 29,590 | | | | | | — | | | | | | — | | |
|
Sandia Crest LP(26)
|
| | | | 17,993 | | | | | | 0.0 | | | | | | 17,993 | | | | | | — | | | | | | — | | |
|
Crestline Summit Master SPC – Peak SP(27)
|
| | | | 14,792 | | | | | | 0.0 | | | | | | 14,792 | | | | | | — | | | | | | — | | |
|
Crestline Summit Master SPC – Crestline Summit APEX SP(28)
|
| | | | 3,559 | | | | | | 0.0 | | | | | | 3,559 | | | | | | — | | | | | | — | | |
|
Walleye Opportunities Master Fund Ltd(29)
|
| | | | 16,887 | | | | | | 0.0 | | | | | | 16,887 | | | | | | — | | | | | | — | | |
|
Walleye Investments Fund LLC(30)
|
| | | | 8,446 | | | | | | 0.0 | | | | | | 8,446 | | | | | | — | | | | | | — | | |
|
Tenor Opportunity Master Fund Ltd(31)
|
| | | | 75,000 | | | | | | 0.2 | | | | | | 75,000 | | | | | | — | | | | | | — | | |
|
Fifth Lane Partners Fund LP(32)
|
| | | | 125,000 | | | | | | 0.3 | | | | | | 125,000 | | | | | | — | | | | | | — | | |
|
Auto King International Limited(33)
|
| | | | 18,195,281 | | | | | | 49.2 | | | | | | 18,195,281 | | | | | | — | | | | | | — | | |
|
Brilliant Cut Limited(34)
|
| | | | 1,362,369 | | | | | | 3.7 | | | | | | 1,362,369 | | | | | | — | | | | | | — | | |
|
Daily Charm Holdings Limited(35)
|
| | | | 1,329,505 | | | | | | 3.6 | | | | | | 1,329,505 | | | | | | — | | | | | | — | | |
|
Cosmic Discovery Limited(36)
|
| | | | 765,181 | | | | | | 2.1 | | | | | | 765,181 | | | | | | — | | | | | | — | | |
|
Rainbow Avenue Limited(37)
|
| | | | 697,840 | | | | | | 1.9 | | | | | | 697,840 | | | | | | — | | | | | | — | | |
|
Mighty Sino International Limited(38)
|
| | | | 697,083 | | | | | | 1.9 | | | | | | 697,083 | | | | | | — | | | | | | — | | |
|
Pride Supreme Limited(39)
|
| | | | 480,283 | | | | | | 1.3 | | | | | | 480,283 | | | | | | — | | | | | | — | | |
|
Good Hero Global Limited(40)
|
| | | | 389,738 | | | | | | 1.1 | | | | | | 389,738 | | | | | | — | | | | | | — | | |
| | | |
Securities
beneficially owned prior to this offering |
| |
Securities to
be sold in this offering |
| |
Securities beneficially
owned after this offering |
| |||||||||||||||||||||
|
Name of Selling Securityholder
|
| |
Ordinary
Shares |
| |
%(1)
|
| |
Ordinary
Shares |
| |
Ordinary
Shares(1)(2) |
| |
%(1)(2)
|
| |||||||||||||||
|
Tiger Goal Limited(41)
|
| | | | 293,349 | | | | | | 0.8 | | | | | | 293,349 | | | | | | — | | | | | | — | | |
|
Major Delight Limited(42)
|
| | | | 145,410 | | | | | | 0.4 | | | | | | 145,410 | | | | | | — | | | | | | — | | |
|
Success Avenue Limited(43)
|
| | | | 130,599 | | | | | | 0.4 | | | | | | 130,599 | | | | | | — | | | | | | — | | |
|
Grand Fortune Capital (H.K.) Company Limited(44)
|
| | | | 2,464,985 | | | | | | 6.7 | | | | | | 2,464,985 | | | | | | — | | | | | | — | | |
|
Grand Fortune Capital, LLC(44)
|
| | | | 290,000 | | | | | | 0.8 | | | | | | 290,000 | | | | | | — | | | | | | — | | |
|
Courage Elite Limited(45)
|
| | | | 512,848 | | | | | | 1.4 | | | | | | 512,848 | | | | | | — | | | | | | — | | |
|
China Venture Capital (Hong Kong) Co., Limited(46)
|
| | | | 256,425 | | | | | | 0.7 | | | | | | 256,425 | | | | | | — | | | | | | — | | |
|
IPE Group Limited(47)
|
| | | | 256,425 | | | | | | 0.7 | | | | | | 256,425 | | | | | | — | | | | | | — | | |
|
Weitian Limited(48)
|
| | | | 69,835 | | | | | | 0.2 | | | | | | 69,835 | | | | | | — | | | | | | — | | |
|
J.V.B. Financial Group, LLC(49)
|
| | | | 50,000 | | | | | | 0.1 | | | | | | 50,000 | | | | | | — | | | | | | — | | |
|
Total
|
| | | | 34,415,562 | | | | | | 93.0 | | | | | | 34,415,562 | | | | | | — | | | | | | — | | |
| | |||||||||||||||||||||||||||||||
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| |
Mergers and Similar Arrangements
|
| |
The Companies Act (As Revised) permits mergers and consolidations between Cayman Islands companies and between Cayman Islands companies and non-Cayman Islands companies. For these purposes, (1) “merger” means the merging of two or more constituent companies and the vesting of their undertaking, property and liabilities in one of such companies as the surviving company, and (2) a “consolidation” means the combination of two or more constituent companies into a consolidated company and the vesting of the undertaking, property and liabilities of such companies to the consolidated company. In order to effect such a merger or consolidation, the directors of each constituent company must approve a written plan of merger or consolidation, which must then be authorized by (a) a special resolution of the shareholders of each constituent company, and (b) such other authorization, if any, as may be specified in such constituent company’s articles of association. The written plan of merger or consolidation must be filed with the Registrar of Companies of the Cayman Islands together with a declaration as to the solvency of the surviving or consolidated company, a declaration as to the assets and liabilities of each constituent company, and an undertaking that a copy of the certificate of merger or consolidation will be given to the members and creditors of each constituent company and that notification of the merger or consolidation will be published in the Cayman Islands Gazette. Court approval is not required for a merger or consolidation which is effected in compliance with these statutory procedures.
|
| |
Under Delaware law, with certain exceptions, a merger, a consolidation, or a sale, lease or exchange of all or substantially all the assets of a corporation must be approved by the board of directors and a majority of the outstanding shares entitled to vote thereon. However, unless required by its certificate of incorporation, approval is not required by the holders of the outstanding stock of a constituent corporation surviving a merger if:
•
the merger agreement does not amend in any respect its certificate of incorporation;
•
each share of its stock outstanding prior to the merger will be an identical share of stock following the merger; and
•
either no shares of the surviving corporation’s common stock and no shares, securities or obligations convertible into such stock will be issued or delivered pursuant to the merger, or the authorized unissued shares or treasury shares of the surviving corporation’s common stock to be issued or delivered pursuant to the merger plus those initially issuable upon conversion of any other shares, securities or obligations to be issued or delivered pursuant to the merger do not exceed 20% of the shares of the surviving corporation’s common stock outstanding immediately prior to the effective date of the merger.
|
|
| | | | |
A merger between a Cayman parent company and its Cayman subsidiary or subsidiaries does not require authorization by a resolution of shareholders of that Cayman subsidiary if a copy of the plan of merger is given to every member of that Cayman subsidiary to be merged unless that member agrees otherwise. For this
|
| |
Mergers in which one corporation owns 90% or more of a second corporation may be completed without the vote of the second corporation’s board of directors or stockholders.
|
|
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| | | | |
purpose, a company is a “parent” of a subsidiary if it holds issued shares that together represent at least 90% of the votes at a general meeting of the subsidiary.
|
| | | |
| | | | |
The consent of each holder of a fixed or floating security interest over a constituent company is required unless this requirement is waived by a court in the Cayman Islands.
|
| | | |
| | | | |
Save in certain limited circumstances, a shareholder of a Cayman constituent company who dissents from the merger or consolidation is entitled to payment of the fair value of his shares (which, if not agreed between the parties, will be determined by the Cayman Islands court) upon dissenting to the merger or consolidation; provided that the dissenting shareholder complies strictly with the procedures set out in the Companies Act (As Revised). The exercise of dissenter rights will preclude the exercise by the dissenting shareholder of any other rights to which he or she might otherwise be entitled by virtue of holding shares, save for the right to seek relief on the grounds that the merger or consolidation is void or unlawful.
|
| |
Generally, a stockholder of a publicly traded corporation does not have appraisal rights in connection with a merger.
|
|
| | | | |
Separate from the statutory provisions relating to mergers and consolidations, the Companies Act (As Revised) also contains statutory provisions that facilitate the reconstruction and amalgamation of companies by way of schemes of arrangement; provided that the arrangement is approved by (a) 75% in value of shareholders or class of shareholders, as the case may be, or (b) a majority in number representing 75% in value of the creditors or class of creditors, as the case may be, with whom the arrangement is to be made, that are, in each case, present and voting either in person or by proxy at a meeting, or meetings, convened for that purpose. The convening of the meetings and subsequently the arrangement must be sanctioned by the Grand Court of the Cayman Islands. While a dissenting shareholder has the right to express to the court the view that the transaction ought not to be approved, the court can be expected to approve the arrangement if it determines that:
|
| | ||
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| | | | |
•
the statutory provisions as to the required majority vote have been met;
•
the shareholders have been fairly represented at the meeting in question and the statutory majority are acting bona fide without coercion of the minority to promote interests adverse to those of the class;
•
the arrangement is such that may be reasonably approved by an intelligent and honest man of that class acting in respect of his interest; and
•
the arrangement is not one that would more properly be sanctioned under some other provision of the Companies Act (As Revised).
The Companies Act (As Revised) also contains a statutory power of compulsory acquisition which may facilitate the “squeeze out” of dissentient minority shareholders upon a tender offer. When a tender offer is made and accepted by holders of 90.0% of the shares affected within four months, the offeror may, within a two-month period commencing on the expiration of such four-month period, require the holders of the remaining shares to transfer such shares to the offeror on the terms of the offer. An objection can be made to the Grand Court of the Cayman Islands but this is unlikely to succeed in the case of an offer which has been so approved unless there is evidence of fraud, bad faith or collusion.
|
| | ||
| | | | |
If an arrangement and reconstruction by way of scheme of arrangement is thus approved and sanctioned, or if a tender offer is made and accepted in accordance with the foregoing statutory procedures, a dissenting shareholder would have no rights comparable to appraisal rights, which would otherwise ordinarily be available to dissenting shareholders of Delaware corporations, providing rights to receive payment in cash for the judicially determined value of the shares.
|
| | | |
| |
Shareholders’ Suits
|
| |
In principle, we will normally be the proper plaintiff to sue for a wrong done to us as a company, and as a general rule a derivative action may not be brought by a minority shareholder. However, based on English authorities, which would in all likelihood be
|
| |
Class actions and derivative actions generally are available to stockholders under Delaware law for, among other things, breach of fiduciary duty, corporate waste and actions not taken in accordance with applicable law. In such actions, the
|
|
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| | | | |
of persuasive authority in the Cayman Islands, the Cayman Islands court can be expected to follow and apply the common law principles (namely the rule in Foss v. Harbottle and the exceptions thereto) so that a non-controlling shareholder may be permitted to commence a class action against or derivative actions in the name of the company to challenge actions where:
|
| |
court generally has discretion to permit a winning plaintiff to recover attorneys’ fees incurred in connection with such action.
|
|
| | | | |
•
a company acts or proposes to act illegally or ultra vires;
•
the act complained of, although not ultra vires, could only be effected duly if authorized by more than a simple majority vote that has not been obtained; and
•
those who control the company are perpetrating a “fraud on the minority.”
|
| | | |
| |
Indemnification of Directors and Executive Officers and Limitation of Liability
|
| |
Cayman Islands law does not limit the extent to which a company’s memorandum and articles of association may provide for indemnification of officers and directors, except to the extent any such provision may be held by the Cayman Islands courts to be contrary to public policy, such as to provide indemnification against civil fraud or the consequences of committing a crime. Our Amended and Restated Memorandum and Articles of Association provide that we shall indemnify our directors and officers, against all actions, proceedings, costs, charges, expenses, losses, damages or liabilities incurred or sustained by such directors or officer, other than by reason of such person’s dishonesty, willful default or fraud, in or about the conduct of our company’s business or affairs (including as a result of any mistake of judgment) or in the execution or discharge of his duties, powers, authorities or discretions, including without prejudice to the generality of the foregoing, any costs, expenses, losses or liabilities incurred by such director or officer in defending (whether successfully or otherwise) any civil proceedings concerning our company or its affairs in any court whether in the Cayman Islands or elsewhere.
In addition, we have entered into indemnification agreements with our directors and executive officers that provide such persons with additional
|
| |
A corporation has the power to indemnify any director, officer, employee, or agent of the corporation who was, is or is threatened to be made a party to an action, suit or proceeding who acted in good faith and in a manner they believed to be in the best interests of the corporation, and if with respect to a criminal proceeding, had no reasonable cause to believe his or her conduct would be unlawful, against amounts actually and reasonably incurred. Additionally, under the Delaware General Corporation Law, a Delaware corporation must indemnify its present or former directors and officers against expenses (including attorneys’ fees) actually and reasonably incurred to the extent that the officer or director has been successful on the merits or otherwise in defense of any action, suit or proceeding brought against him or her by reason of the fact that he or she is or was a director or officer of the corporation.
|
|
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| | | | |
indemnification beyond that provided in the Articles.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers or persons controlling us under the foregoing provisions, we have been informed that in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
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| | | |
| |
Directors’ Fiduciary Duties
|
| |
As a matter of Cayman Islands law, a director of a Cayman Islands company is in the position of a fiduciary with respect to the company and therefore it is considered that he owes the following duties to the company — a duty to act in good faith in the best interests of the company, a duty not to make a personal profit based on his position as director (unless the company permits him to do so), a duty not to put himself in a position where the interests of the company conflict with his personal interest or his duty to a third party and a duty to exercise powers for the purpose for which such powers were intended. A director of a Cayman Islands company owes to the company a duty to act with skill and care. It was previously considered that a director need not exhibit in the performance of his duties a greater degree of skill than may reasonably be expected from a person of his knowledge and experience. However, English and Commonwealth courts have moved toward an objective standard with regard to the required skill and care and these authorities are likely to be followed in the Cayman Islands.
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| |
Under Delaware corporate law, a director of a Delaware corporation has a fiduciary duty to the corporation and its shareholders. This duty has two components: the duty of care and the duty of loyalty. The duty of care requires that a director act in good faith, with the care that an ordinarily prudent person would exercise under similar circumstances. Under this duty, a director must inform himself of, and disclose to shareholders, all material information reasonably available regarding a significant transaction.
The duty of loyalty requires that a director acts in a manner he reasonably believes to be in the best interests of the corporation. He must not use his corporate position for personal gain or advantage. This duty prohibits self-dealing by a director and mandates that the best interest of the corporation and its shareholders take precedence over any interest possessed by a director, officer or controlling shareholder and not shared by the shareholders generally.
In general, actions of a director are presumed to have been made on an informed basis, in good faith and in the honest belief that the action taken was in the best interests of the corporation. However, this presumption may be rebutted by evidence of a breach of one of the fiduciary duties. Should such evidence be presented concerning a transaction by a director, the director must prove the procedural fairness of the transaction, and that the transaction was of fair value to the corporation.
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|
| |
Shareholder Action by Written
|
| |
Cayman Islands law and our Amended and Restated Memorandum and Articles of Association provide that our shareholders
|
| |
Under the Delaware General Corporation Law, a corporation may eliminate the right of shareholders to act by written consent
|
|
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| |
Consent
|
| |
may approve corporate matters by way of a unanimous written resolution signed by or on behalf of each shareholder who would have been entitled to vote on such matter at a general meeting without a meeting being held.
|
| |
by amendment to its certificate of incorporation.
|
|
| |
Shareholder Proposals
|
| |
The Companies Act provides shareholders with only limited rights to requisition a general meeting, and does not provide shareholders with any right to put any proposal before a general meeting. However, these rights may be provided in a company’s articles of association. However, the Articles do not contain such rights. As a Cayman Islands exempted company, we are not obliged by law to call shareholders’ annual general meetings.
|
| |
Under the Delaware General Corporation Law, a shareholder has the right to put any proposal before the annual meeting of shareholders; provided that it complies with the notice provisions in the governing documents. A special meeting may be called by the board of directors or any other person authorized to do so in the governing documents, but shareholders may be precluded from calling special meetings.
|
|
| |
Cumulative Voting
|
| |
Cumulative voting potentially facilitates the representation of minority shareholders on a board of directors since it permits the minority shareholder to cast all the votes to which the shareholder is entitled on a single director, which increases the shareholder’s voting power with respect to electing such director. There are no prohibitions in relation to cumulative voting under the laws of the Cayman Islands, but our Amended and Restated Memorandum and Articles of Association do not provide for cumulative voting. As a result, our shareholders are not afforded any less protections or rights on this issue than shareholders of a Delaware corporation.
|
| |
Under the Delaware General Corporation Law, cumulative voting for elections of directors is not permitted unless the corporation’s certificate of incorporation specifically provides for it.
|
|
| |
Removal of Directors
|
| |
Under our Articles, a director (other than the Sponsor Director and any of the Betters Directors) may be removed by way of an ordinary resolution of shareholders at any time before the expiration of his period of office notwithstanding anything in the Articles or in any agreement between Baird Medical and such director. Notwithstanding the foregoing, the Sponsor Director may be removed by the Sponsor and the Betters Directors may be removed by Betters Medical (or its affiliates), in each case, by written notice to Baird Medical. A vacancy on the board created by the removal of a director pursuant to the above may be filled by the election or appointment by ordinary resolution of shareholders at the meeting at which such director is removed or by the affirmative vote of a simple majority of the
|
| |
Under the Delaware General Corporation Law, a director of a corporation with a classified board may be removed only for cause with the approval of a majority of the issued and outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise.
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|
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| | | | |
remaining directors present and voting at a board meeting provided, that in the case of the removal of the Sponsor Director or any of the Betters Directors, the Sponsor and/or Betters Medical (or its affiliates) shall solely be entitled to appoint another person as the Sponsor Director or the Betters Director. Under the Articles, a director’s office shall be vacated if the director (i) becomes bankrupt or has a receiving order made against him or suspends payment or compounds with his creditors; (ii) is found to be or becomes of unsound mind or dies; (iii) resigns his office by notice in writing to Baird Medical; (iv) other than the Sponsor Director or any of the Betters Directors, without special leave of absence from the board of directors, is absent from three consecutive meetings of the board and the board resolves that his office be vacated; (v) is prohibited by law from being a director or; (vi) is removed from office pursuant to the laws of the Cayman Islands or any other provisions of the Articles.
|
| | | |
| |
Transactions with Interested Shareholders
|
| |
Cayman Islands law has no comparable statute. As a result, we cannot avail ourselves of the types of protections afforded by the Delaware business combination statute. However, although Cayman Islands law does not regulate transactions between a company and its significant shareholders, the directors of our company are required to comply with fiduciary duties which they owe to our company under Cayman Islands laws, including the duty to ensure that, in their opinion, any such transactions must be entered into bona fide in the best interests of the company and not with the effect of constituting a fraud on the minority shareholders.
|
| |
The Delaware General Corporation Law contains a business combination statute applicable to Delaware corporations whereby, unless the corporation has specifically elected not to be governed by such statute by amendment to its certificate of incorporation, it is prohibited from engaging in certain business combinations with an “interested shareholder” for three years following the date that such person becomes an interested shareholder. An interested shareholder generally is a person or a group who or which owns or owned 15% or more of the target’s outstanding voting shares within the past three years. This has the effect of limiting the ability of a potential acquirer to make a two-tiered bid for the target in which all shareholders would not be treated equally. The statute does not apply if, among other things, prior to the date on which such shareholder becomes an interested shareholder, the board of directors approves either the business combination or the transaction which resulted in the person becoming an interested shareholder. This encourages any potential acquirer of a Delaware corporation to negotiate the terms of any acquisition transaction with
|
|
| | | | |
Cayman Islands
|
| |
Delaware
|
|
| | | | | | | | the target’s board of directors. | |
| |
Dissolution; Winding Up
|
| |
Under Cayman Islands law, a company may be wound up by either an order of the courts of the Cayman Islands or by a special resolution of its members or, if the company is unable to pay its debts as they fall due, by an ordinary resolution of its members. The court has authority to order winding up in a number of specified circumstances including where it is, in the opinion of the court, just and equitable to do so.
|
| |
Under the Delaware General Corporation Law, unless the board of directors approves the proposal to dissolve, dissolution must be approved by shareholders holding 100% of the total voting power of the corporation. Only if the dissolution is initiated by the board of directors may it be approved by a simple majority of the corporation’s outstanding shares. Delaware law allows a Delaware corporation to include in its certificate of incorporation a supermajority voting requirement in connection with dissolutions initiated by either an order of the courts of the Cayman Islands or by the board of directors.
|
|
| |
Variation of Rights of Shares
|
| |
Under the Articles, if our share capital is divided into more than one class of shares, the rights attached to any such class may only be varied with the sanction of a resolution passed by a majority of two-thirds of the votes cast at a separate meeting of the holders of the shares of that class.
|
| |
Under the Delaware General Corporation Law, a corporation may vary the rights of a class of shares with the approval of a majority of the outstanding shares of such class, unless the certificate of incorporation provides otherwise.
|
|
| |
Amendment of Governing Documents
|
| |
Under the Companies Act and our Amended and Restated Memorandum and Articles of Association, our memorandum and articles of association may only be amended by a special resolution of our shareholders.
|
| |
Under the Delaware General Corporation Law, a corporation’s governing documents may be amended with the approval of a majority of the outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise.
|
|
| |
Rights of Non-resident or Foreign Shareholders
|
| |
There are no limitations imposed by our Amended and Restated Memorandum and Articles of Association on the rights of non-resident or foreign shareholders to hold or exercise voting rights on our shares. In addition, there are no provisions in our Amended and Restated Memorandum and Articles of Association that require our company to disclose shareholder ownership above any particular ownership threshold.
|
| |
Under Delaware General Corporation Law, there are no restrictions on foreign shareholders, and all the stock or membership interests in a Delaware company can be owned by non-U.S. nationals.
|
|
| |
SEC registration fee
|
| | | $ | 36,568 | | |
| |
FINRA filing fee
|
| | | | — | | |
| |
Legal fees and expenses
|
| | | | 45,000 | | |
| |
Accountants’ fees and expenses
|
| | | | 150,000 | | |
| |
Printing expenses
|
| | | | 3,000 | | |
| |
Transfer agent fees and expenses
|
| | | | 1,000 | | |
| |
Miscellaneous costs
|
| | | | 10,000 | | |
| |
Total
|
| | | $ | 245,568 | | |
| | | |
Page
|
| |||
| Baird Medical Investment Holdings Limited | | | | | | | |
|
Unaudited Interim Condensed Consolidated Balance Sheets as of December 31, 2024 and June 30, 2025
|
| | | | F-2 | | |
|
Unaudited Interim Condensed Consolidated Statements of Operations and Comprehensive Income/ Loss for the six months ended June 30, 2024 and 2025
|
| | | | F-3 | | |
|
Unaudited Interim Condensed Consolidated Statements of Changes in Shareholders’ equity for the
six months ended June 30, 2024 and 2025 |
| | | | F-4 | | |
|
Unaudited Interim Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2025
|
| | | | F-5 | | |
|
Notes to the Unaudited Interim Condensed Consolidated Financial Statements
|
| | | | F-6 | | |
| Baird Medical Investment Holdings Limited | | | | | | | |
|
Report of Independent Registered Public Accounting Firm PCAOB ID Number 6651
|
| | | | F-43 | | |
|
Report of Independent Registered Public Accounting Firm PCAOB ID Number 5395
|
| | | | F-44 | | |
|
Consolidated Balance Sheets as of December 31, 2024 and 2023
|
| | | | F-45 | | |
|
Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, 2024, 2023 and 2022
|
| | | | F-46 | | |
|
Consolidated Statements of Changes in Equity for the Years Ended December 31, 2024, 2023 and 2022
|
| | | | F-47 | | |
|
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024, 2023 and 2022
|
| | | | F-48 | | |
|
Notes to the Consolidated Financial Statements
|
| | | | F-49 | | |
(All amounts in U.S. dollars, except for share data, or otherwise noted)
| | | |
As of
|
| |||||||||
| | | |
December 31, 2024
|
| |
June 30, 2025
|
| ||||||
| ASSETS | | | | | | | | | | | | | |
| CURRENT ASSETS | | | | | | | | | | | | | |
|
Cash
|
| | | $ | 2,970,199 | | | | | $ | 2,171,492 | | |
|
Accounts receivable, net
|
| | | | 46,575,776 | | | | | | 40,824,995 | | |
|
Inventories
|
| | | | 1,296,577 | | | | | | 1,430,376 | | |
|
Prepayments, net
|
| | | | 10,274,207 | | | | | | 15,983,806 | | |
|
Deposits and other assets, net
|
| | | | 295,754 | | | | | | 332,689 | | |
|
Due from related parties
|
| | | | 2,862 | | | | | | 2,916 | | |
|
Total Current Assets
|
| | | | 61,415,375 | | | | | | 60,746,274 | | |
| NON-CURRENT ASSETS | | | | | | | | | | | | | |
|
Property and equipment, net
|
| | | | 7,141,064 | | | | | | 6,705,182 | | |
|
Intangible assets, net
|
| | | | 16,528 | | | | | | 12,631 | | |
|
Deferred tax assets
|
| | | | 714,461 | | | | | | 700,524 | | |
|
Right-of-use assets
|
| | | | 475,119 | | | | | | 289,395 | | |
|
Goodwill
|
| | | | 57,772 | | | | | | 58,869 | | |
|
Prepayments – non current
|
| | | | 8,021,046 | | | | | | 8,353,796 | | |
|
Deposits and other assets – non current
|
| | | | 121,505 | | | | | | 123,811 | | |
|
Total Non-Current Assets
|
| | | | 16,547,495 | | | | | | 16,244,208 | | |
|
Total Assets
|
| | | $ | 77,962,870 | | | | | $ | 76,990,482 | | |
| CURRENT LIABILITIES | | | | | | | | | | | | | |
|
Short-term bank loans
|
| | | | 16,166,000 | | | | | | 13,953,020 | | |
|
Tax payables
|
| | | | 2,873,453 | | | | | | 2,452,315 | | |
|
Salaries and benefits payable
|
| | | | 797,912 | | | | | | 693,309 | | |
|
Contract liability
|
| | | | 792,102 | | | | | | 1,093,434 | | |
|
Short-term lease liabilities
|
| | | | 264,316 | | | | | | 118,607 | | |
|
Accounts payable
|
| | | | 1,252,667 | | | | | | 2,136,075 | | |
|
Amounts due to a related party
|
| | | | 3,703,700 | | | | | | 4,502,547 | | |
|
Accrued listing expenses payable
|
| | | | 5,341,848 | | | | | | 5,282,105 | | |
|
Accrued expenses and other payables
|
| | | | 2,518,175 | | | | | | 2,623,151 | | |
|
Deferred tax liabilities
|
| | | | 45,238 | | | | | | 21,559 | | |
|
Long-term loan – current portion
|
| | | | 867,772 | | | | | | 2,591,659 | | |
|
Total Current Liabilities
|
| | | | 34,623,183 | | | | | | 35,467,781 | | |
| NON-CURRENT LIABILITIES | | | | | | | | | | | | | |
|
Long-term lease liabilities
|
| | | | 136,683 | | | | | | 84,459 | | |
|
Long-term loan – non current
|
| | | | 3,442,526 | | | | | | 5,814,171 | | |
|
Total Non-Current Liabilities
|
| | | | 3,579,209 | | | | | | 5,898,630 | | |
|
Total Liabilities
|
| | | $ | 38,202,392 | | | | | $ | 41,366,411 | | |
| Commitments and Contingencies | | | | | | | | | | | | | |
| Equity | | | | | | | | | | | | | |
|
Preferred shares, $0.0001 par value; 5,000,000 shares authorized; 290,000 shares issued and outstanding as of December 31, 2024 and June 30, 2025
|
| | | | 29 | | | | | | 29 | | |
|
Ordinary shares, $0.0001 par value; 500,000,000 shares authorized; 35,728,625 shares issued,25,555,096 shares outstanding as of December 31, 2024; 40,979,382 shares issued, 26,552,370 shares outstanding as of June 30, 2025*
|
| | | | 2,556 | | | | | | 2,655 | | |
|
Additional paid-in capital*
|
| | | | 11,441,712 | | | | | | 17,770,394 | | |
|
Statutory reserve
|
| | | | 4,591,151 | | | | | | 4,611,287 | | |
|
Retained earnings
|
| | | | 26,764,751 | | | | | | 15,450,720 | | |
|
Accumulated other comprehensive loss
|
| | | | (3,141,061) | | | | | | (2,247,122) | | |
|
Total Baird Medical Investment Holdings Limited’s Shareholders’ Equity
|
| | | | 39,659,138 | | | | | | 35,587,963 | | |
|
Non-controlling interests
|
| | | | 101,340 | | | | | | 36,108 | | |
|
Total Equity
|
| | | | 39,760,478 | | | | | | 35,624,071 | | |
|
Total Liabilities and Equity
|
| | | $ | 77,962,870 | | | | | $ | 76,990,482 | | |
COMPREHENSIVE INCOME/LOSS
(All amounts in U.S. dollars, except for share and per share data, or otherwise noted)
| | | |
For the six months ended June 30,
|
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Revenues
|
| | | $ | 13,136,588 | | | | | $ | 7,959,494 | | |
|
Cost of revenues
|
| | | | (1,645,559) | | | | | | (1,424,240) | | |
|
Gross profit
|
| | | | 11,491,029 | | | | | | 6,535,254 | | |
| Operating expenses: | | | | | | | | | | | | | |
|
Selling and marketing expenses
|
| | | | (1,168,576) | | | | | | (1,127,725) | | |
|
General and administrative expenses
|
| | | | (3,205,845) | | | | | | (8,677,640) | | |
|
Research and development expenses
|
| | | | (2,027,439) | | | | | | (7,180,293) | | |
|
Total operating expenses
|
| | | | (6,401,860) | | | | | | (16,985,658) | | |
|
Income from operations
|
| | | | 5,089,169 | | | | | | (10,450,404) | | |
|
Interest expense
|
| | | | (238,919) | | | | | | (358,215) | | |
|
Interest income
|
| | | | 264 | | | | | | 762 | | |
|
Subsidy income
|
| | | | 265 | | | | | | 56,968 | | |
|
Other expenses, net
|
| | | | 5,627 | | | | | | (49,107) | | |
|
Income/(loss) before income tax
|
| | | | 4,856,406 | | | | | | (10,799,996) | | |
|
Income tax provision
|
| | | | (481,279) | | | | | | (559,131) | | |
|
Net income/(loss)
|
| | | | 4,375,127 | | | | | | (11,359,127) | | |
|
Less: Net income/(loss) attributable to non-controlling interests
|
| | | | (44,860) | | | | | | (65,232) | | |
|
Net income/(loss) attributable to Baird Medical Investment Holdings Limited’s
shareholders |
| | | | 4,330,267 | | | | | | (11,293,895) | | |
| Other comprehensive loss | | | | | | | | | | | | | |
|
Foreign currency translation adjustment
|
| | | | (828,730) | | | | | | 893,939 | | |
|
Total comprehensive income/(loss)
|
| | | | 3,546,397 | | | | | | (10,465,188) | | |
|
Non-controlling interests
|
| | | | (44,860) | | | | | | (65,232) | | |
|
Comprehensive income/(loss) attributable to Baird Medical Investment Holdings Limited’s shareholders
|
| | | $ | 3,501,537 | | | | | $ | (10,399,956) | | |
|
Net income/(loss) per share, basic*
|
| | | $ | 0.17 | | | | | $ | (0.43) | | |
|
Net income/(loss) per share, diluted*
|
| | | $ | 0.17 | | | | | $ | (0.43) | | |
|
Weighted average number of shares-basic*
|
| | | | 25,555,096 | | | | | | 26,402,382 | | |
|
Weighted average number of shares-diluted*
|
| | | | 25,555,096 | | | | | | 26,402,382 | | |
| Stock-based compensation expenses included in | | | | | | | | | | | | | |
|
General and administrative expenses
|
| | | $ | — | | | | | $ | (6,328,781) | | |
CHANGES IN SHAREHOLDERS’ EQUITY
(In U.S. dollars, except for share data, or otherwise noted)
| | | |
Preferred shares
|
| |
Ordinary shares*
|
| |
Additional
paid-in capital* |
| |
Statutory
reserve |
| |
Retained
earnings |
| |
Accumulated
other comprehensive loss |
| |
Total
shareholder’s equity |
| |
Non-
controlling interests |
| |
Total
equity |
| |||||||||||||||||||||||||||||||||||||||
| | | |
Shares
|
| |
Amounts
|
| |
Shares
|
| |
Amounts
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Balance at December 31, 2023
|
| | | | — | | | | | | — | | | | | | 25,555,096 | | | | | $ | 2,556 | | | | | $ | 18,850,677 | | | | | $ | 4,508,366 | | | | | $ | 14,394,167 | | | | | $ | (2,005,122) | | | | | $ | 35,750,644 | | | | | $ | (43,389) | | | | | $ | 35,707,255 | | |
|
Net income
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 4,330,267 | | | | | | — | | | | | | 4,330,267 | | | | | | 44,860 | | | | | | 4,375,127 | | |
|
Appropriation of statutory
reserve |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 48,785 | | | | | | (48,785) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Foreign currency translation adjustment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (828,730) | | | | | | (828,730) | | | | | | — | | | | | | (828,730) | | |
|
Balance at June 30, 2024
|
| | | | — | | | | | | — | | | | | | 25,555,096 | | | | | $ | 2,556 | | | | | $ | 18,850,677 | | | | | $ | 4,557,151 | | | | | $ | 18,675,649 | | | | | $ | (2,833,852) | | | | | $ | 39,252,181 | | | | | $ | 1,471 | | | | | $ | 39,253,652 | | |
| | | |
Preferred shares
|
| |
Ordinary shares*
|
| |
Additional
paid-in earnings |
| |
Statutory
reserve |
| |
Retained
earnings |
| |
Accumulated
other comprehensive loss |
| |
Total
shareholder’s equity |
| |
Non-
controlling interests |
| |
Total
equity |
| |||||||||||||||||||||||||||||||||||||||
| | | |
Shares
|
| |
Amounts
|
| |
Shares
|
| |
Amounts
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Balance at December 31,
2024 |
| | | | 290,000 | | | | | $ | 29 | | | | | | 25,555,096 | | | | | $ | 2,556 | | | | | $ | 11,441,712 | | | | | $ | 4,591,151 | | | | | $ | 26,764,751 | | | | | $ | (3,141,061) | | | | | $ | 39,659,138 | | | | | $ | 101,340 | | | | | $ | 39,760,478 | | |
|
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (11,293,895) | | | | | | — | | | | | | (11,293,895) | | | | | | (65,232) | | | | | | (11,359,127) | | |
|
Stock-based compensation to individuals
|
| | | | — | | | | | | — | | | | | | 363,745 | | | | | | 36 | | | | | | 2,134,783 | | | | | | — | | | | | | — | | | | | | — | | | | | | 2,134,783 | | | | | | — | | | | | | 2,134,819 | | |
|
Share issuance to third-party companies
|
| | | | — | | | | | | — | | | | | | 633,529 | | | | | | 63 | | | | | | 4,193,899 | | | | | | — | | | | | | — | | | | | | — | | | | | | 4,193,899 | | | | | | — | | | | | | 4,193,962 | | |
|
Appropriation of statutory reserve
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 20,136 | | | | | | (20,136) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Foreign currency translation adjustment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 893,939 | | | | | | 893,939 | | | | | | — | | | | | | 893,939 | | |
|
Balance at June 30, 2025
|
| | | | 290,000 | | | | | $ | 29 | | | | | | 26,552,370 | | | | | $ | 2,655 | | | | | $ | 17,770,394 | | | | | $ | 4,611,287 | | | | | $ | 15,450,720 | | | | | $ | (2,247,122) | | | | | $ | 35,587,963 | | | | | $ | 36,108 | | | | | $ | 35,624,071 | | |
(In U.S. dollars, except for share data, or otherwise noted)
| | | |
For the six months ended June 30,
|
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | | | | | | | | | | | | | |
|
Net income/(loss)
|
| | | $ | 4,375,127 | | | | | $ | (11,359,127) | | |
|
Adjustments to reconcile net income to net cash (used in)/provided by operating activities:
|
| | | | | | | | | | | | |
|
Depreciation and amortization
|
| | | | 592,743 | | | | | | 597,562 | | |
|
Deferred tax expense
|
| | | | 17,212 | | | | | | 2,922 | | |
|
Stock-based compensation
|
| | | | — | | | | | | 6,328,781 | | |
|
Amortization of right-of-use assets
|
| | | | 181,219 | | | | | | 192,370 | | |
|
Changes in assets and liabilities:
|
| | | | | | | | | | | | |
|
Accounts receivable
|
| | | | (4,139,051) | | | | | | 6,554,286 | | |
|
Inventories
|
| | | | (2,214) | | | | | | (107,862) | | |
|
Prepayments
|
| | | | (4,044,770) | | | | | | (5,610,132) | | |
|
Deposits and other assets
|
| | | | (10,655) | | | | | | (30,941) | | |
|
Accounts payable
|
| | | | 5,702 | | | | | | 849,167 | | |
|
Contract liabilities
|
| | | | 51,274 | | | | | | 282,814 | | |
|
Lease liabilities
|
| | | | (299,861) | | | | | | (203,040) | | |
|
Accrued expenses and other payables
|
| | | | (141,643) | | | | | | (220,957) | | |
|
Taxes payable
|
| | | | (545,480) | | | | | | (469,878) | | |
|
Net cash used in operating activities
|
| | | | (3,960,397) | | | | | | (3,194,035) | | |
| CASH FLOWS FROM INVESTING ACTIVITIES: | | | | | | | | | | | | | |
|
Purchase of property and equipment
|
| | | | (484,839) | | | | | | (44,610) | | |
|
Net cash used in investing activities
|
| | | | (484,839) | | | | | | (44,610) | | |
| CASH FLOWS FROM FINANCING ACTIVITIES: | | | | | | | | | | | | | |
|
Proceeds from short-term bank loans
|
| | | | 8,454,600 | | | | | | 9,646,105 | | |
|
Repayments of short-term bank loans
|
| | | | (3,465,000) | | | | | | (12,135,200) | | |
|
Proceeds from long-term loan
|
| | | | — | | | | | | 4,963,986 | | |
|
Payment of long-term loan
|
| | | | (393,601) | | | | | | (999,133) | | |
|
Due to a related party
|
| | | | (8,433) | | | | | | 719,685 | | |
|
Payment of listing cost
|
| | | | (130,349) | | | | | | — | | |
|
Net cash provided by financing activities
|
| | | | 4,457,217 | | | | | | 2,195,443 | | |
|
Effect of exchange rate changes
|
| | | | (20,051) | | | | | | 244,495 | | |
|
Net change in cash
|
| | | | (8,070) | | | | | | (798,707) | | |
|
Cash at beginning of the period
|
| | | $ | 1,510,484 | | | | | $ | 2,970,199 | | |
|
Cash at end of the period
|
| | | $ | 1,502,414 | | | | | $ | 2,171,492 | | |
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | | | | | | | | | | | | | |
|
Cash paid for income taxes
|
| | | $ | 919,829 | | | | | $ | 632,467 | | |
|
Cash paid for interest
|
| | | $ | 238,919 | | | | | $ | 358,215 | | |
| SUPPLEMENTAL DISCLOSURE OF NONCASH FLOW INFORMATION: | | | | | | | | | | | | | |
|
Stock-based compensation
|
| | | $ | — | | | | | $ | 6,328,781 | | |
(In U.S. dollars, except for share data, or otherwise noted)
|
Name of Entity
|
| |
Date of
Incorporation/ Acquisition |
| |
Place of
Incorporation |
| |
Shareholders
|
| |
% of
Equity Ownership |
| |
Principal Activities
|
|
| Betters Medical NewCo, LLC (“NewCo”) | | |
June 17, 2024 / October 1,
2024 |
| |
Delaware (US)
|
| |
PubCo
|
| |
100%
|
| |
Holding
|
|
| ExcelFin Acquisition Corp. (“SPAC” or “ExcelFin”) | | |
March 15,
2021 / October 1, 2024 |
| |
Delaware (US)
|
| |
PubCo
|
| |
100%
|
| |
Holding
|
|
| Baird Medical LLC | | |
November 29,
2023 |
| |
Delaware (US)
|
| |
PubCo
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Tycoon Choice Global Limited (“Tycoon”) | | |
January 8,
2021 |
| |
BVI
|
| |
PubCo
|
| |
100%
|
| |
Holding
|
|
| Baide Medical Investment Company Limited (“Baide HK”) | | |
January 29,
2021 |
| |
Hong Kong
|
| |
Tycoon
|
| |
100%
|
| |
Holding
|
|
| Baide (Guangdong) Capital Management Company Limited (“Baide Capital”) | | |
March 3,
2021 |
| |
The PRC
|
| |
Baide HK
|
| |
100%
|
| |
Sales of MWA
medical devices and investment holding |
|
| Guangzhou Dedao Capital Management Company Limited (“Dedao”) | | |
March 4,
2021 |
| |
The PRC
|
| |
Baide Capital
|
| |
99%
|
| |
Holding
|
|
| Guangzhou Baihui Corporate Management Company Limited (“Baihui”) | | |
December 4,
2020 |
| |
The PRC
|
| |
Dedao
|
| |
99%
|
| |
Holding
|
|
| Guangzhou Zhengde Corporate Management Company Limited | | |
December 4,
2020 |
| |
The PRC
|
| |
Dedao
|
| |
99%
|
| |
Holding
|
|
| Guangzhou Yide Capital Management Company Limited | | |
December 10,
2020 |
| |
The PRC
|
| |
Dedao
|
| |
99%
|
| |
Holding
|
|
| Baide (Suzhou) Medical Company Limited (“Baide Suzhou”) | | |
June 5,
2012 |
| |
The PRC
|
| |
Zhengde Yide,
and Baihui |
| |
99%
|
| |
Research and
development, sales of MWA and other medical devices and investment holding |
|
| Henan Ruide Medical Instrument Company Limited | | |
July 6,
2018 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA and
other medical devices |
|
| Nanjing Changcheng Medical Equipment Company Limited (“Nanjing Changcheng”) | | |
January 28,
2016 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Research and
development, manufacture and sales of MWA and other medical devices |
|
| Guizhou Baiyuan Medical Company Limited | | |
September 21,
2017 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of other
medical devices |
|
|
Name of Entity
|
| |
Date of
Incorporation/ Acquisition |
| |
Place of
Incorporation |
| |
Shareholders
|
| |
% of
Equity Ownership |
| |
Principal Activities
|
|
| Guoke Baide (Guangdong) Medical Company Limited (“Guoke Baide”) | | |
July 5, 2019
|
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Hunan Baide Medical Technology Company Limited | | |
November 26,
2019 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Ruikede Biological Technology (Xiamen) Company Limited (“Ruikede Xiamen”) | | |
July 17, 2019
|
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Guangzhou Fangda Medical Technology Company Limited | | |
December 22,
2022 |
| |
The PRC
|
| |
Baide Capital
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Junde (Guangzhou) Medical Technology Company Limited | | |
November 14,
2022 |
| |
The PRC
|
| |
Guoke Baide
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Shengde (Guangzhou) Medical Technology Company Limited | | |
November 29,
2022 |
| |
The PRC
|
| |
Baide Capital
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Suzhou Kangchuang Medical Company Limited | | |
December 6,
2022 |
| |
The PRC
|
| |
Baide Capital
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Hainan Haike Baide Medical Company Limited | | |
July 4, 2024
|
| |
The PRC
|
| |
Baide Suzhou
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| | | |
Useful life
|
|
| Machinery | | | 3 – 10 years | |
| Furniture, fixtures and equipment | | | 3 – 5 years | |
| Vehicles | | | 4 years | |
| Medical equipment | | | 6 – 10 years | |
| Leasehold improvement | | | Over the lease term or estimated useful lives of 5 years, whichever is shorter | |
| | | |
Useful life
|
|
| Patent | | | 6 years | |
| Software | | | 5 years | |
| | | |
Number of
shares |
| |||
|
Baird Medical Investment Holdings Limited’s ordinary shares outstanding at December 31, 2023
|
| | | | 29,411,765 | | |
|
Baird Medical Investment Holdings Limited’s ordinary shares outstanding prior to the Reverse Recapitalization
|
| | | | 29,411,765 | | |
|
Conversion of original Baird Medical Investment Holdings Limited Shareholders ordinary shares
|
| | | | 20,588,236 | | |
|
Conversion of SPAC Sponsor ordinary shares
|
| | | | 4,400,000 | | |
|
Conversion of Working capital loan ordinary shares
|
| | | | 278,406 | | |
|
Conversion of Public Shareholders ordinary shares
|
| | | | 288,454 | | |
|
Total number of ordinary shares as of closing of the Reverse Recapitalization
|
| | | | 25,555,096 | | |
|
Total number of Series A convertible preferred shares as of closing of PIPE transactions
|
| | | | 290,000 | | |
| | | |
For the year
ended December 31, 2024 |
| |||
|
Cash held by ExcelFin and cash related to ExcelFin trust account
|
| | | $ | 9,238,626 | | |
|
Less redemptions
|
| | | | (6,043,240) | | |
|
Cash related to trust account, net of redemptions
|
| | | | 3,195,386 | | |
|
Less cash paid associated with transaction costs allocated to Reverse Recapitalization
|
| | | | (3,116,936) | | |
|
Less cash paid on behalf of the Company for professional expenses
|
| | | | (78,450) | | |
|
Proceeds from PIPE financing – Grand Fortune Capital, LLC
|
| | | | 2,900,000 | | |
|
Less cash payment associated with transaction costs allocated to PIPE
|
| | | | (2,900,000) | | |
|
Net contributions from Reverse Recapitalization and PIPE financing
|
| | | $ | — | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
Accounts receivable
|
| | | $ | 50,568,698 | | | | | $ | 44,893,310 | | |
|
Less: allowance for credit losses
|
| | | | (3,992,922) | | | | | | (4,068,315) | | |
|
Accounts receivable, net
|
| | | $ | 46,575,776 | | | | | $ | 40,824,995 | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Balance at the beginning of the period
|
| | | $ | (2,841,192) | | | | | $ | (3,992,922) | | |
|
Additions charged to allowance for expected credit losses
|
| | | | (636,674) | | | | | | (272,981) | | |
|
Recovery of allowance for expected credit losses
|
| | | | 636,674 | | | | | | 272,981 | | |
|
Foreign currency translation adjustments
|
| | | | 64,572 | | | | | | (75,393) | | |
|
Balance at the end of the period
|
| | | $ | (2,776,620) | | | | | $ | (4,068,315) | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
Not Overdue
|
| | | $ | 13,225,014 | | | | | $ | 5,008,950 | | |
|
Within 90 days
|
| | | | 9,983,041 | | | | | | 1,172,740 | | |
|
Between 3 and 6 months
|
| | | | 7,247,650 | | | | | | 12,210,320 | | |
|
Between 6 months and a year
|
| | | | 11,801,484 | | | | | | 14,579,290 | | |
|
Over a year
|
| | | | 8,311,509 | | | | | | 11,922,010 | | |
| | | | | $ | 50,568,698 | | | | | $ | 44,893,310 | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
Finished goods
|
| | | $ | 717,312 | | | | | $ | 742,279 | | |
|
Raw materials
|
| | | | 348,910 | | | | | | 411,192 | | |
|
Work in progress
|
| | | | 230,355 | | | | | | 276,905 | | |
|
Inventories
|
| | | $ | 1,296,577 | | | | | $ | 1,430,376 | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
Prepayment for R&D
|
| | | $ | 13,296,763 | | | | | $ | 17,340,933 | | |
|
Prepayment for purchase of property and equipment
|
| | | | 1,378,198 | | | | | | 1,360,542 | | |
|
Prepayment for purchase of materials and others
|
| | | | 3,305,963 | | | | | | 4,634,380 | | |
|
Prepaid expense for others
|
| | | | 319,196 | | | | | | 1,006,706 | | |
|
Subtotal
|
| | | | 18,300,120 | | | | | | 24,342,561 | | |
|
Less: impairment loss
|
| | | | (4,867) | | | | | | (4,959) | | |
|
Subtotal, net
|
| | | | 18,295,253 | | | | | | 24,337,602 | | |
|
Less: Long term portion
|
| | | | (8,021,046) | | | | | | (8,353,796) | | |
|
Prepayments, net – current portion
|
| | | $ | 10,274,207 | | | | | $ | 15,983,806 | | |
| | | |
For the six months
ended June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Balance at the beginning of the period
|
| | | $ | (5,002) | | | | | $ | (4,867) | | |
|
Additions charged to the impairment loss
|
| | | | — | | | | | | — | | |
|
Foreign currency translation adjustments
|
| | | | 114 | | | | | | (92) | | |
|
Balance at the end of the period
|
| | | $ | (4,888) | | | | | $ | (4,959) | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30.
2025 |
| ||||||
|
Deposits
|
| | | $ | 185,282 | | | | | $ | 174,907 | | |
|
Other receivables
|
| | | | 341,288 | | | | | | 373,179 | | |
|
Subtotal
|
| | | $ | 526,570 | | | | | $ | 548,086 | | |
|
Less: allowance of credit loss
|
| | | | (109,311) | | | | | | (91,586) | | |
|
Subtotal, net
|
| | | $ | 417,259 | | | | | $ | 456,500 | | |
|
Less: Long term portion
|
| | | | (121,505) | | | | | | (123,811) | | |
|
Deposits and other assets- current portion
|
| | | $ | 295,754 | | | | | $ | 332,689 | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Balance at the beginning
|
| | | $ | (112,343) | | | | | $ | (109,311) | | |
|
Recovery and write off of allowance for expected credit losses
|
| | | | — | | | | | | 19,800 | | |
|
Foreign currency translation adjustments
|
| | | | 2,553 | | | | | | (2,075) | | |
|
Balance at the end
|
| | | $ | (109,790) | | | | | $ | (91,586) | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
Leasehold improvement
|
| | | $ | 4,327,441 | | | | | $ | 4,436,657 | | |
|
Machinery
|
| | | | 6,600,001 | | | | | | 6,727,480 | | |
|
Furniture, fixtures and equipment
|
| | | | 435,052 | | | | | | 443,309 | | |
|
Motor vehicles
|
| | | | 41,184 | | | | | | 41,965 | | |
|
Medical equipment
|
| | | | 331,960 | | | | | | 338,260 | | |
|
Total
|
| | | | 11,735,638 | | | | | | 11,987,671 | | |
|
Less: Accumulated depreciation
|
| | | | (4,594,574) | | | | | | (5,282,489) | | |
|
Property and equipment, net
|
| | | $ | 7,141,064 | | | | | $ | 6,705,182 | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
Patent
|
| | | $ | 246,600 | | | | | $ | 251,280 | | |
|
Software
|
| | | | 41,319 | | | | | | 42,103 | | |
|
Less: accumulated amortization
|
| | | | (271,391) | | | | | | (280,752) | | |
|
Intangible assets, net
|
| | | $ | 16,528 | | | | | $ | 12,631 | | |
|
Years ending December 31,
|
| |
Amortization
expense |
| |||
|
2025
|
| | | | 4,210 | | |
|
2026
|
| | | | 8,421 | | |
|
Total
|
| | | $ | 12,631 | | |
|
Lender
|
| |
Company
|
| |
Guarantors/
Collateral |
| |
Effective
Interest Rate |
| |
Issuance
Date |
| |
Expiration
Date |
| |
Amount-
RMB |
| |
Amount-
US$ |
|
| Nanjing Bank Jiangning Branch | | | Baide Suzhou | | | N/A | | |
3.60%
|
| |
February 24, 2025
|
| |
February 10, 2026
|
| |
4,950,000
|
| |
691,020
|
|
| Industrial and Commercial Bank of China | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.01%
|
| | March 18, 2025 | | | March 13, 2026 | | |
10,000,000
|
| |
1,396,000
|
|
| China Merchants Bank | | | Baide Suzhou | | | Baihui | | |
2.55%
|
| | October 31, 2024 | | | October 28, 2025 | | |
5,000,000
|
| |
698,000
|
|
| China Merchants Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
2.55%
|
| |
November 6, 2024
|
| |
November 5, 2025
|
| |
5,000,000
|
| |
698,000
|
|
| Jiangsu Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.30%
|
| |
December 4, 2024
|
| |
December 3, 2025
|
| |
5,000,000
|
| |
698,000
|
|
| Bank of China | | | Baide Suzhou | | |
NanjingChangcheng / Baide capital |
| |
3.10%
|
| |
December 6, 2024
|
| |
December 5, 2025
|
| |
10,000,000
|
| |
1,396,000
|
|
| China CITIC Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.00%
|
| |
December 25, 2024
|
| |
December 25, 2025
|
| |
10,000,000
|
| |
1,396,000
|
|
| China CITIC Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.00%
|
| | June 27, 2025 | | |
December 27, 2025
|
| |
10,000,000
|
| |
1,396,000
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.50%
|
| | March 24, 2025 | | | March 24, 2026 | | |
6,000,000
|
| |
837,600
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.50%
|
| | May 14, 2024 | | | May 14, 2026 | | |
4,000,000
|
| |
558,400
|
|
| Bank of Communications Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
2.80%
|
| | May 22, 2025 | | | May 20, 2026 | | |
10,000,000
|
| |
1,396,000
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
4.05%
|
| | August 26, 2024 | | | August 19, 2025 | | |
2,000,000
|
| |
279,200
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.85%
|
| |
November 21, 2024
|
| | November 19,2025 | | |
3,000,000
|
| |
418,800
|
|
| Bank of China | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
2.80%
|
| | June 12, 2025 | | | June 11, 2026 | | |
10,000,000
|
| |
1,396,000
|
|
| Hangzhou Bank | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.50%
|
| |
February 26, 2025
|
| |
February 25, 2026
|
| |
5,000,000
|
| |
698,000
|
|
| Total | | | | | | | | | | | | | | | | | |
99,950,000
|
| |
13,953,020
|
|
|
Lender
|
| |
Company
|
| |
Guarantors/
Collateral |
| |
Effective
Interest Rate |
| |
Issuance
Date |
| |
Expiration
Date |
| |
Amount-
RMB |
| |
Amount-
US$ |
|
|
Industrial and Commercial Bank of China
|
| | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.00%
|
| | January 12, 2024 | | | January 11,2025 | | |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | | Baihui | | |
2.55%
|
| |
September 13, 2024
|
| | March 13, 2025 | | |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.00%
|
| |
November 11, 2024
|
| | March 26, 2025 | | |
10,000,000
|
| |
1,370,000
|
|
| China Merchants Bank | | | Baide Suzhou | | | Baihui | | |
2.55%
|
| | October 31, 2024 | | | October 28, 2025 | | |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
2.55%
|
| |
November 6, 2024
|
| |
November 5, 2025
|
| |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
2.55%
|
| |
November 7, 2024
|
| | May 5, 2025 | | |
5,000,000
|
| |
685,000
|
|
| Jiangsu Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.30%
|
| |
December 4, 2024
|
| |
December 3, 2025
|
| |
5,000,000
|
| |
685,000
|
|
| Bank of China | | | Baide Suzhou | | |
Nanjing Changcheng / Baide capital |
| |
3.10%
|
| |
December 6, 2024
|
| |
December 5, 2025
|
| |
10,000,000
|
| |
1,370,000
|
|
| China CITIC Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.00%
|
| |
December 25, 2024
|
| |
December 25, 2025
|
| |
10,000,000
|
| |
1,370,000
|
|
| China CITIC Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.00%
|
| |
December 26, 2024
|
| | June 26, 2025 | | |
10,000,000
|
| |
1,370,000
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.95%
|
| | May 14, 2024 | | | May 14, 2025 | | |
4,000,000
|
| |
548,000
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
4.15%
|
| | March 27, 2024 | | | March 27, 2025 | | |
6,000,000
|
| |
822,000
|
|
|
Bank of Communications Suzhou Branch
|
| | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.40%
|
| | May 6, 2024 | | | May 6, 2025 | | |
5,000,000
|
| |
685,000
|
|
|
Bank of Communications Suzhou Branch
|
| | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.40%
|
| | May 11, 2024 | | | May 11, 2025 | | |
5,000,000
|
| |
685,000
|
|
| China Minsheng Bank | | | Baide Suzhou | | | N/A | | |
4.10%
|
| | April 26, 2024 | | | April 25, 2025 | | |
3,000,000
|
| |
411,000
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
4.05%
|
| | August 26, 2024 | | | August 19, 2025 | | |
2,000,000
|
| |
274,000
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.85%
|
| |
November 21, 2024
|
| |
November 19, 2025
|
| |
3,000,000
|
| |
411,000
|
|
| Bank of China | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.36%
|
| |
September 26, 2024
|
| | June 20, 2025 | | |
3,000,000
|
| |
411,000
|
|
| Hangzhou Bank | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.90%
|
| | January 30, 2024 | | | January 29, 2025 | | |
10,000,000
|
| |
1,370,000
|
|
| Bank of China Nanjing Hexi Branch | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.36%
|
| | June 26, 2024 | | | June 20, 2025 | | |
7,000,000
|
| |
959,000
|
|
| Total | | | | | | | | | | | | | | | | | |
118,000,000
|
| |
16,166,000
|
|
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
Financial liabilities
|
| | | $ | 1,570,298 | | | | | $ | 2,961,430 | | |
|
Less: current portions
|
| | | | (867,772) | | | | | | (2,033,259) | | |
|
Long-term Financial liabilities
|
| | | | 702,526 | | | | | | 928,171 | | |
|
Long-term Bank borrowings
|
| | | | 2,740,000 | | | | | | 5,444,400 | | |
|
Less: Long-term Bank borrowings – current portions
|
| | | | — | | | | | | (558,400) | | |
|
Total long-term loan
|
| | | $ | 3,442,526 | | | | | $ | 5,814,171 | | |
|
Lender
|
| |
Company
|
| |
Guarantors/
Collateral |
| |
Effective
Interest Rate |
| |
Issuance
Date |
| |
Expiration
Date |
| |
Amount-
RMB |
| |
Amount-US$
|
|
| Bank of China | | |
Baide Suzhou
|
| |
Nanjing Changcheng /
Baide capital |
| |
3.10%
|
| |
December 18, 2024
|
| |
December 17, 2027
|
| |
19,000,000
|
| |
2,652,400
|
|
| SPD Bank | | |
Baide Suzhou
|
| | N/A | | |
2.90%
|
| | March 31, 2025 | | | March 30, 2028 | | |
10,000,000
|
| |
1,396,000
|
|
| SPD Bank | | |
Baide Suzhou
|
| | N/A | | |
2.90%
|
| | April 14, 2025 | | | March 30, 2028 | | |
10,000,000
|
| |
1,396,000
|
|
| | Years ending December 31, | | | | | | | |
| |
2025 Financial liabilities payment
|
| | | $ | 1,095,552 | | |
| |
2026 Financial liabilities payment
|
| | | | 1,942,021 | | |
| |
2027 Financial liabilities payment
|
| | | | 99,574 | | |
| |
Total Financial liabilities payments
|
| | | $ | 3,137,147 | | |
| |
Less: Financial liabilities imputed interest
|
| | | | (175,717) | | |
| |
Total Financial liabilities payment
|
| | | $ | 2,961,430 | | |
| |
Less: Financial liabilities – long term portions
|
| | | | (928,171) | | |
| |
Financial liabilities payment – current portions
|
| | | $ | 2,033,259 | | |
| |
2025 Long-term Bank borrowings repayment
|
| | | $ | 279,200 | | |
| |
2026 Long-term Bank borrowings repayment
|
| | | | 698,000 | | |
| |
2027 Long-term Bank borrowings repayment
|
| | | | 3,490,000 | | |
| |
2028 Long-term Bank borrowings repayment
|
| | | | 977,200 | | |
| |
Total Long-term Bank borrowings
|
| | | $ | 5,444,400 | | |
| |
Less: Long-term Bank borrowings – long term portions
|
| | | | (4,886,000) | | |
| |
Long-term Bank borrowings – current portions
|
| | | $ | 558,400 | | |
| | | |
For the six months
ended June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Cash payments for operating leases
|
| | | $ | 318,622 | | | | | $ | 211,122 | | |
|
Right-of-use assets obtained in exchange for operating lease liabilities
|
| | | | — | | | | | | — | | |
| | | |
Operating
leases |
| |||
|
2025
|
| | | $ | 57,456 | | |
|
2026
|
| | | | 117,036 | | |
|
2027
|
| | | | 29,998 | | |
|
Total future lease payments
|
| | | $ | 204,490 | | |
|
Less: imputed interest
|
| | | | (1,424) | | |
|
Total lease liabilities
|
| | | $ | 203,066 | | |
|
Less: Long term portions
|
| | | | (84,459) | | |
|
Lease liabilities – current portions
|
| | | $ | 118,607 | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
| | | |
(Unaudited)
|
| |
(Unaudited)
|
| ||||||
|
Current tax expense
|
| | | $ | 464,067 | | | | | $ | 556,208 | | |
|
Deferred tax benefit
|
| | | | 17,212 | | | | | | 2,923 | | |
|
Income tax provision
|
| | | $ | 481,279 | | | | | $ | 559,131 | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
| | | |
(Unaudited)
|
| |
(Unaudited)
|
| ||||||
|
Cayman Islands
|
| | | $ | — | | | | | $ | (4,915,703) | | |
|
United States
|
| | | | — | | | | | | (257,605) | | |
|
Hong Kong
|
| | | | (175,998) | | | | | | 273,663 | | |
|
PRC
|
| | | | 5,032,404 | | | | | | (5,900,351) | | |
| | | | | $ | 4,856,406 | | | | | $ | (10,799,996) | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
| | | |
(Audited)
|
| |
(Unaudited)
|
| ||||||
| Deferred tax assets: | | | | | | | | | | | | | |
|
Allowance for expected credit losses
|
| | | $ | 552,486 | | | | | $ | 559,886 | | |
|
Net operating loss carryforward
|
| | | | 901,272 | | | | | | 953,897 | | |
|
Lease liabilities
|
| | | | 36,118 | | | | | | 11,269 | | |
|
Total deferred tax assets
|
| | | $ | 1,489,876 | | | | | $ | 1,525,052 | | |
|
Less: Valuation allowance
|
| | | | (775,415) | | | | | | (824,528) | | |
|
Deferred tax assets, net
|
| | | $ | 714,461 | | | | | $ | 700,524 | | |
| Deferred tax liabilities: | | | | | | | | | | | | | |
|
Right-of-use assets
|
| | | | 45,238 | | | | | | 21,559 | | |
|
Total deferred tax liabilities
|
| | | $ | 45,238 | | | | | $ | 21,559 | | |
| | | |
June 30, 2024
|
| |
June 30, 2025
|
| ||||||
| | | |
(Unaudited)
|
| |
(Unaudited)
|
| ||||||
|
Beginning balance
|
| | | $ | (441,549) | | | | | $ | (775,415) | | |
|
Increase in valuation allowance
|
| | | | (23,809) | | | | | | (50,045) | | |
|
Foreign exchange
|
| | | | 10,035 | | | | | | 932 | | |
|
Ending balance
|
| | | $ | (455,323) | | | | | $ | (824,528) | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
|
VAT tax payable
|
| | | $ | 358,792 | | | | | $ | 58,267 | | |
|
Income tax payable
|
| | | | 79,167 | | | | | | 4,818 | | |
|
Other tax payables*
|
| | | | 2,435,494 | | | | | | 2,389,230 | | |
|
Total tax payables
|
| | | $ | 2,873,453 | | | | | $ | 2,452,315 | | |
| | | |
Number of
Restricted Shares Granted |
| |
Weighted-Average
Grant Date Fair Value (US$) |
| ||||||
|
Unvested as of January 1, 2025
|
| | | | — | | | | | | — | | |
| Awarded | | | | | 363,745 | | | | | | 5.8690 | | |
| Including: | | | | | | | | | | | | | |
|
Awarded to Directors
|
| | | | 323,745 | | | | | | 5.4313 | | |
|
Awarded to Non-employee consultants
|
| | | | 40,000 | | | | | | 0.4377 | | |
| Vested | | | | | (363,745) | | | | | | (5.8690) | | |
|
Outstanding at June 30, 2025
|
| | | | — | | | | | | — | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
| | | |
(Unaudited)
|
| |
(Unaudited)
|
| ||||||
| Numerator: | | | | | | | | | | | | | |
|
Net income/(loss) attributable to the Company’s ordinary shareholders – basic
|
| | | $ | 4,330,267 | | | | | $ | (11,293,895) | | |
|
Dilution impacts
|
| | | | — | | | | | | — | | |
|
Net income/(loss) attributable to the Company’s ordinary shareholders – diluted
|
| | | | 4,330,267 | | | | | | (11,293,895) | | |
| Denominator: | | | | | | | | | | | | | |
|
Weighted average number of shares – basic
|
| | | | 25,555,096 | | | | | | 26,402,382 | | |
|
Effects of dilutive securities
|
| | | | — | | | | | | — | | |
|
Weighted average number of shares – diluted
|
| | | | 25,555,096 | | | | | | 26,402,382 | | |
|
Net income/(loss) per share, basic
|
| | | $ | 0.17 | | | | | $ | (0.43) | | |
|
Net income/(loss) per share, diluted
|
| | | $ | 0.17 | | | | | $ | (0.43) | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
| Due from related parties: | | | | | | | | | | | | | |
|
Haimei Wu(1)
|
| | | $ | — | | | | | $ | — | | |
|
Betters Medical Investment Holdings Limited
|
| | | | 2,862 | | | | | | 2,916 | | |
|
Total
|
| | | $ | 2,862 | | | | | $ | 2,916 | | |
| Due to related parties: | | | | | | | | | | | | | |
|
Betters Medical Investment Holdings Limited(2)
|
| | | $ | 3,703,700 | | | | | $ | 4,502,547 | | |
|
Total
|
| | | $ | 3,703,700 | | | | | $ | 4,502,547 | | |
| | | |
Payment Due by Period
|
| |||||||||||||||
| | | |
Total
|
| |
Less than
1 Year |
| |
1 – 3 Years
|
| |||||||||
|
Short-term bank loans
|
| | | $ | 13,953,020 | | | | | $ | 13,953,020 | | | | | $ | — | | |
|
Lease payment
|
| | | | 204,490 | | | | | | 115,481 | | | | | | 89,009 | | |
|
Long term loan
|
| | | | 8,405,830 | | | | | | 2,591,659 | | | | | | 5,814,171 | | |
|
Total
|
| | | $ | 22,563,340 | | | | | $ | 16,660,160 | | | | | $ | 5,903,180 | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
| | | |
US$
|
| |
US$
|
| ||||||
|
Revenues
|
| | | $ | 13,136,588 | | | | | $ | 7,959,494 | | |
|
Cost of revenues
|
| | | | (1,645,559) | | | | | | (1,424,240) | | |
|
Gross profit
|
| | | | 11,491,029 | | | | | | 6,535,254 | | |
| Operating expenses: | | | | | | | | | | | | | |
|
Selling and marketing expenses
|
| | | | (1,168,576) | | | | | | (1,127,725) | | |
|
General and administrative expenses
|
| | | | (3,205,845) | | | | | | (8,677,640) | | |
|
Research and development expenses
|
| | | | (2,027,439) | | | | | | (7,180,293) | | |
|
Total operating expenses
|
| | | | (6,401,860) | | | | | | (16,985,658) | | |
|
Income from operations
|
| | | | 5,089,169 | | | | | | (10,450,404) | | |
|
Interest expense
|
| | | | (238,919) | | | | | | (358,215) | | |
|
Interest income
|
| | | | 264 | | | | | | 762 | | |
|
Subsidy income
|
| | | | 265 | | | | | | 56,968 | | |
|
Other expenses, net
|
| | | | 5,627 | | | | | | (49,107) | | |
|
Income before income tax
|
| | | | 4,856,406 | | | | | | (10,799,996) | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Distributors
|
| | | $ | 7,822,407 | | | | | $ | 5,306,016 | | |
|
Direct customers(1)
|
| | | | 5,314,181 | | | | | | 2,653,478 | | |
|
Total
|
| | | $ | 13,136,588 | | | | | $ | 7,959,494 | | |
| | | |
For the years ended
For the six months ended June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
At a point of time
|
| | | $ | 13,136,588 | | | | | $ | 7,959,494 | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
MWA devices
|
| | | $ | 13,128,316 | | | | | $ | 7,958,761 | | |
|
– MWA needles
|
| | | | 11,671,519 | | | | | | 6,539,540 | | |
|
– MWA therapeutic apparatus
|
| | | | 1,456,797 | | | | | | 1,419,221 | | |
|
Other medical devices
|
| | | | 8,272 | | | | | | 733 | | |
|
Total
|
| | | $ | 13,136,588 | | | | | $ | 7,959,494 | | |
| | | |
As of
|
| |||||||||
| | | |
December 31,
2024 |
| |
June 30,
2025 |
| ||||||
| ASSETS | | | | | | | | | | | | | |
|
Amounts due from related parties
|
| | | | 2,941 | | | | | | 2,684 | | |
|
Investments in subsidiaries
|
| | | $ | 39,656,197 | | | | | $ | 35,585,279 | | |
|
Total Assets
|
| | | $ | 39,659,138 | | | | | $ | 35,587,963 | | |
| Shareholders’ Equity | | | | | | | | | | | | | |
|
Preferred shares, $0.0001 par value; 5,000,000 shares authorized; 290,000 shares issued and outstanding as of December 31, 2024 and June 30,
2025 |
| | | | 29 | | | | | | 29 | | |
|
Ordinary shares, $0.0001 par value; 500,000,000 shares authorized; 35,728,625
shares issued, 25,555,096 shares outstanding as of December 31, 2024; 40,979,382 shares issued, 26,552,370 shares outstanding as of June 30, 2025* |
| | | $ | 2,556 | | | | | | 2,655 | | |
|
Additional paid-in capital*
|
| | | | 11,441,712 | | | | | | 17,770,394 | | |
|
Retained earnings
|
| | | | 31,355,902 | | | | | | 20,062,007 | | |
|
Accumulated other comprehensive loss
|
| | | | (3,141,061) | | | | | | (2,247,122) | | |
|
Total Shareholders’ Equity
|
| | | | 39,659,138 | | | | | | 35,587,963 | | |
|
Total Liabilities and Shareholders’ Equity
|
| | | $ | 39,659,138 | | | | | $ | 35,587,963 | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
|
Share of profit/loss in subsidiaries, net (Note a)
|
| | | $ | 4,330,267 | | | | | $ | (11,293,895) | | |
|
Income/(loss) before income tax
|
| | | | 4,330,267 | | | | | | (11,293,895) | | |
|
Income tax provision
|
| | | | — | | | | | | — | | |
|
Net income/(loss)
|
| | | | 4,330,267 | | | | | | (11,293,895) | | |
|
Other comprehensive (loss) income
|
| | | | | | | | | | | | |
|
Foreign currency translation (loss) income
|
| | | $ | (828,730) | | | | | $ | 893,939 | | |
|
Comprehensive income/(loss)
|
| | | $ | 3,501,537 | | | | | $ | (10,399,956) | | |
| | | |
For the six months ended
June 30, |
| |||||||||
| | | |
2024
|
| |
2025
|
| ||||||
| Cash flows from operating activities | | | | | | | | | | | | | |
|
Net income/(loss)
|
| | | $ | 4,330,267 | | | | | $ | (11,293,895) | | |
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
| | | | | | | | | | | | |
|
Equity income/(loss) in subsidiaries
|
| | | | (4,330,267) | | | | | | 11,293,895 | | |
|
Net cash provided by operating activities
|
| | | | — | | | | | | — | | |
|
Cash at beginning of the period
|
| | | $ | — | | | | | | — | | |
|
Cash at the end of the period
|
| | | $ | — | | | | | $ | — | | |
733 Third Avenue, Floor 16, #1014
New York, NY 10017
(949) 326-CPAS (2727)
May 15, 2025
June 20, 2024
Phone 646.442.4845 • Fax 646.349.5200 • www.marcumasia.com
(All amounts in U.S. dollars, except for share and per share data, or otherwise noted)
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
| ASSETS | | | | | | | | | | | | | |
| CURRENT ASSETS | | | | | | | | | | | | | |
|
Cash
|
| | | $ | 2,970,199 | | | | | $ | 1,510,484 | | |
|
Accounts receivable, net
|
| | | | 46,575,776 | | | | | | 31,099,891 | | |
|
Inventories
|
| | | | 1,296,577 | | | | | | 1,142,569 | | |
|
Prepayments, net
|
| | | | 10,274,207 | | | | | | 5,814,691 | | |
|
Deposits and other assets, net
|
| | | | 295,754 | | | | | | 120,485 | | |
|
Due from related parties
|
| | | | 2,862 | | | | | | 394,582 | | |
|
Total Current Assets
|
| | | | 61,415,375 | | | | | | 40,082,702 | | |
| NON-CURRENT ASSETS | | | | | | | | | | | | | |
|
Property and equipment, net
|
| | | | 7,141,064 | | | | | | 6,138,694 | | |
|
Intangible assets, net
|
| | | | 16,528 | | | | | | 25,479 | | |
|
Deferred tax assets
|
| | | | 714,461 | | | | | | 814,372 | | |
|
Right-of-use assets
|
| | | | 475,119 | | | | | | 861,331 | | |
|
Deferred offering costs
|
| | | | — | | | | | | 875,258 | | |
|
Goodwill
|
| | | | 57,772 | | | | | | 59,375 | | |
|
Prepayments – non current
|
| | | | 8,021,046 | | | | | | 7,698,728 | | |
|
Deposits and other assets – non current
|
| | | | 121,505 | | | | | | 152,450 | | |
|
Total Non-Current Assets
|
| | | | 16,547,495 | | | | | | 16,625,687 | | |
|
Total Assets
|
| | | $ | 77,962,870 | | | | | $ | 56,708,389 | | |
| CURRENT LIABILITIES | | | | | | | | | | | | | |
|
Short-term bank loans
|
| | | | 16,166,000 | | | | | | 8,166,400 | | |
|
Tax payables
|
| | | | 2,873,453 | | | | | | 770,953 | | |
|
Salaries and benefits payable
|
| | | | 797,912 | | | | | | 750,635 | | |
|
Contract liability
|
| | | | 792,102 | | | | | | 499,905 | | |
|
Short-term lease liabilities
|
| | | | 264,316 | | | | | | 503,891 | | |
|
Accounts payable
|
| | | | 1,252,667 | | | | | | 550,188 | | |
|
Amounts due to a related party
|
| | | | 3,703,700 | | | | | | 3,785,250 | | |
|
Accrued listing expenses payable
|
| | | | 5,341,848 | | | | | | 2,172,651 | | |
|
Accrued expenses and other payables
|
| | | | 2,518,175 | | | | | | 864,687 | | |
|
Deferred tax liabilities
|
| | | | 45,238 | | | | | | 93,389 | | |
|
Long-term loan – current portion
|
| | | | 867,772 | | | | | | 817,485 | | |
|
Total Current Liabilities
|
| | | | 34,623,183 | | | | | | 18,975,434 | | |
| NON-CURRENT LIABILITIES | | | | | | | | | | | | | |
|
Long-term lease liabilities
|
| | | | 136,683 | | | | | | 412,121 | | |
|
Long-term loan – non current
|
| | | | 3,442,526 | | | | | | 1,613,579 | | |
|
Total Non-Current Liabilities
|
| | | | 3,579,209 | | | | | | 2,025,700 | | |
|
Total Liabilities
|
| | | $ | 38,202,392 | | | | | $ | 21,001,134 | | |
| Commitments and Contingencies (Note 20) | | | | | | | | | | | | | |
| Equity | | | | | | | | | | | | | |
|
Preferred shares, $0.0001 par value; 5,000,000 shares authorized; 290,000 shares issued and outstanding
as of December 31, 2024; none authorized, issued and outstanding as of December 31,2023 |
| | | | 29 | | | | | | — | | |
|
Ordinary shares, $0.0001 par value; 500,000,000 shares authorized; 35,728,625 and 35,728,625 shares issued,25,555,096 and 25,555,096 shares outstanding as of December 31, 2024 and 2023, respectively*
|
| | | | 2,556 | | | | | | 2,556 | | |
|
Additional paid-in capital*
|
| | | | 11,441,712 | | | | | | 18,850,677 | | |
|
Statutory reserve
|
| | | | 4,591,151 | | | | | | 4,508,366 | | |
|
Retained earnings
|
| | | | 26,764,751 | | | | | | 14,394,167 | | |
|
Accumulated other comprehensive loss
|
| | | | (3,141,061) | | | | | | (2,005,122) | | |
|
Total Baird Medical Investment Holdings Limited’s Shareholders’ Equity
|
| | | | 39,659,138 | | | | | | 35,750,644 | | |
|
Non-controlling interests
|
| | | | 101,340 | | | | | | (43,389) | | |
|
Total Liabilities and Equity
|
| | | $ | 77,962,870 | | | | | $ | 56,708,389 | | |
(All amounts in U.S. dollars, except for share and per share data, or otherwise noted)
| | | |
For the years ended December 31,
|
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Revenues
|
| | | $ | 37,037,108 | | | | | $ | 31,457,908 | | | | | $ | 35,091,174 | | |
|
Cost of revenues
|
| | | | (4,383,363) | | | | | | (4,227,409) | | | | | | (7,054,323) | | |
|
Gross profit
|
| | | | 32,653,745 | | | | | | 27,230,499 | | | | | | 28,036,851 | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | |
|
Selling and marketing expenses
|
| | | | (4,061,116) | | | | | | (2,547,000) | | | | | | (3,585,138) | | |
|
General and administrative expenses
|
| | | | (7,103,226) | | | | | | (8,546,880) | | | | | | (6,960,604) | | |
|
Research and development expenses
|
| | | | (6,174,365) | | | | | | (4,274,894) | | | | | | (3,859,392) | | |
|
Total operating expenses
|
| | | | (17,338,707) | | | | | | (15,368,774) | | | | | | (14,405,134) | | |
|
Income from operations
|
| | | | 15,315,038 | | | | | | 11,861,725 | | | | | | 13,631,717 | | |
|
Interest expense
|
| | | | (576,752) | | | | | | (285,833) | | | | | | (299,269) | | |
|
Interest income
|
| | | | 393 | | | | | | 1,562 | | | | | | 8,553 | | |
|
Subsidy income
|
| | | | 266 | | | | | | 791,959 | | | | | | 1,375,447 | | |
|
Other expenses, net
|
| | | | (651,657) | | | | | | (10,211) | | | | | | (194,580) | | |
|
Income before income tax
|
| | | | 14,087,288 | | | | | | 12,359,202 | | | | | | 14,521,868 | | |
|
Income tax provision
|
| | | | (1,489,190) | | | | | | (1,701,019) | | | | | | (1,746,897) | | |
|
Net income
|
| | | | 12,598,098 | | | | | | 10,658,183 | | | | | | 12,774,971 | | |
|
Less: Net income attributable to non-controlling interests
|
| | | | (144,729) | | | | | | (112,205) | | | | | | (206,221) | | |
|
Net income attributable to Baird Medical Investment Holdings
Limited’s shareholders |
| | | | 12,453,369 | | | | | | 10,545,978 | | | | | | 12,568,750 | | |
| Other comprehensive loss | | | | | | | | | | | | | | | | | | | |
|
Foreign currency translation adjustment
|
| | | | (1,135,939) | | | | | | (728,688) | | | | | | (1,506,905) | | |
|
Total comprehensive income
|
| | | | 11,462,159 | | | | | | 9,929,495 | | | | | | 11,268,066 | | |
|
Non-controlling interests
|
| | | | (144,729) | | | | | | (112,205) | | | | | | (206,221) | | |
|
Comprehensive income attributable to Baird Medical Investment Holdings Limited’s shareholders
|
| | | $ | 11,317,430 | | | | | $ | 9,817,290 | | | | | $ | 11,061,845 | | |
|
Net income per share, basic*
|
| | | $ | 0.49 | | | | | $ | 0.41 | | | | | $ | 0.49 | | |
|
Net income per share, diluted*
|
| | | $ | 0.49 | | | | | $ | 0.41 | | | | | $ | 0.49 | | |
|
Weighted average number of shares-basic*
|
| | | | 25,555,096 | | | | | | 25,555,096 | | | | | | 25,555,096 | | |
|
Weighted average number of shares-diluted*
|
| | | | 25,627,992 | | | | | | 25,555,096 | | | | | | 25,555,096 | | |
(In U.S. dollars, except for share and per share data, or otherwise noted)
| | | |
Ordinary shares*
|
| |
Preferred shares
|
| |
Additional
paid-in capital* |
| |
Statutory
reserve |
| |
Retained
earnings / (accumulated deficit) |
| |
Accumulated
other comprehensive (loss)/gain |
| |
Total
shareholder’s equity |
| |
Non-
controlling interests |
| |
Total
equity |
| |||||||||||||||||||||||||||||||||||||||
| | | |
Shares
|
| |
Amounts
|
| |
Shares
|
| |
Amounts
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Balance at January 1, 2022
|
| | | | 25,555,096 | | | | | | 2,556 | | | | | | — | | | | | | — | | | | | | 18,847,327 | | | | | | 3,020,971 | | | | | | (7,233,166) | | | | | | 230,471 | | | | | | 14,868,159 | | | | | | (358,465) | | | | | | 14,509,694 | | |
|
Issuance of common stocks
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Net income
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 12,568,750 | | | | | | — | | | | | | 12,568,750 | | | | | | 206,221 | | | | | | 12,774,971 | | |
|
Appropriation of statutory reserve
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,374,348 | | | | | | (1,374,348) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Foreign currency translation adjustments
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,506,905) | | | | | | (1,506,905) | | | | | | — | | | | | | (1,506,905) | | |
|
Repurchase of non-controlling interests
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 3,350 | | | | | | — | | | | | | — | | | | | | — | | | | | | 3,350 | | | | | | (3,350) | | | | | | — | | |
|
Balance at December 31, 2022
|
| | | | 25,555,096 | | | | | | 2,556 | | | | | | — | | | | | | — | | | | | | 18,850,677 | | | | | | 4,395,319 | | | | | | 3,961,236 | | | | | | (1,276,434) | | | | | | 25,933,354 | | | | | | (155,594) | | | | | | 25,777,760 | | |
|
Net income for the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 10,545,978 | | | | | | — | | | | | | 10,545,978 | | | | | | 112,205 | | | | | | 10,658,183 | | |
|
Appropriation of statutory reserve
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 113,047 | | | | | | (113,047) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Foreign currency translation adjustments
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (728,688) | | | | | | (728,688) | | | | | | — | | | | | | (728,688) | | |
|
Balance at December 31, 2023
|
| | | | 25,555,096 | | | | | | 2,556 | | | | | | — | | | | | | — | | | | | | 18,850,677 | | | | | | 4,508,366 | | | | | | 14,394,167 | | | | | | (2,005,122) | | | | | | 35,750,644 | | | | | | (43,389) | | | | | | 35,707,255 | | |
|
Net income for the year
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 12,453,369 | | | | | | — | | | | | | 12,453,369 | | | | | | 144,729 | | | | | | 12,598,098 | | |
|
PIPE financing
|
| | | | — | | | | | | — | | | | | | 290,000 | | | | | | 29 | | | | | | 2,899,971 | | | | | | — | | | | | | — | | | | | | — | | | | | | 2,900,000 | | | | | | — | | | | | | 2,900,000 | | |
|
Capitalization of PIPE financing
costs |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (2,900,000) | | | | | | — | | | | | | — | | | | | | — | | | | | | (2,900,000) | | | | | | — | | | | | | (2,900,000) | | |
|
Reverse Recapitalization transaction
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (7,408,936) | | | | | | — | | | | | | — | | | | | | — | | | | | | (7,408,936) | | | | | | — | | | | | | (7,408,936) | | |
|
Appropriation of statutory reserve
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 82,785 | | | | | | (82,785) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Foreign currency translation adjustment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,135,939) | | | | | | (1,135,939) | | | | | | — | | | | | | (1,135,939) | | |
|
Balance at December 31, 2024
|
| | | | 25,555,096 | | | | | | 2,556 | | | | | | 290,000 | | | | | | 29 | | | | | | 11,441,712 | | | | | | 4,591,151 | | | | | | 26,764,751 | | | | | | (3,141,061) | | | | | | 39,659,138 | | | | | | 101,340 | | | | | | 39,760,478 | | |
| | | |
For the years ended December 31,
|
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | | | | | | | | | | | | | | | | | | | |
|
Net income
|
| | | $ | 12,598,098 | | | | | $ | 10,658,183 | | | | | $ | 12,774,971 | | |
|
Adjustments to reconcile net income to net cash (used in)/provided by operating activities:
|
| | | | | | | | | | | | | | | | | | |
|
Depreciation and amortization
|
| | | | 1,139,131 | | | | | | 1,014,387 | | | | | | 916,115 | | |
|
Deferred tax expense (benefit)
|
| | | | 32,774 | | | | | | (541,987) | | | | | | (143,317) | | |
|
Allowance for credit losses
|
| | | | 2,345,747 | | | | | | 2,221,430 | | | | | | 438,997 | | |
|
Recovery of allowance for expected credit losses
|
| | | | (1,099,404) | | | | | | — | | | | | | — | | |
|
Prepaid and other current assets provision
|
| | | | — | | | | | | 117,679 | | | | | | — | | |
|
Loss from disposal of property and equipment
|
| | | | — | | | | | | — | | | | | | (5,421) | | |
|
Amortization of right-of-use assets
|
| | | | 368,264 | | | | | | 366,427 | | | | | | 553,916 | | |
|
Changes in assets and liabilities:
|
| | | | | | | | | | | | | | | | | | |
|
Accounts receivable
|
| | | | (17,799,751) | | | | | | (9,674,507) | | | | | | (14,839,326) | | |
|
Inventories
|
| | | | (187,543) | | | | | | 113,661 | | | | | | 1,568,326 | | |
|
Prepayments
|
| | | | (4,683,841) | | | | | | (5,292,606) | | | | | | (3,566,229) | | |
|
Deposits and other assets
|
| | | | (153,904) | | | | | | (149,773) | | | | | | 115,053 | | |
|
Right-of-use assets
|
| | | | — | | | | | | (9,102) | | | | | | (881,431) | | |
|
Accounts payable
|
| | | | 727,800 | | | | | | 341,525 | | | | | | (100,934) | | |
|
Contract liabilities
|
| | | | 310,151 | | | | | | (173,101) | | | | | | 45,449 | | |
|
Lease liabilities
|
| | | | (497,449) | | | | | | (253,605) | | | | | | 389,481 | | |
|
Accrued expenses and other payables
|
| | | | (1,567,492) | | | | | | 1,213,891 | | | | | | 1,343,230 | | |
|
Taxes payable
|
| | | | 2,154,304 | | | | | | (972,466) | | | | | | 1,139,858 | | |
|
Income tax receivables
|
| | | | — | | | | | | — | | | | | | 737,230 | | |
|
Net cash (used in) /provided by operating activities
|
| | | | (6,313,115) | | | | | | (1,019,964) | | | | | | 485,968 | | |
| CASH FLOWS FROM INVESTING ACTIVITIES: | | | | | | | | | | | | | | | | | | | |
|
Purchase of property and equipment
|
| | | | (2,853,678) | | | | | | (2,638,488) | | | | | | (5,909,308) | | |
|
Purchase of intangible assets
|
| | | | — | | | | | | — | | | | | | (44,821) | | |
|
Proceeds from disposal of equipment
|
| | | | — | | | | | | — | | | | | | 32,665 | | |
|
Net cash used in investing activities
|
| | | | (2,853,678) | | | | | | (2,638,488) | | | | | | (5,921,464) | | |
| CASH FLOWS FROM FINANCING ACTIVITIES: | | | | | | | | | | | | | | | | | | | |
|
Proceeds from short-term bank loans
|
| | | | 19,323,780 | | | | | | 9,601,600 | | | | | | 9,065,240 | | |
|
Repayments of short-term bank loans
|
| | | | (10,983,780) | | | | | | (7,483,600) | | | | | | (4,606,925) | | |
|
Proceeds from long-term loan
|
| | | | 2,780,000 | | | | | | 2,548,794 | | | | | | — | | |
|
Payment of long-term loan
|
| | | | (806,764) | | | | | | (194,041) | | | | | | — | | |
|
Proceeds from PIPE investment
|
| | | | 2,900,000 | | | | | | — | | | | | | — | | |
|
Due from related parties
|
| | | | — | | | | | | 48,120 | | | | | | 301,454 | | |
|
Due to a related party
|
| | | | 407,545 | | | | | | (182,010) | | | | | | (347,851) | | |
|
Payment of listing cost
|
| | | | (2,900,000) | | | | | | (877,745) | | | | | | — | | |
|
Net cash provided by financing activities
|
| | | | 10,720,781 | | | | | | 3,461,118 | | | | | | 4,411,918 | | |
|
Effect of exchange rate changes
|
| | | | (94,273) | | | | | | (3,108) | | | | | | (297,647) | | |
|
Net change in cash
|
| | | | 1,459,715 | | | | | | (200,442) | | | | | | (1,321,225) | | |
|
Cash at beginning of year
|
| | | $ | 1,510,484 | | | | | $ | 1,710,926 | | | | | $ | 3,032,151 | | |
|
Cash at end of the year
|
| | | $ | 2,970,199 | | | | | $ | 1,510,484 | | | | | $ | 1,710,926 | | |
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | | | | | | | | | | | | | | | | | | | |
|
Cash paid for income taxes
|
| | | $ | 1,837,708 | | | | | $ | 2,644,786 | | | | | $ | 1,439,558 | | |
|
Cash paid for interest
|
| | | $ | 497,247 | | | | | $ | 261,323 | | | | | $ | 243,838 | | |
|
SUPPLEMENTAL DISCLOSURE OF NONCASH FLOW INFORMATION:
|
| | | | | | | | | | | | | | | | | | |
|
Right-of-use assets obtained in exchange for operating lease liabilities
|
| | | $ | — | | | | | $ | 19,701 | | | | | $ | 907,952 | | |
|
Name of Entity
|
| |
Date of
Incorporation/ Acquisition |
| |
Place of
Incorporation |
| |
Shareholders
|
| |
% of
Equity Ownership |
| |
Principal Activities
|
|
| Betters Medical NewCo, LLC (“NewCo”) | | |
June 17, 2024 / October 1,
2024 |
| |
Delaware (US)
|
| |
PubCo
|
| |
100%
|
| |
Holding
|
|
| ExcelFin Acquisition Corp. (“SPAC” or “ExcelFin”) | | |
March 15,
2021 / October 1, 2024 |
| |
Delaware (US)
|
| |
PubCo
|
| |
100%
|
| |
Holding
|
|
| Baird Medical LLC | | |
November 29,
2023 |
| |
Delaware (US)
|
| |
PubCo
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Tycoon Choice Global Limited (“Tycoon”) | | |
January 8,
2021 |
| |
BVI
|
| |
PubCo
|
| |
100%
|
| |
Holding
|
|
| Baide Medical Investment Company Limited (“Baide HK”) | | |
January 29,
2021 |
| |
Hong Kong
|
| |
Tycoon
|
| |
100%
|
| |
Holding
|
|
| Baide (Guangdong) Capital Management Company Limited (“Baide Capital”) | | |
March 3,
2021 |
| |
The PRC
|
| |
Baide HK
|
| |
100%
|
| |
Sales of MWA
medical devices and investment holding |
|
| Guangzhou Dedao Capital Management Company Limited (“Dedao”) | | |
March 4,
2021 |
| |
The PRC
|
| |
Baide Capital
|
| |
99%
|
| |
Holding
|
|
| Guangzhou Baihui Corporate Management Company Limited (“Baihui”) | | |
December 4,
2020 |
| |
The PRC
|
| |
Dedao
|
| |
99%
|
| |
Holding
|
|
| Guangzhou Zhengde Corporate Management Company Limited | | |
December 4,
2020 |
| |
The PRC
|
| |
Dedao
|
| |
99%
|
| |
Holding
|
|
| Guangzhou Yide Capital Management Company Limited | | |
December 10,
2020 |
| |
The PRC
|
| |
Dedao
|
| |
99%
|
| |
Holding
|
|
| Baide (Suzhou) Medical Company Limited (“Baide Suzhou”) | | |
June 5,
2012 |
| |
The PRC
|
| |
Zhengde Yide,
and Baihui |
| |
99%
|
| |
Research and
development, sales of MWA and other medical devices and investment holding |
|
| Henan Ruide Medical Instrument Company Limited | | |
July 6,
2018 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA and
other medical devices |
|
| Nanjing Changcheng Medical Equipment Company Limited (“Nanjing Changcheng”) | | |
January 28,
2016 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Research and
development, manufacture and sales of MWA and other medical devices |
|
| Guizhou Baiyuan Medical Company Limited | | |
September 21,
2017 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of other
medical devices |
|
|
Name of Entity
|
| |
Date of
Incorporation/ Acquisition |
| |
Place of
Incorporation |
| |
Shareholders
|
| |
% of
Equity Ownership |
| |
Principal Activities
|
|
| Guoke Baide (Guangdong) Medical Company Limited (“Guoke Baide”) | | |
July 5, 2019
|
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Hunan Baide Medical Technology Company Limited | | |
November 26,
2019 |
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Ruikede Biological Technology (Xiamen) Company Limited (“Ruikede Xiamen”) | | |
July 17, 2019
|
| |
The PRC
|
| |
Baide Suzhou
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Guangzhou Fangda Medical Technology Company Limited | | |
December 22,
2022 |
| |
The PRC
|
| |
Baide Capital
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Junde (Guangzhou) Medical Technology Company Limited | | |
November 14,
2022 |
| |
The PRC
|
| |
Guoke Baide
|
| |
99%
|
| |
Sales of MWA
medical devices |
|
| Shengde (Guangzhou) Medical Technology Company Limited | | |
November 29,
2022 |
| |
The PRC
|
| |
Baide Capital
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Suzhou Kangchuang Medical Company Limited | | |
December 6,
2022 |
| |
The PRC
|
| |
Baide Capital
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| Hainan Haike Baide Medical Company Limited | | |
July 4,2024
|
| |
The PRC
|
| |
Baide Suzhou
|
| |
100%
|
| |
Sales of MWA
medical devices |
|
| | | |
Useful life
|
|
| Machinery | | | 3 – 10 years | |
| Furniture, fixtures and equipment | | | 3 – 5 years | |
| Vehicles | | | 4 years | |
| Medical equipment | | | 6 – 10 years | |
| Leasehold improvement | | | Over the lease term or estimated useful lives of 5 years, whichever is shorter | |
| | | |
Useful life
|
|
| Patent | | | 6 years | |
| Software | | | 5 years | |
| | | |
Individual basis
|
| |
Aging group basis
|
| |
Total
|
| |||||||||
|
Trade accounts receivable
|
| | | $ | 1,991,596 | | | | | $ | 31,949,487 | | | | | $ | 33,941,083 | | |
|
Less: allowance for doubtful accounts
|
| | | | (1,991,596) | | | | | | (849,596) | | | | | | (2,841,192) | | |
|
Accounts receivable, net
|
| | | | — | | | | | $ | 31,099,891 | | | | | $ | 31,099,891 | | |
|
Allowance Ratio
|
| | | | 100% | | | | | | 2.7% | | | | | | 8.4% | | |
| | | |
Number of
shares |
| |||
|
Baird Medical Investment Holdings Limited’s ordinary shares outstanding at December 31, 2023
|
| | | | 29,411,765 | | |
|
Baird Medical Investment Holdings Limited’s ordinary shares outstanding prior to the Reverse Recapitalization
|
| | | | 29,411,765 | | |
|
Conversion of original Baird Medical Investment Holdings Limited Shareholders ordinary shares
|
| | | | 20,588,236 | | |
|
Conversion of SPAC Sponsor ordinary shares
|
| | | | 4,400,000 | | |
|
Conversion of Working capital loan ordinary shares
|
| | | | 278,406 | | |
|
Conversion of Public Shareholders ordinary shares
|
| | | | 288,454 | | |
|
Total number of ordinary shares as of closing of the Reverse Recapitalization
|
| | | | 25,555,096 | | |
|
Total number of Series A convertible preferred shares as of closing of PIPE transactions
|
| | | | 290,000 | | |
| | | |
For the year
ended December 31, 2024 |
| |||
|
Cash held by ExcelFin and cash related to ExcelFin trust account
|
| | | $ | 9,238,626 | | |
|
Less redemptions
|
| | | | (6,043,240) | | |
|
Cash related to trust account, net of redemptions
|
| | | | 3,195,386 | | |
|
Less cash paid associated with transaction costs allocated to Reverse Recapitalization
|
| | | | (3,116,936) | | |
|
Less cash paid on behalf of the Company for professional expenses
|
| | | | (78,450) | | |
|
Proceeds from PIPE financing – Grand Fortune Capital, LLC
|
| | | | 2,900,000 | | |
|
Less cash payment associated with transaction costs allocated to PIPE
|
| | | | (2,900,000) | | |
|
Net contributions from Reverse Recapitalization and PIPE financing
|
| | | $ | — | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Accounts receivable
|
| | | $ | 50,568,698 | | | | | $ | 33,941,083 | | |
|
Less: allowance for credit losses
|
| | | | (3,992,922) | | | | | | (2,841,192) | | |
|
Accounts receivable, net
|
| | | $ | 46,575,776 | | | | | $ | 31,099,891 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Balance at the beginning of the year
|
| | | $ | (2,841,192) | | | | | $ | (644,669) | | | | | $ | (234,190) | | |
|
Additions charged to allowance for expected credit losses
|
| | | | (2,345,747) | | | | | | (2,221,430) | | | | | | (438,997) | | |
|
Recovery of allowance for expected credit losses
|
| | | | 1,099,404 | | | | | | — | | | | | | — | | |
|
Foreign currency translation adjustments
|
| | | | 94,613 | | | | | | 24,907 | | | | | | 28,518 | | |
|
Balance at the end of the year
|
| | | $ | (3,992,922) | | | | | $ | (2,841,192) | | | | | $ | (644,669) | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Not Overdue
|
| | | $ | 13,225,014 | | | | | $ | 9,941,205 | | |
|
Within 90 days
|
| | | | 9,983,041 | | | | | | 10,373,938 | | |
|
Between 3 and 6 months
|
| | | | 7,247,650 | | | | | | 6,188,966 | | |
|
Between 6 months and a year
|
| | | | 11,801,484 | | | | | | 5,982,205 | | |
|
Over a year
|
| | | | 8,311,509 | | | | | | 1,454,769 | | |
| | | | | $ | 50,568,698 | | | | | $ | 33,941,083 | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Finished goods
|
| | | $ | 717,312 | | | | | $ | 312,871 | | |
|
Raw materials
|
| | | | 348,910 | | | | | | 516,346 | | |
|
Work in progress
|
| | | | 230,355 | | | | | | 313,352 | | |
|
Inventories
|
| | | $ | 1,296,577 | | | | | $ | 1,142,569 | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Prepayment for R&D
|
| | | $ | 13,296,763 | | | | | $ | 7,649,949 | | |
|
Prepayment for purchase of property and equipment
|
| | | | 1,378,198 | | | | | | 2,528,912 | | |
|
Prepayment for purchase of materials and others
|
| | | | 3,305,963 | | | | | | 2,726,440 | | |
|
Prepaid expense for others
|
| | | | 319,196 | | | | | | 613,120 | | |
|
Subtotal
|
| | | | 18,300,120 | | | | | | 13,518,421 | | |
|
Less: impairment loss
|
| | | | (4,867) | | | | | | (5,002) | | |
|
Subtotal, net
|
| | | | 18,295,253 | | | | | | 13,513,419 | | |
|
Less: Long term portion
|
| | | | (8,021,046) | | | | | | (7,698,728) | | |
|
Prepayments, net – current portion
|
| | | $ | 10,274,207 | | | | | $ | 5,814,691 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Balance at the beginning of the year
|
| | | $ | (5,002) | | | | | $ | — | | | | | $ | — | | |
|
Additions charged to the impairment loss
|
| | | | — | | | | | | (5,016) | | | | | | — | | |
|
Foreign currency translation adjustments
|
| | | | 135 | | | | | | 14 | | | | | | — | | |
|
Balance at the end of the year
|
| | | $ | (4,867) | | | | | $ | (5,002) | | | | | $ | — | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Deposits
|
| | | $ | 185,282 | | | | | $ | 217,658 | | |
|
Other receivables
|
| | | | 341,288 | | | | | | 167,620 | | |
|
Subtotal
|
| | | $ | 526,570 | | | | | $ | 385,278 | | |
|
Less: allowance of credit loss
|
| | | | (109,311) | | | | | | (112,343) | | |
|
Subtotal, net
|
| | | $ | 417,259 | | | | | $ | 272,935 | | |
|
Less: Long term portion
|
| | | | (121,505) | | | | | | (152,450) | | |
|
Deposits and other assets- current portion
|
| | | $ | 295,754 | | | | | $ | 120,485 | | |
| | | |
For the years ended December 31,
|
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Balance at the beginning
|
| | | $ | (112,343) | | | | | $ | — | | | | | $ | — | | |
|
Additions charged to allowance for expected credit losses
|
| | | | — | | | | | | (112,663) | | | | | | — | | |
|
Foreign currency translation adjustments
|
| | | | 3,032 | | | | | | 320 | | | | | | — | | |
|
Balance at the end
|
| | | $ | (109,311) | | | | | $ | (112,343) | | | | | $ | — | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Leasehold improvement
|
| | | $ | 4,327,441 | | | | | $ | 4,656,762 | | |
|
Machinery
|
| | | | 6,600,001 | | | | | | 4,227,161 | | |
|
Furniture, fixtures and equipment
|
| | | | 435,052 | | | | | | 447,902 | | |
|
Motor vehicles
|
| | | | 41,184 | | | | | | 42,326 | | |
|
Medical equipment
|
| | | | 331,960 | | | | | | 341,168 | | |
|
Total
|
| | | | 11,735,638 | | | | | | 9,715,319 | | |
|
Less: Accumulated depreciation
|
| | | | (4,594,574) | | | | | | (3,576,625) | | |
|
Property and equipment, net
|
| | | $ | 7,141,064 | | | | | $ | 6,138,694 | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Patent
|
| | | $ | 246,600 | | | | | $ | 253,440 | | |
|
Software
|
| | | | 41,319 | | | | | | 42,465 | | |
|
Less: accumulated amortization
|
| | | | (271,392) | | | | | | (270,426) | | |
|
Intangible assets, net
|
| | | $ | 16,528 | | | | | $ | 25,479 | | |
|
Years ending December 31,
|
| |
Amortization
expense |
| |||
|
2025
|
| | | | 8,264 | | |
|
2026
|
| | | | 8,264 | | |
|
Total
|
| | | $ | 16,528 | | |
|
Lender
|
| |
Company
|
| |
Guarantors/
Collateral |
| |
Effective
Interest Rate |
| |
Issuance
Date |
| |
Expiration
Date |
| |
Amount-
RMB |
| |
Amount-
US$ |
|
| Industrial and Commercial Bank of China | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.00%
|
| | January 12,2024 | | | January 11,2025 | | |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | | Baihui | | |
2.55%
|
| |
September 13, 2024
|
| | March 13,2025 | | |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.00%
|
| | November 11,2024 | | | March 26,2025 | | |
10,000,000
|
| |
1,370,000
|
|
| China Merchants Bank | | | Baide Suzhou | | | Baihui | | |
2.55%
|
| | October 31, 2024 | | |
October 28, 2025
|
| |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
2.55%
|
| | November 6,2024 | | | November 5,2025 | | |
5,000,000
|
| |
685,000
|
|
| China Merchants Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
2.55%
|
| | November 7,2024 | | | May 5,2025 | | |
5,000,000
|
| |
685,000
|
|
| Jiangsu Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.30%
|
| | December 4,2024 | | | December 3,2025 | | |
5,000,000
|
| |
685,000
|
|
| Bank of China | | | Baide Suzhou | | |
Nanjing Changcheng/ Baide capital |
| |
3.10%
|
| | December 6,2024 | | | December 5,2025 | | |
10,000,000
|
| |
1,370,000
|
|
| China CITIC Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.00%
|
| | December 25,2024 | | | December 25,2025 | | |
10,000,000
|
| |
1,370,000
|
|
| China CITIC Bank | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.00%
|
| | December 26,2024 | | | June 26,2025 | | |
10,000,000
|
| |
1,370,000
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
3.95%
|
| | May 14, 2024 | | | May 14, 2025 | | |
4,000,000
|
| |
548,000
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
|
| |
4.15%
|
| | March 27, 2024 | | | March 27, 2025 | | |
6,000,000
|
| |
822,000
|
|
| Bank of Communications Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.40%
|
| | May 6, 2024 | | | May 6, 2025 | | |
5,000,000
|
| |
685,000
|
|
| Bank of Communications Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng
|
| |
3.40%
|
| | May 11, 2024 | | | May 11, 2025 | | |
5,000,000
|
| |
685,000
|
|
| China Minsheng Bank | | | Baide Suzhou | | | N/A | | |
4.10%
|
| | April 26, 2024 | | | April 25, 2025 | | |
3,000,000
|
| |
411,000
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
4.05%
|
| | August 26,2024 | | | August 19,2025 | | |
2,000,000
|
| |
274,000
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.85%
|
| | November 21,2024 | | | November 19,2025 | | |
3,000,000
|
| |
411,000
|
|
| Bank of China | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.36%
|
| |
September 26, 2024
|
| | June 20,2025 | | |
3,000,000
|
| |
411,000
|
|
| Hangzhou Bank | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.90%
|
| | January 30, 2024 | | | January 29, 2025 | | |
10,000,000
|
| |
1,370,000
|
|
| Bank of China Nanjing Hexi Branch | | |
Nanjing Changcheng
|
| | Baide Suzhou | | |
3.36%
|
| | June 26, 2024 | | | June 20, 2025 | | |
7,000,000
|
| |
959,000
|
|
| Total | | | | | | | | | | | | | | | | | |
118,000,000
|
| |
16,166,000
|
|
|
Lender
|
| |
Company
|
| |
Guarantors/
Collateral |
| |
Effective
Interest Rate |
| |
Issuance
Date |
| |
Expiration
Date |
| |
Amount-
RMB |
| |
Amount-US$
|
|
| Taicang Sub-branch, Suzhou Branch,China Merchants Bank | | | Baide Suzhou | | | Guangzhou Baihui | | |
3.90%
|
| | August 8, 2023 | | | August 8, 2024 | | |
5,000,000
|
| |
704,000
|
|
| Taicang Sub-branch, Suzhou Branch,China Merchants Bank | | | Baide Suzhou | | | Guangzhou Baihui | | |
2.50%
|
| | August 9, 2023 | | | August 7, 2024 | | |
5,000,000
|
| |
704,000
|
|
| Taicang Sub-branch, Suzhou Branch,China Merchants Bank | | | Baide Suzhou | | | Nanjing Changcheng | | |
2.50%
|
| | August 25, 2023 | | | August 23, 2024 | | |
10,000,000
|
| |
1,408,000
|
|
| China Merchants Bank Guangzhou Guanggang New City Sub-branch | | | Baide Suzhou | | | Nanjing Changcheng | | |
2.50%
|
| | July 21, 2023 | | | July 19, 2024 | | |
10,000,000
|
| |
1,408,000
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
AR from Baide Suzhou |
| |
3.95%
|
| | May 15, 2023 | | | May 15, 2024 | | |
4,000,000
|
| |
563,200
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
AR from Baide Suzhou |
| |
3.95%
|
| |
September 21, 2023
|
| | March 27, 2024 | | |
6,000,000
|
| |
844,800
|
|
| China CITIC Bank Suzhou Branch | | | Baide Suzhou | | |
Nanjing Changcheng,
AR from Baide Suzhou |
| |
4.15%
|
| |
December 29, 2023
|
| | June 29, 2024 | | |
10,000,000
|
| |
1,408,000
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | / | | |
4.05%
|
| |
November 27, 2023
|
| |
November 19, 2024
|
| |
3,000,000
|
| |
422,400
|
|
| Bank of Nanjing | | |
Nanjing Changcheng
|
| | / | | |
3.95%
|
| | March 16, 2023 | | | March 15, 2024 | | |
5,000,000
|
| |
704,000
|
|
| Total | | | | | | | | | | | | | | | | | |
58,000,000
|
| |
$8,166,400
|
|
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Financial liabilities
|
| | | $ | 1,570,298 | | | | | $ | 2,431,064 | | |
|
Less: current portion
|
| | | | (867,772) | | | | | | (817,485) | | |
|
Long-term Financial liabilities
|
| | | | 702,526 | | | | | | 1,613,579 | | |
|
Long-term Bank borrowings
|
| | | | 2,740,000 | | | | | | — | | |
|
Total long-term loan
|
| | | $ | 3,442,526 | | | | | $ | 1,613,579 | | |
|
Lender
|
| |
Company
|
| |
Guarantors/
Collateral |
| |
Effective
Interest Rate |
| |
Issuance
Date |
| |
Expiration
Date |
| |
Amount-
RMB |
| |
Amount-US$
|
|
| Bank of China | | |
Baide Suzhou
|
| |
Nanjing Changcheng/
Baide capital |
| |
3.10%
|
| |
December 18, 2024
|
| |
December 17, 2027
|
| |
20,000,000
|
| |
2,740,000
|
|
| | Years ending December 31, | | | | | | | |
| |
2025 Financial liabilities payment
|
| | | $ | 977,829 | | |
| |
2026 Financial liabilities payment
|
| | | | 733,386 | | |
| |
Total Financial liabilities payments
|
| | | $ | 1,711,215 | | |
| |
Less: Financial liabilities imputed interest
|
| | | | (140,917) | | |
| |
Total Financial liabilities payment
|
| | | $ | 1,570,298 | | |
| |
Less: Financial liabilities – long term portions
|
| | | | (702,526) | | |
| |
Financial liabilities payment – current portions
|
| | | $ | 867,772 | | |
| |
2027 Long-term Bank borrowings repayment
|
| | | $ | 2,740,000 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Cash payments for operating leases
|
| | | $ | 533,803 | | | | | $ | 326,125 | | | | | $ | 515,147 | | |
|
Right-of-use assets obtained in exchange for operating lease liabilities
|
| | | | — | | | | | | 19,701 | | | | | | 907,952 | | |
| | | |
Operating
leases |
| |||
|
2025
|
| | | $ | 263,577 | | |
|
2026
|
| | | | 114,856 | | |
|
2027
|
| | | | 29,440 | | |
|
Total future lease payments
|
| | | $ | 407,873 | | |
|
Less: imputed interest
|
| | | | (6,874) | | |
|
Total lease liabilities
|
| | | $ | 400,999 | | |
|
Less: Long term portions
|
| | | | (136,683) | | |
|
Lease liabilities – current portions
|
| | | $ | 264,316 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Current tax expense
|
| | | $ | 1,456,416 | | | | | $ | 2,243,006 | | | | | $ | 1,890,214 | | |
|
Deferred tax benefit
|
| | | | 32,774 | | | | | | (541,987) | | | | | | (143,317) | | |
|
Income tax provision
|
| | | $ | 1,489,190 | | | | | $ | 1,701,019 | | | | | $ | 1,746,897 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Cayman Islands
|
| | | $ | — | | | | | $ | (15,080) | | | | | $ | — | | |
|
United States
|
| | | | (1,908,434) | | | | | | — | | | | | | — | | |
|
Hong Kong
|
| | | | 12,719 | | | | | | (733,151) | | | | | | (2,731,396) | | |
|
PRC
|
| | | | 15,983,003 | | | | | | 13,107,433 | | | | | | 17,253,264 | | |
| | | | | $ | 14,087,287 | | | | | $ | 12,359,202 | | | | | $ | 14,521,868 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
PRC statutory income tax rate
|
| | | | 25.0% | | | | | | 25.0% | | | | | | 25.0% | | |
|
Effect of different tax rates in non-PRC (foreign) jurisdiction
|
| | | | 0.5% | | | | | | 1.0% | | | | | | 3.2% | | |
|
Effect of PRC preferential tax rate and tax holidays
|
| | | | (11.5)% | | | | | | (10.8)% | | | | | | (14.2)% | | |
|
R&D credits
|
| | | | (6.6)% | | | | | | (4.2)% | | | | | | (4.1)% | | |
|
Deferred offering cost
|
| | | | — | | | | | | (0.9)% | | | | | | — | | |
|
Non-deductible expenses*
|
| | | | 0.1% | | | | | | 3.2% | | | | | | 1.4% | | |
|
Tax effect on deferred tax allowance
|
| | | | 2.9% | | | | | | 0.5% | | | | | | 0.7% | | |
|
Effective tax rate
|
| | | | 10.6% | | | | | | 13.8% | | | | | | 12.0% | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
| Deferred tax assets: | | | | | | | | | | | | | |
|
Allowance for expected credit losses
|
| | | $ | 552,486 | | | | | $ | 420,988 | | |
|
Net operating loss carryforward
|
| | | | 901,272 | | | | | | 732,294 | | |
|
Lease liabilities
|
| | | | 36,118 | | | | | | 102,639 | | |
|
Total deferred tax assets
|
| | | $ | 1,489,876 | | | | | $ | 1,255,921 | | |
|
Less: Valuation allowance
|
| | | | (775,415) | | | | | | (441,549) | | |
|
Deferred tax assets, net
|
| | | $ | 714,461 | | | | | $ | 814,372 | | |
| Deferred tax liabilities: | | | | | | | | | | | | | |
|
Right-of-use assets
|
| | | | 45,238 | | | | | | 93,389 | | |
|
Total deferred tax liabilities
|
| | | $ | 45,238 | | | | | $ | 93,389 | | |
| | | |
As of December 31,
|
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Beginning balance
|
| | | $ | (441,549) | | | | | $ | (405,796) | | | | | $ | (329,139) | | |
|
Increase in valuation allowance
|
| | | | (345,783) | | | | | | (47,604) | | | | | | (101,691) | | |
|
Foreign exchange
|
| | | | 11,916 | | | | | | 11,851 | | | | | | 25,034 | | |
|
Ending balance
|
| | | $ | (775,415) | | | | | $ | (441,549) | | | | | $ | (405,796) | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
VAT tax payable
|
| | | $ | 358,792 | | | | | $ | 281,363 | | |
|
Income tax payable
|
| | | | 79,167 | | | | | | 448,230 | | |
|
Other tax payables****
|
| | | | 2,435,494 | | | | | | 41,360 | | |
|
Total tax payables
|
| | | $ | 2,873,453 | | | | | $ | 770,953 | | |
|
Net Operating Loss Carry Forward:
|
| |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
| Location | | | | | | | | | | | | | |
|
PRC*
|
| | | $ | 2,591,421 | | | | | $ | 3,785,480 | | |
|
Hong Kong**
|
| | | | 1,022,574 | | | | | | 1,051,678 | | |
|
United States***
|
| | | | 1,888,111 | | | | | | — | | |
|
Total
|
| | | $ | 5,502,106 | | | | | $ | 4,837,158 | | |
| | | |
For the Year Ended December 31,
|
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
| Numerator: | | | | | | | | | | | | | | | | | | | |
|
Net income attributable to the Company’s ordinary shareholders – basic
|
| | | $ | 12,453,369 | | | | | $ | 10,545,978 | | | | | $ | 12,568,750 | | |
|
Dilution impact of the convertible preferred shares
|
| | | | 50,750 | | | | | | — | | | | | | — | | |
|
Net income attributable to the Company’s ordinary shareholders – diluted
|
| | | | 12,504,119 | | | | | | 10,545,978 | | | | | | 12,568,750 | | |
| Denominator: | | | | | | | | | | | | | | | | | | | |
|
Weighted average number of shares – basic
|
| | | | 25,555,096 | | | | | | 25,555,096 | | | | | | 25,555,096 | | |
|
Effects of dilutive securities: convertible preferred shares
|
| | | | 72,896 | | | | | | — | | | | | | — | | |
|
Weighted average number of shares – diluted
|
| | | | 25,627,992 | | | | | | 25,555,096 | | | | | | 25,555,096 | | |
|
Net income per share, basic
|
| | | $ | 0.49 | | | | | $ | 0.41 | | | | | $ | 0.49 | | |
|
Net income per share, diluted
|
| | | $ | 0.49 | | | | | $ | 0.41 | | | | | $ | 0.49 | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
| Due from related parties: | | | | | | | | | | | | | |
|
Haimei Wu(1)
|
| | | $ | — | | | | | $ | 391,641 | | |
|
Betters Medical Investment Holdings Limited
|
| | | | 2,862 | | | | | | 2,941 | | |
|
Total
|
| | | $ | 2,862 | | | | | $ | 394,582 | | |
| Due to related parties: | | | | | | | | | | | | | |
|
Betters Medical Investment Holdings Limited(2)
|
| | | $ | 3,703,700 | | | | | $ | 3,785,250 | | |
|
Total
|
| | | $ | 3,703,700 | | | | | $ | 3,785,250 | | |
| | | |
Payment Due by Period
|
| |||||||||||||||
| | | |
Total
|
| |
Less than 1
Year |
| |
1-3 Years
|
| |||||||||
|
Short-term bank loans
|
| | | $ | 16,166,000 | | | | | $ | 16,166,000 | | | | | $ | — | | |
|
Lease payment
|
| | | | 407,873 | | | | | | 263,577 | | | | | | 144,296 | | |
|
Long term loan
|
| | | | 4,451,215 | | | | | | 977,829 | | | | | | 3,473,386 | | |
|
Total
|
| | | $ | 21,025,088 | | | | | $ | 17,407,406 | | | | | $ | 3,617,682 | | |
| | | |
Year Ended December 31,
|
| |||||||||||||||
| | | |
2022
|
| |
2023
|
| |
2024
|
| |||||||||
| | | |
US$
|
| |
US$
|
| |
US$
|
| |||||||||
|
Revenues
|
| | | $ | 35,091,174 | | | | | $ | 31,457,908 | | | | | $ | 37,037,108 | | |
|
Cost of revenues
|
| | | | (7,054,323) | | | | | | (4,227,409) | | | | | | (4,383,363) | | |
|
Gross profit
|
| | | | 28,036,851 | | | | | | 27,230,499 | | | | | | 32,653,745 | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | |
|
Selling and marketing expenses
|
| | | | (3,585,138) | | | | | | (2,547,000) | | | | | | (4,061,116) | | |
|
General and administrative expenses
|
| | | | (6,960,604) | | | | | | (8,546,880) | | | | | | (7,103,226) | | |
|
Research and development expenses
|
| | | | (3,859,392) | | | | | | (4,274,894) | | | | | | (6,174,365) | | |
|
Total operating expenses
|
| | | | (14,405,134) | | | | | | (15,368,774) | | | | | | (17,338,707) | | |
|
Income from operations
|
| | | | 13,631,717 | | | | | | 11,861,725 | | | | | | 15,315,038 | | |
|
Interest expense
|
| | | | (299,269) | | | | | | (285,833) | | | | | | (576,752) | | |
|
Interest income
|
| | | | 8,553 | | | | | | 1,562 | | | | | | 393 | | |
|
Subsidy income
|
| | | | 1,375,447 | | | | | | 791,959 | | | | | | 266 | | |
|
Other expenses, net
|
| | | | (194,580) | | | | | | (10,211) | | | | | | (651,657) | | |
|
Income before income tax
|
| | | | 14,521,868 | | | | | | 12,359,202 | | | | | | 14,087,288 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Distributors
|
| | | $ | 17,220,009 | | | | | $ | 14,995,701 | | | | | $ | 13,499,170 | | |
|
Direct customers(1)
|
| | | | 19,817,099 | | | | | | 16,462,207 | | | | | | 21,592,004 | | |
|
Total
|
| | | $ | 37,037,108 | | | | | $ | 31,457,908 | | | | | $ | 35,091,174 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
At a point of time
|
| | | $ | 37,037,108 | | | | | $ | 31,457,908 | | | | | $ | 35,091,174 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
MWA devices
|
| | | $ | 37,027,277 | | | | | $ | 30,940,383 | | | | | $ | 31,283,234 | | |
|
– MWA needles
|
| | | | 33,826,455 | | | | | | 26,278,169 | | | | | | 30,551,145 | | |
|
– MWA therapeutic apparatus
|
| | | | 3,200,822 | | | | | | 4,662,214 | | | | | | 732,089 | | |
|
Other medical devices
|
| | | | 9,831 | | | | | | 517,525 | | | | | | 3,807,940 | | |
|
Total
|
| | | $ | 37,037,108 | | | | | $ | 31,457,908 | | | | | $ | 35,091,174 | | |
| | | |
As of December 31,
|
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
| ASSETS | | | | | | | | | | | | | |
|
Amounts due from related parties
|
| | | | 2,941 | | | | | | 2,941 | | |
|
Investments in subsidiaries
|
| | | $ | 39,656,197 | | | | | $ | 35,747,703 | | |
|
Total Assets
|
| | | $ | 39,659,138 | | | | | $ | 35,750,644 | | |
| Shareholders’ Equity | | | | | | | | | | | | | |
|
Preferred shares, $0.0001 par value; 5,000,000 shares authorized; 290,000 shares issued and outstanding as of December 31, 2024; none authorized, issued and outstanding as of December 31, 2023
|
| | | | 29 | | | | | | — | | |
|
Ordinary shares, $0.0001 par value; 500,000,000 shares and 500,000,000 shares authorized; 35,728,625 shares issued and 35,728,625 shares issued, 25,555,096 shares outstanding and 25,555,096 shares outstanding as of December 31, 2024 and December 31, 2023, respectively*
|
| | | $ | 2,556 | | | | | | 2,556 | | |
|
Additional paid-in capital*
|
| | | | 11,441,712 | | | | | | 18,850,677 | | |
|
Retained earnings
|
| | | | 31,355,902 | | | | | | 18,902,533 | | |
|
Accumulated other comprehensive loss
|
| | | | (3,141,061) | | | | | | (2,005,122) | | |
|
Total Shareholders’ Equity
|
| | | | 39,659,138 | | | | | | 35,750,644 | | |
|
Total Liabilities and Shareholders’ Equity
|
| | | $ | 39,659,138 | | | | | $ | 35,750,644 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
|
Share of profit in subsidiaries, net (Note a)
|
| | | $ | 12,453,369 | | | | | $ | 10,545,978 | | | | | $ | 12,568,750 | | |
|
Income before income tax
|
| | | | 12,453,369 | | | | | | 10,545,978 | | | | | | 12,568,750 | | |
|
Income tax provision
|
| | | | — | | | | | | — | | | | | | — | | |
|
Net income
|
| | | | 12,453,369 | | | | | | 10,545,978 | | | | | | 12,568,750 | | |
|
Other comprehensive (loss) income
|
| | | | | | | | | | | | | | | | | | |
|
Foreign currency translation loss
|
| | | $ | (1,135,939) | | | | | $ | (728,688) | | | | | $ | (1,506,905) | | |
|
Comprehensive income
|
| | | $ | 11,317,430 | | | | | $ | 9,817,290 | | | | | $ | 11,061,845 | | |
| | | |
For the years ended
December 31, |
| |||||||||||||||
| | | |
2024
|
| |
2023
|
| |
2022
|
| |||||||||
| Cash flows from operating activities | | | | | | | | | | | | | | | | | | | |
|
Net income
|
| | | $ | 12,453,369 | | | | | $ | 10,545,978 | | | | | $ | 12,568,750 | | |
|
Adjustments to reconcile net income to net cash provided by
operating activities: |
| | | | | | | | | | | | | | | | | | |
|
Equity income in subsidiaries
|
| | | | (12,453,369) | | | | | | (10,545,978) | | | | | | (12,568,750) | | |
|
Net cash provided by operating activities
|
| | | | — | | | | | | — | | | | | | — | | |
|
Cash at beginning of year
|
| | | $ | — | | | | | $ | — | | | | | | — | | |
|
Cash at the end of the year
|
| | | $ | — | | | | | $ | — | | | | | $ | — | | |
FAQ
What securities is Baird Medical (BDMD) registering in this prospectus?
Baird Medical is registering up to 11,500,000 ordinary shares issuable upon exercise of public warrants at US$11.50 per share, plus up to 34,415,562 ordinary shares for potential resale by existing selling securityholders.
Will Baird Medical (BDMD) receive any cash from this registered resale?
No. Baird Medical will not receive proceeds from sales of the 34,415,562 registered resale shares. It would only receive cash if holders exercise the 11,500,000 warrants for cash, which the company considers unlikely at a share price of US$1.63 versus an US$11.50 exercise price.
How large is the potential resale overhang relative to Baird Medical’s outstanding shares?
The company states that, assuming all warrants are exercised and GFC preferred shares convert, the 34,415,562 resale shares would equal approximately 70.9% of issued and outstanding ordinary shares as of December 4, 2025.
Who are the main selling securityholders in the Baird Medical (BDMD) filing?
Key selling securityholders include 16 shareholders of Betters Medical holding 27,463,627 ordinary shares, the SPAC sponsor with 6,028,406 Sponsor Shares, J.V.B. Financial Group, LLC with 50,000 shares, Grand Fortune Capital, LLC with up to 290,000 shares upon preferred conversion, and Grand Fortune Capital (H.K.) Company Limited with 583,529 shares.
What are the main China-related risks highlighted by Baird Medical (BDMD)?
The company operates through PRC subsidiaries and cites risks from complex and evolving PRC regulations, restrictions on cash transfers and dividends, potential new CSRC filing requirements for future overseas offerings, cybersecurity and data rules, and broader government intervention that could adversely affect operations and the value of the ordinary shares.
How does the HFCAA affect Baird Medical (BDMD) and its Nasdaq listing?
The company explains that under the Holding Foreign Companies Accountable Act, if the PCAOB is unable to completely inspect auditors in China and the company uses such an auditor for two consecutive years without replacement, its ordinary shares could be prohibited from trading on U.S. exchanges and over-the-counter markets, which could cause the share value to significantly decline.
What business does Baird Medical (BDMD) operate and where are its operations based?
Baird Medical is a Cayman Islands holding company whose operations are conducted through wholly owned PRC subsidiaries. It focuses on microwave ablation medical devices for thyroid and liver applications, with Class II and Class III medical device registrations in China and a growing hospital customer base.