CapsoVision (NASDAQ: CV) posts flat Q1 2026 sales and raises $14M
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
CapsoVision, Inc. reported first quarter 2026 revenue of $2.8 million, essentially unchanged from the prior year period, as a small decline in capsule volume was offset by a slightly higher average selling price. Gross margin fell to 48% from 54%, reflecting the impact of changes in U.S. trade policies and tariffs.
Operating expenses increased to $8.4 million, mainly from development work under a Canon Inc. agreement and clinical trials for the second-generation CapsoCam Colon, leading to a wider net loss of $7.0 million. Cash and cash equivalents rose to $17.9 million as of March 31, 2026, helped by completion of a $14 million private placement of equity on March 16, 2026. The company highlighted progress toward anticipated FDA clearance of its AI-assisted reading feature for CapsoCam Plus and ongoing pipeline programs in colon and pancreatic cancer diagnostics.
Positive
- None.
Negative
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Insights
Flat revenue but higher spend widens losses, offset by fresh cash.
CapsoVision delivered Q1 2026 revenue of $2.8M, essentially flat year over year, showing a stable base of capsule endoscopy usage. However, gross margin compressed to 48% from 54% due to U.S. trade and tariff impacts, reducing profitability on each procedure.
Operating expenses rose to $8.4M, up from $6.9M, driven by R&D for new CMOS image sensors with Canon and clinical trials for second-generation CapsoCam Colon. This pushed net loss to $7.0M from $5.4M, as the company invests heavily in its pipeline.
On the balance sheet, cash increased to $17.9M after a $14M private placement, providing additional runway to pursue AI-assisted reading for CapsoCam Plus, a planned 510(k) submission for second-generation CapsoCam Colon in Q3 2026, and a new pancreatic cancer study with first patient enrolled in May 2026. Subsequent filings may detail how quickly these programs translate into revenue growth or margin recovery.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Q1 2026 revenue: $2,792,000
Q1 2025 revenue: $2,783,000
Q1 2026 gross margin: 48%
+5 more
8 metrics
Q1 2026 revenue
$2,792,000
Net revenue for three months ended March 31, 2026
Q1 2025 revenue
$2,783,000
Net revenue for three months ended March 31, 2025
Q1 2026 gross margin
48%
Gross profit $1.329M on revenue $2.792M
Q1 2026 operating expenses
$8,422,000
Selling and marketing, R&D, G&A combined
Q1 2026 net loss
$7,033,000
Net loss and comprehensive loss for three months ended March 31, 2026
Cash and equivalents
$17,933,000
Balance as of March 31, 2026
Private placement proceeds
$14,000,000
Proceeds from private placement in public equity on March 16, 2026
Shares outstanding
49,838,867 shares
Common stock issued and outstanding as of March 31, 2026
Key Terms
capsule endoscopy, AI-assisted reading feature, private placement of public equity financing, 510(k) submission, +2 more
6 terms
capsule endoscopy medical
"a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions"
A capsule endoscopy is a diagnostic procedure in which a person swallows a pill-sized device that contains a tiny camera, light and transmitter; it wirelessly records images as it travels through the digestive tract. Investors care because the technology can replace or complement traditional, more invasive tests — affecting demand, device sales, recurring consumable revenue, regulatory approval paths and insurance coverage, all of which influence a medical company’s growth and profitability.
AI-assisted reading feature technical
"CapsoVision’s AI-assisted reading feature for CapsoCam Plus, on track for anticipated FDA clearance mid-year"
private placement of public equity financing financial
"Completed a $14 million private placement of public equity financing on March 16, 2026"
510(k) submission regulatory
"second-generation of CapsoCam Colon with 510(k) submission expected in the third quarter of 2026"
A 510(k) submission is a regulatory packet sent to the U.S. Food and Drug Administration showing a medical device is substantially similar to an already-allowed device so it can be marketed without a full, new safety review. For investors, clearance via 510(k) cuts time and cost to bring a device to market and reduces regulatory risk—think of it as proving a new model is close enough to a trusted one to sell it more quickly.
forward-looking statements regulatory
"This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
operating loss financial
"Operating loss | (7,093) | | | (5,382)"
Operating loss occurs when a company’s regular business activities—sales of goods or services—bring in less money than it costs to run the business, like a shop whose daily sales don’t cover rent and wages. For investors, it signals that the core business isn’t currently profitable, which can increase cash burn, affect future dividends or financing needs, and change how the company’s value and risk are judged.
Earnings Snapshot
Revenue: $2,792,000
Q1 2026
Revenue
$2,792,000
stable vs. $2,783,000 Q1 2025
Gross margin
48%
down from 54% Q1 2025
Operating expenses
$8,422,000
up from $6,876,000 Q1 2025
Net loss
$7,033,000
wider than $5,375,000 Q1 2025
Cash and equivalents
$17,933,000
up from $10,112,000 December 31, 2025
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________
FORM 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2026
_________________________
(Exact name of registrant as specified in its charter)
_________________________
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification Number) | ||||||||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (408) -624-1488
n/a
(Former Name or Former Address, if Changed Since Last Report)
_________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 14, 2026, the Company issued a press release announcing its financial results for the fiscal quarter ended March 31, 2026. A copy of the press release, dated May 14, 2026, is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing information in this Item 2.02 (including the exhibit hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
The following exhibits are being filed herewith:
| Exhibit No. | Description | |||||||
| 99.1 | Press Release of CapsoVision, Inc, dated May 14, 2026. | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CAPSOVISION, INC. | ||||||||
| Date: May 14, 2026 | By: | /s/ Kang-Huai (Johnny) Wang | ||||||
| Name: | Kang-Huai (Johnny) Wang | |||||||
| Title | Director, President and Chief Executive Officer | |||||||
Exhibit 99.1
CapsoVision Reports First Quarter 2026 Financial Results
SARATOGA, Calif., May 14, 2026 - CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today reported financial results for its first quarter ended March 31, 2026.
Recent Highlights
•Delivered first quarter revenue of $2.8 million, stable compared to the first quarter of 2025.
•Existing customers continued to expand clinical use of CapsoCam Plus® for small bowel disease detection, while procedure volume demonstrated growing adoption and end-user consumption.
•Secured key customer renewals with large GI networks, including Indiana University Health Systems, Providence Health Systems, and Gastro Health, reinforcing platform value and long-term relationships.
•CapsoCam Plus® used by over 167,000 patients as of March 31, 2026.
•CapsoVision’s AI-assisted reading feature for CapsoCam Plus, on track for anticipated FDA clearance mid-year, with commercial launch expected shortly thereafter, subject to FDA review timelines.
•Pipeline programs progressing as planned, including our second-generation of CapsoCam Colon with 510(k) submission expected in the third quarter of 2026, and initiation of a clinical study for CapsoCam UGI in pancreatic cancer detection with the first patient enrolled in May 2026.
•Completed a $14 million private placement of public equity financing on March 16, 2026.
Management Commentary
“We saw continued strength in underlying utilization during the first quarter, reflecting deeper engagement across our installed base and the increasing role CapsoCam Plus® is playing in clinical practice,” said Johnny Wang, President and Chief Executive Officer of CapsoVision. “Importantly, we also secured key renewals with large GI networks, reinforcing the durability of our customer relationships and the value of our platform.
"At the same time, we are approaching an important inflection point with the anticipated FDA clearance of our AI-assisted reading feature for CapsoCam Plus®, which we believe will further enhance workflow efficiency for physicians and we received positive feedback at recent industry meetings. Across the pipeline, we remain on track, including progress on the second-generation of our CapsoCam Colon capsule and the recent initiation of our pancreatic cancer study with initial patient enrollment. Taken together, we believe we are well positioned to continue advancing our platform and executing on our long-term strategy.”
First Quarter 2026 Financial Results
Total revenue was $2.8 million, stable compared to $2.8 million in the first quarter of 2025, due to a 3% decrease in capsule volume, offset by a slight increase in average selling price.
Gross profit was $1.3 million, a decrease of $0.2 million, or 11%, compared to $1.5 million in the first quarter of 2025. Gross margin was 48%, compared to 54% in the first quarter of 2025. The decrease was due to the impact of changes in U.S. trade policies and tariffs.
Operating expenses were $8.4 million, a $1.5 million increase from the first quarter of 2025, driven primarily by the development of the new CMOS image sensors under the development agreement with Canon Inc., as well as clinical trial activities supporting the second-generation of CapsoCam Colon.
Cash and cash equivalents totaled $17.9 million as of March 31, 2026.
On March 16, 2026, the Company closed a $14 million private placement in public equity financing.
Conference Call and Webcast
CapsoVision will host a conference call today, May 14, 2026, at 4:30 p.m. ET to discuss its first quarter financial results. Individuals interested in listening to the conference call may do so by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers and referencing conference ID 5439091, or from the webcast link on the Events page in the investor relations section of the company's website at www.capsovision.com.
To access the replay, please register via the webcast link on the Events page. The webcast will be available for one year following the completion of the call.
About CapsoVision
CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and screening of gastrointestinal diseases. Its flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video retrieval. The Company’s next pipeline product, CapsoCam Colon™ with enhanced AI, is designed to enable non-invasive colon imaging and polyp detection. With a proprietary platform targeted to expand across multiple GI indications, including esophageal and pancreatic disorders, CapsoVision is advancing a new era in capsule-based diagnostics. For more information on CapsoVision, please visit www.capsovision.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as “expected”, “positioned”, “on track”, “anticipate(s)”, “intend(s)”, “plan(s)”, “believe(s)”, “potential”, “will”, “should”, “could”, “would”, “may”, “continue”, “remain”, “advancing”, “approach(ing)”, or “target(ed)” and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, statements concerning possible or assumed future results of operations and financial position, including the Company’s expectations regarding the Company’s product and clinical development efforts, the timing and receipt of regulatory submissions and approvals (including anticipated FDA clearance of our AI-assisted reading feature for CapsoCam Plus® and commercial launch expected shortly thereafter), the Company’s plans, strategies and timing for its pipeline development (including the study for second-generation of CapsoCam Colon and related 510(k) submission, and the clinical study for CapsoCam UGI in pancreatic cancer detection) and the success of the Company’s plans and strategies. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties, including those beyond the Company’s control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions, the Company’s financial condition and the availability of cash and financing, the success of the Company’s product and clinical development efforts, the failure to receive regulatory clearance and the failure to adapt the Company’s products for new indications. These and other risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s most recent Form 10-K and Form 10-Q. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as required by law.
Investor Relations Contact
Leigh Salvo
New Street Investor Relations
Investors@CapsoVision.com
Media Contact
Leslie Strickler and Paul Spicer
Être Communications
leslies@etrecommunications.com | (804) 240-0807
pauls@etrecommunications.com | (804) 503-9231
CAPSOVISION, INC.
CONDENSED BALANCE SHEETS (UNAUDITED)
(in thousands, except par value and share amounts)
| March 31, 2026 | December 31, 2025 | ||||||||||
| ASSETS | |||||||||||
| Current Assets | |||||||||||
| Cash and cash equivalents | $ | 17,933 | $ | 10,112 | |||||||
| Accounts receivable, net | 1,925 | 2,498 | |||||||||
| Inventory | 3,491 | 2,987 | |||||||||
| Prepaid expenses and other current assets | 1,151 | 1,072 | |||||||||
| Total current assets | 24,500 | 16,669 | |||||||||
| Property and equipment, net | 620 | 611 | |||||||||
| Operating lease right-of-use assets | 749 | 843 | |||||||||
| Other long-term assets | 76 | 41 | |||||||||
| TOTAL ASSETS | $ | 25,945 | $ | 18,164 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current Liabilities | |||||||||||
| Accounts payable | $ | 1,359 | $ | 1,143 | |||||||
| Accrued expenses and other current liabilities | 3,494 | 2,697 | |||||||||
| Deferred revenue | 84 | 177 | |||||||||
| Operating lease liabilities – current | 426 | 410 | |||||||||
| Total current liabilities | 5,363 | 4,427 | |||||||||
| Operating lease liabilities – long-term | 362 | 477 | |||||||||
| Total liabilities | 5,725 | 4,904 | |||||||||
| Commitments and contingencies - Note 8 | |||||||||||
| Stockholders’ Equity | |||||||||||
Common stock, $0.001 par value: 300,000,000 and 300,000,000 shares authorized; 49,838,867 and 46,865,051 issued and outstanding as of March 31, 2026 and December 31, 2025, respectively | 50 | 47 | |||||||||
| Additional paid-in capital | 182,868 | 168,878 | |||||||||
| Accumulated deficit | (162,698) | (155,665) | |||||||||
| Total stockholders’ equity | 20,220 | 13,260 | |||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 25,945 | $ | 18,164 | |||||||
CAPSOVISION, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per-share amounts)
| Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Net revenue | $ | 2,792 | $ | 2,783 | |||||||
| Costs of revenue | 1,463 | $ | 1,289 | ||||||||
| Gross profit | 1,329 | 1,494 | |||||||||
| OPERATING EXPENSES | |||||||||||
| Selling and marketing | 2,091 | 1,961 | |||||||||
| Research and development | 4,435 | 3,107 | |||||||||
| General and administrative | 1,896 | 1,808 | |||||||||
| Total operating expenses | 8,422 | 6,876 | |||||||||
| Operating loss | (7,093) | (5,382) | |||||||||
| NON-OPERATING INCOME | |||||||||||
| Interest income, net | 59 | 6 | |||||||||
| Other non-operating income, net | 1 | 1 | |||||||||
| Total non-operating income, net | 60 | 7 | |||||||||
| Loss before income taxes | (7,033) | (5,375) | |||||||||
| Provision for income taxes | — | — | |||||||||
| Net loss and comprehensive loss | $ | (7,033) | $ | (5,375) | |||||||
| Net loss per share – basic and diluted | $ | (0.15) | $ | (2.49) | |||||||
| Weighted average common shares outstanding – basic and diluted | 47,456,908 | 2,157,627 | |||||||||
CAPSOVISION, INC.
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)
Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||
| Net loss | $ | (7,033) | $ | (5,375) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation and amortization | 56 | 52 | |||||||||
| Loss on disposal of property and equipment | 1 | — | |||||||||
| Amortization of operating lease right-of-use assets | 94 | 85 | |||||||||
| Unrealized foreign exchange gains | (4) | (12) | |||||||||
| Stock-based compensation | 334 | 152 | |||||||||
| Bad debt expense | — | 11 | |||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts receivable | 594 | 296 | |||||||||
| Inventory | (504) | (408) | |||||||||
| Prepaid expenses and other current assets | 8 | (621) | |||||||||
| Other long-term assets | (35) | — | |||||||||
| Accounts payable | 198 | 134 | |||||||||
| Accrued expenses and other current liabilities | 417 | 833 | |||||||||
| Deferred revenue | (93) | (48) | |||||||||
| Operating lease liabilities | (99) | (85) | |||||||||
| Net cash used in operating activities | $ | (6,066) | $ | (4,986) | |||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||
| Purchases of property and equipment | (48) | (40) | |||||||||
| Net cash used in investing activities | $ | (48) | $ | (40) | |||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||
| Proceeds from Private Placement | 14,000 | — | |||||||||
| Payment of Private Placement issuance costs | (87) | — | |||||||||
| Proceeds from exercises of options on common stock and warrants | 39 | 34 | |||||||||
| Net cash provided by financing activities | $ | 13,952 | $ | 34 | |||||||
| Net increase (decrease) in cash and cash equivalents | 7,838 | (4,992) | |||||||||
| Effect of exchange rate changes on cash and cash equivalents | (17) | 71 | |||||||||
| Cash and cash equivalents at beginning of period | 10,112 | 9,319 | |||||||||
| Cash and cash equivalents at end of period | $ | 17,933 | $ | 4,398 | |||||||
| NON-CASH FINANCING AND INVESTING ACTIVITIES | |||||||||||
| Private Placement issuance costs in accounts payable and accruals | $ | 380 | — | ||||||||
FAQ
How did CapsoVision (CV) perform financially in Q1 2026?
CapsoVision reported Q1 2026 revenue of $2.8 million, essentially flat versus $2.8 million a year earlier. Net loss widened to $7.0 million from $5.4 million as operating expenses increased, mainly from product development and clinical trial activities.
What happened to CapsoVision’s margins in the first quarter of 2026?
CapsoVision’s gross margin declined to 48% in Q1 2026 from 54% a year earlier. Management attributed the lower margin primarily to the impact of changes in U.S. trade policies and tariffs on the company’s costs of revenue.
How much cash does CapsoVision (CV) have after the Q1 2026 private placement?
CapsoVision ended March 31, 2026 with $17.9 million in cash and cash equivalents. This reflects a $14 million private placement of equity completed on March 16, 2026, partially offset by operating and investing cash outflows during the quarter.
What are CapsoVision’s key pipeline and regulatory milestones as of Q1 2026?
CapsoVision is pursuing FDA clearance of its AI-assisted reading feature for CapsoCam Plus, anticipated mid-year. It also plans a 510(k) submission for its second-generation CapsoCam Colon in Q3 2026 and has initiated a CapsoCam UGI study in pancreatic cancer.
How is CapsoVision (CV) investing in growth and R&D in early 2026?
Operating expenses were $8.4 million in Q1 2026, up from $6.9 million a year earlier. The increase was driven mainly by development of new CMOS image sensors under a Canon agreement and clinical trial activities for second-generation CapsoCam Colon.
What did CapsoVision’s 8-K filed on May 14, 2026 disclose?
The 8-K disclosed first quarter 2026 financial results and furnished the related press release as an exhibit. It highlighted flat revenue at $2.8 million, a wider net loss, increased R&D spending, and completion of a $14 million private placement of equity.