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Picard Medical (NYSE American: PMI) posts 85% revenue jump and details Emperor total artificial heart roadmap

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Rhea-AI Filing Summary

Picard Medical, Inc. filed an amended report to replace a prior press release with a corrected version describing its 2026 annual stockholder presentation ahead of the virtual Annual Meeting on July 17, 2026. The presentation reviews recent business performance, product development, manufacturing initiatives, and proposals to be considered by stockholders.

For the first three months of 2026, the company reports an 85% year-over-year increase in revenue, driven by a 116% increase in U.S. revenue. Gross margin was 24% for this period, compared with -4% in 2025. Management highlights ongoing manufacturing optimization efforts to strengthen quality control, improve supply chain resilience, and reduce production costs.

The company also outlines progress on its next-generation Emperor platform, an electromechanical drive system intended to replace the current external pneumatic driver and ultimately support a fully implantable total artificial heart using wireless power transfer and internal control. Planned milestones include pursuit of FDA Breakthrough Device designation, continued preclinical studies, an Investigational Device Exemption submission in 2028, and the start of clinical studies in 2029, subject to discussions with the FDA.

Positive

  • Strong early-2026 growth and margin turnaround: revenue for the first three months of 2026 rose 85% year over year, U.S. revenue increased 116%, and gross margin improved to 24% from -4% in 2025.

Negative

  • None.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Revenue growth 85% year-over-year increase Revenue for the first three months of 2026 compared with the prior year period
U.S. revenue growth 116% increase U.S. revenue for the first three months of 2026 year over year
Gross margin 2026 24% Gross margin for the first three months of 2026
Gross margin 2025 -4% Gross margin in 2025 cited for comparison
Total artificial heart implants More than 2,100 implants SynCardia Total Artificial Heart implants performed at hospitals across 27 countries
Countries with implants 27 countries Geographic reach of SynCardia Total Artificial Heart implants
Planned IDE submission 2028 Target year for Investigational Device Exemption submission for the Emperor platform
Planned clinical studies start 2029 Intended start of clinical study activities for the Emperor platform, in consultation with FDA
Investigational Device Exemption regulatory
"a planned Investigational Device Exemption submission in 2028"
An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.
Breakthrough Device designation regulatory
"include pursuit of FDA Breakthrough Device designation"
A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.
total artificial heart medical
"maker of the world's first total artificial heart approved by both"
A total artificial heart is a surgically implanted mechanical device that replaces the heart’s two main pumping chambers and takes over circulation, acting like a continuous pump that keeps blood moving through the body. Investors care because it is a high-cost, high-stakes medical product whose commercial success depends on clinical trial results, regulatory approvals, hospital adoption, reimbursement rules and long-term patient outcomes — factors that drive revenue potential and risk.
preclinical studies medical
"continued preclinical studies, a planned Investigational Device Exemption submission"
Preclinical studies are initial research tests conducted in laboratories and on animals to evaluate the safety, effectiveness, and potential risks of a new medical treatment or drug before it is tested in humans. For investors, these studies are an important early step that can indicate whether a product has the potential to advance toward approval and commercial use, influencing the future prospects and valuation of related companies.
electromechanical actuation platform technical
"a new electromechanical actuation platform designed to eliminate"
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FAQ

What is the main purpose of Picard Medical (PMI)'s amended 8-K filing?
The amended report replaces the prior Exhibit 99.1 with a corrected press release describing Picard Medical’s annual stockholder presentation, without changing any other items from the original July 2, 2026 report.

How did Picard Medical (PMI) perform financially in early 2026?
For the first three months of 2026, Picard Medical reports an 85% year-over-year revenue increase, driven by a 116% increase in U.S. revenue, and a gross margin of 24% versus -4% in 2025.

When is Picard Medical (PMI)'s 2026 Annual Meeting of Stockholders?
The 2026 Annual Meeting of Stockholders is scheduled to be held virtually on Friday, July 17, 2026, at 6:00 p.m. Eastern Time for stockholders of record as of the applicable record date.

What is Picard Medical (PMI)'s Emperor platform and why is it important?
The Emperor platform is a next-generation electromechanical actuation system intended to replace the external pneumatic driver and ultimately support a fully implantable total artificial heart with wireless power transfer and internal control.

What regulatory milestones does Picard Medical (PMI) plan for the Emperor platform?
Planned milestones include pursuit of FDA Breakthrough Device designation, continued preclinical studies, an Investigational Device Exemption submission in 2028, and the intent to begin clinical study activities in 2029.

What proposals will Picard Medical (PMI) stockholders consider at the 2026 Annual Meeting?
The presentation outlines proposals including election of directors, amendments to the company’s capital structure, ratification of the independent auditor, and advisory votes on executive compensation.

What business does Picard Medical (PMI) and SynCardia focus on?
Picard Medical is the parent of SynCardia, which develops and commercializes the SynCardia Total Artificial Heart, the only commercially available artificial heart in the United States and Canada, with over 2,100 implants across 27 countries.
Press Release, dated July 2, 2026_Amended true 0002030617 0002030617 2026-07-02 2026-07-02
 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K/A
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 
Date of Report (Date of earliest event reported): July 10, 2026 (July 2, 2026)
 
Picard Medical, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
  
001-42801
  
86-3212894
(State or other jurisdiction
of incorporation)
  
(Commission
File Number)
  
(IRS Employer
Identification No.)
 
1992 E Silverlake
Tucson AZ, 85713
(Address of principal executive offices, including zip code)
 
Registrant’s telephone number, including area code: (520) 545-1234
 
Not Applicable
(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(s)
  
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
  
PMI
  
The NYSE American, LLC
 
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. ☐
 
 
 
 
 
 
 
EXPLANATORY NOTE
 
This amendment to Current Report on Form 8-K/A (the “Amended Form 8-K”) is being filed by Picard Medical, Inc. (the "Company") solely to amend Item 9.01 of the Form 8-K filed on July 2, 2026 (“the Original Form 8-K”), in order to replace the press release that was furnished as Exhibit 99.1 to the Original Form 8-K (the “Original Press Release”) with a corrected press release. Such corrected press release is furnished as Exhibit 99.1 to this Amended Form 8-K, which replaces the Exhibit 99.1 filed with the Original Form 8-K in its entirety. No other changes were made to the Original Form 8-K other than to replace Exhibit 99.1. All other Items of the Original Form 8-K are unaffected by this Amended Form 8-K and such Items have not been included herein.
 
Item 8.01. Other Events.
 
On July 2, 2026, the Company filed the Original Form 8-K to announce the availability of a pre-recorded presentation in advance of the Company's 2026 Annual Meeting of Stockholders, scheduled for July 17, 2026. In connection with that event, the Company furnished a press release as Exhibit 99.1. The Company is furnishing herewith a corrected version of the press release as Exhibit 99.1 to this Amendment. 
 
Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit Number
Exhibit Description
99.1
 Press Release, dated July 2, 2026, as corrected.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
 
 
 
1
 
 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
  Picard Medical Inc.
   
   
     
  By:
/s/ Georgina Smith
  Name:
Georgina Smith
  Title: Chief Accounting Officer
 
Dated: July 10, 2026
 
 
2

Exhibit 99.1

 

Picard Medical / SynCardia Releases Annual Stockholder Presentation Ahead of 2026 Annual Meeting

 

- Presentation Highlights Business Progress, Product Development Milestones, and Matters for Stockholder Consideration-

 

 

TUCSON, Ariz., July 10, 2026 — Picard Medical, Inc. (NYSE American: PMI) ("Picard Medical" or the "Company"), parent company of SynCardia Systems, LLC ("SynCardia"), maker of the world's first total artificial heart approved by both the U.S. Food and Drug Administration and Health Canada, today announced the availability of its pre-recorded presentation in advance of the Company's 2026 Annual Meeting of Stockholders, scheduled for July 17, 2026. The presentation provides stockholders with an overview of the Company's recent business performance, product development progress, manufacturing initiatives, and the proposals to be considered at the Annual Meeting.

 

"Despite recent leadership changes, our mission remains unchanged," said Richard Fang, Ph.D., Interim Chief Executive Officer and Chairman of the Board. "We remain committed to advancing the development of a fully implantable total artificial heart while continuing to support physicians and patients with our current technologies. Our presentation highlights the meaningful progress we have made across our business, from strong first-quarter financial performance to continued innovation in our next-generation Emperor platform, and provides stockholders with important information regarding the proposals to be voted on at the Annual Meeting."

 

Among the business updates highlighted in the presentation were financial milestones including an 85% year-over-year increase in revenue for the first three months of 2026, driven by a 116% increase of U.S. revenue. Gross margin was 24% for the same period. Gross margin was -4% in 2025. Picard Medical also discussed ongoing manufacturing optimization initiatives designed to strengthen quality control, improve supply chain resilience, and reduce production costs.

 

The presentation also provides an update on the Company's next-generation Emperor platform, which builds on the clinically proven SynCardia Total Artificial Heart architecture through the Emperor Drive System, a new electromechanical actuation platform designed to eliminate the external pneumatic driver used with the Company's current products. The Company's initial Emperor configuration retains an external controller and battery, with a longer-term roadmap toward a fully implantable system utilizing wireless power transfer and internal control. Development milestones for this initial configuration include pursuit of FDA Breakthrough Device designation, continued preclinical studies, a planned Investigational Device Exemption submission in 2028, and an intent to begin clinical study activities in 2029, the scope and design of which will be determined in consultation with FDA.

 

The presentation concludes with an overview of the proposals to be considered by stockholders at the 2026 Annual Meeting, including the election of directors, proposed amendments to the Company's capital structure, ratification of its independent registered public accounting firm, and advisory votes regarding executive compensation. Stockholders are encouraged to review the Company's proxy materials and submit their votes prior to the meeting.

 

The Company's 2026 Annual Meeting of Stockholders will be held virtually on Friday, July 17, 2026, at 6:00 p.m. Eastern Time. Stockholders of record as of the applicable record date are eligible to vote by internet, telephone, or during the virtual meeting.

 

About Picard Medical and SynCardia

 

Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the STAH is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov.

 

Forward-looking Statements

 

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on management’s current expectations, assumptions, and beliefs and involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Forward-looking statements can often be identified by words such as “anticipate,” “believe,” “continue,” “expect,” “goal,” “intend,” “may,” “plan,” “remain,” “target,” “will,” “advance,” “expand,” and similar expressions, and variations or negatives of these words.

 

These statements include, but are not limited to, statements regarding the Company’s financial condition, future operating results, commercialization activities, expectations for growth, expanding utilization of the SynCardia Total Artificial Heart, expanding patient access at transplant centers, supporting clinical partners, advancing development of the Emperor Total Artificial Heart and other next-generation technologies, regulatory submissions and approvals, manufacturing and supply chain initiatives, capital raising activities, strengthening the Company’s commercial and financial position, strategic initiatives, leadership transitions, and other statements that are not historical facts.

 

Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Factors that may cause such differences include, but are not limited to, risks relating to the Company’s ability to obtain additional financing, maintain compliance with applicable stock exchange listing requirements, achieve commercial adoption of its products, obtain regulatory approvals, execute manufacturing and supply chain initiatives, successfully develop next-generation technologies, manage market conditions, and other risks described in the Company’s filings with the U.S. Securities and Exchange Commission (”SEC”).

 

 
 

 

The Company expressly disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances, or otherwise, except as required by law.

 

Additional information about the Company, including risk factors that may affect the Company’s business, financial condition, and results of operations, is contained in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available free of charge at www.sec.gov and on the Company’s investor relations website at www.picardmedical.com.

 

Contact:

 

Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
eric@lifesciadvisors.com

 

Picard Medical, Inc./SynCardia Systems, LLC
IR@picardmedical.com

 

General/Media
Brittany Lanza
blanza@syncardia.com

 

 

 

Source: View Original Filing on SEC EDGAR

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