Picard Medical touts 85% revenue growth, TAH roadmap

Picard Medical, Inc. filed a current report describing a pre-recorded presentation released ahead of its 2026 virtual Annual Meeting on July 17, 2026.

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Picard Medical, Inc. filed a current report describing a pre-recorded presentation released ahead of its 2026 virtual Annual Meeting on July 17, 2026. The presentation highlights recent business performance, including an 85% year-over-year increase in revenue and an improved gross margin of 28% from year-end 2025, driven by a 116% increase in U.S. revenue.

The company outlines manufacturing optimization initiatives and progress on its next-generation Emperor total artificial heart platform, which replaces the external pneumatic driver with an electromechanical system and has a roadmap toward a fully implantable device. Development plans include pursuit of FDA Breakthrough Device designation, an Investigational Device Exemption submission in 2028, and planned clinical study activities in 2029. The presentation also reviews proposals for director elections, capital structure changes, auditor ratification, and advisory votes on executive compensation to be considered at the Annual Meeting.

Positive

Strong reported growth metrics: The presentation cites an 85% year-over-year increase in revenue, a gross margin of 28% from year-end 2025, and a 116% increase in U.S. revenue, indicating significant recent operating momentum.
Clear long-term product roadmap: Detailed development plans for the Emperor total artificial heart platform, including targeted IDE submission in 2028 and clinical study activities in 2029, provide visibility into the company’s next-generation technology strategy.

Negative

None.

Insights

Picard Medical reports strong growth and details an ambitious artificial-heart roadmap.

Picard Medical highlights an 85% year-over-year revenue increase, a gross margin of 28% from year-end 2025, and a 116% increase in U.S. revenue. For an early-stage medical device platform, this combination of growth and margin improvement is notable, though sustainability depends on future quarters.

The company also describes its Emperor platform, an electromechanical evolution of the SynCardia Total Artificial Heart aimed at eventually enabling a fully implantable system using wireless power and internal control. Planned milestones include FDA Breakthrough Device pursuit, an IDE submission in 2028, and clinical study activities in 2029, tying the story to long-term execution in a highly regulated space.

Because timelines and regulatory outcomes are inherently uncertain, actual results will depend on successful preclinical work, FDA interactions, and continued commercialization of the current SynCardia technology. Subsequent filings and updates around the Emperor development milestones and revenue trends will help clarify how these ambitions translate into realized growth.

8-K Event Classification

Item 9.01 — Financial Statements and Exhibits

1 item

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Year-over-year revenue increase: 85% increase Gross margin: 28% U.S. revenue growth: 116% increase +3 more

6 metrics

Year-over-year revenue increase 85% increase Recent business performance highlighted in the presentation

Gross margin 28% From year-end 2025, as cited in the presentation

U.S. revenue growth 116% increase Increase in U.S. revenue driving overall results

SynCardia Total Artificial Heart implants More than 2,100 implants Performed at hospitals across 27 countries

Planned IDE submission timing 2028 Investigational Device Exemption for Emperor configuration

Planned clinical study timing 2029 Intent to begin clinical study activities for Emperor platform

Key Terms

Emerging growth company, Investigational Device Exemption, FDA Breakthrough Device designation, total artificial heart, +1 more

5 terms

Emerging growth company regulatory

"Emerging growth company 8.01: Other Events On July 2, 2026, Picard Medical, Inc."

An emerging growth company is a recently public or smaller public firm that qualifies for temporary, lighter regulatory and disclosure rules to reduce the cost and effort of being public. For investors, it means the company may provide less historical financial detail and face fewer reporting requirements than larger firms, so it can grow more quickly but also carries higher uncertainty—like buying a promising early-stage product with fewer user reviews.

Investigational Device Exemption regulatory

"a planned Investigational Device Exemption submission in 2028, and an intent to begin clinical study"

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.

FDA Breakthrough Device designation regulatory

"Development milestones for this initial configuration include pursuit of FDA Breakthrough Device designation, continued preclinical studies"

A FDA Breakthrough Device Designation is a U.S. regulatory status that gives certain medical devices faster and more flexible review because they may offer more effective treatment or diagnosis for unmet medical needs. Think of it as a “fast lane” through the regulatory process that can shorten development time and reduce regulatory uncertainty, which matters to investors because it can accelerate potential revenue, lower time-to-market risk, and make a product more attractive—while not guaranteeing final approval or commercial success.

total artificial heart medical

"maker of the world's first total artificial heart approved by both the U.S. Food and Drug Administration"

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.

forward-looking statements regulatory

"This press release includes 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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Picard Medical (PMI) disclose in its latest 8-K filing?

Picard Medical disclosed the release of a pre-recorded stockholder presentation ahead of its 2026 Annual Meeting, summarizing recent business performance, product development progress, manufacturing initiatives, and the proposals stockholders will consider and vote on during the virtual meeting.

How is Picard Medical (PMI) performing financially according to the presentation?

The presentation reports an 85% year-over-year increase in revenue, an improved gross margin of 28% from year-end 2025, and a 116% increase in U.S. revenue, indicating substantial recent growth in both topline performance and profitability metrics.

What is Picard Medical’s Emperor total artificial heart platform?

The Emperor platform is Picard Medical’s next-generation total artificial heart, using an Emperor Drive System to replace the current external pneumatic driver, with a roadmap toward a fully implantable system using wireless power transfer and internal control for end-stage heart failure patients.

What regulatory milestones does Picard Medical 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 an intent to begin clinical study activities in 2029, with scope and design determined in consultation with the FDA.

What proposals will Picard Medical stockholders consider at the 2026 Annual Meeting?

Stockholders will consider electing directors, proposed amendments to the company’s capital structure, ratification of its independent registered public accounting firm, and advisory votes on executive compensation, all outlined in the company’s presentation and proxy materials.

When and how will Picard Medical hold its 2026 Annual Meeting of Stockholders?

The 2026 Annual Meeting will be held virtually on Friday, July 17, 2026, at 6:00 p.m. Eastern Time, with stockholders of record able to vote by internet, telephone, or during the virtual meeting session.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 07/02/2026 - 08:15 AM

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): 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. ☐

8.01: Other Events

On July 2, 2026, Picard Medical, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the availability of a pre-recorded presentation (the “Presentation”) in advance of the Company's 2026 Annual Meeting of Stockholders, scheduled for July 17, 2026. A copy of each of the Press Release and Presentation is furnished as Exhibit 99.1 and Exhibit 99.2 and incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are being filed herewith:

Exhibit No.		Description
99.1		Press Release, dated July 2, 2026
99.2		Presentation, dated July 2, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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/ Richard Fang
	Name:	Richard Fang
	Title:	Interim Chief Executive Officer

Dated: July 2, 2026

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 2, 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 steady financial milestones including an 85% year-over-year increase in revenue and improved gross margin of 28% from year-end 2025, driven by a 116% increase of U.S. revenue 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

Exhibit 99.2