Picard Medical details growth and NYSE listing risk

Picard Medical, Inc. filed an 8-K to share a shareholder letter highlighting strong growth in its artificial heart business alongside ongoing financial and listing challenges.

Rhea-AI Filing Summary

Picard Medical, Inc. filed an 8-K to share a shareholder letter highlighting strong growth in its artificial heart business alongside ongoing financial and listing challenges. For 2025, total revenue reached $4.9 million, up 12.5%, with product revenue of $4.7 million representing 96% of the total. The company’s NYSE American IPO raised $17.4 million in net equity proceeds and it added $9.7 million of debt financing, ending 2025 with $11.5 million in cash versus $0.1 million a year earlier. In first-quarter 2026, revenue grew 85% to $1.2 million and gross margin swung to a positive 24% from a negative 58% a year before, while Picard repaid $7.4 million of senior secured debt principal in cash and settled $2.1 million through equity. The letter notes a 2025 going-concern qualification and explains steps taken in 2026, including a further $5.0 million public offering and capital structure simplification, as part of a roadmap toward profitability.

The company emphasizes its SynCardia Total Artificial Heart, the only FDA- and Health Canada-approved total artificial heart, with more than 2,100 implants across 27 countries. It is advancing the fully implantable Emperor TAH, which has completed initial animal testing and could be submitted for approval as early as 2028, subject to successful non-clinical work and regulatory review. Management also outlines plans to expand indications via an FDA premarket approval supplement, improve gross margins by scaling manufacturing toward 3,000 units per year, and submit a next-generation lower-cost driver for FDA review in late 2027. The letter discloses that NYSE American has raised concerns about stockholders’ equity; Picard has until June 7, 2026 to submit a compliance plan and is focused on maintaining its listing while continuing cost reductions, debt reduction, and growth initiatives.

Positive

• Rapid revenue and margin improvement: First-quarter 2026 revenue rose 85% to $1.2 million and gross margin improved to 24% from a negative 58% a year earlier, indicating better pricing, mix, or cost control.
• Strengthened liquidity and reduced debt: The company raised $17.4 million in IPO equity, $9.7 million in debt, and $5.0 million in a later offering, ended 2025 with $11.5 million in cash, and repaid or settled $9.5 million of senior secured debt.
• Clinically established, differentiated product: The SynCardia Total Artificial Heart is described as the only FDA- and Health Canada-approved total artificial heart, with more than 2,100 implants across 27 countries, supporting its clinical and commercial foundation.
• Pipeline with defined milestones: The Emperor Total Artificial Heart completed initial animal testing, and management targets FDA submission of a next-generation lower-cost driver in late 2027, providing clear R&D milestones tied to potential future growth.

Negative

• Going-concern qualification: The company’s 2025 financial statements include a going-concern qualification, highlighting uncertainty about its ability to continue operating without additional improvements and financing.
• NYSE American listing risk: NYSE American issued notices regarding stockholders’ equity requirements, and Picard must submit an acceptable compliance plan by June 7, 2026 to work toward maintaining its listing.
• Continuing losses and funding needs: Management states the company is not yet profitable and acknowledges ongoing needs to improve gross margins, reduce costs, and raise capital to support operations and regulatory programs.
• Regulatory and development uncertainty: Timelines for the Emperor Total Artificial Heart and next-generation driver depend on non-clinical results and regulatory review, and the company notes there can be no assurance on the timing or outcome of approvals.

Insights

Medical technology and small-cap equity analyst

Fast growth and de-leveraging offset by going-concern and listing risk.

Picard Medical reports 2025 revenue of $4.9 million and first-quarter 2026 revenue of $1.2 million, up 85% year over year, with gross margin improving from negative 58% to a positive 24%. The SynCardia Total Artificial Heart remains the only FDA- and Health Canada-approved total artificial heart, with more than 2,100 implants across 27 countries.

The company raised $17.4 million in IPO proceeds, $9.7 million in debt, and another $5.0 million through a public offering, ending 2025 with $11.5 million in cash versus $0.1 million in 2024. It repaid $7.4 million of senior secured principal and settled $2.1 million of debt in equity, while simplifying warrant terms, which collectively reduce balance sheet pressure.

Risks remain significant. Auditors issued a going-concern qualification for 2025, and NYSE American has notified the company about stockholders’ equity requirements, with a compliance plan due by June 7, 2026. Future value depends on achieving the profitability roadmap, securing FDA decisions on the premarket approval supplement and next-generation driver, and progressing the Emperor TAH toward a potential regulatory submission around 2028.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

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

Key Figures

2025 total revenue: $4.9 million Q1 2026 revenue: $1.2 million Q1 2026 gross margin: 24% +5 more

8 metrics

2025 total revenue $4.9 million Full-year 2025, up 12.5%

Q1 2026 revenue $1.2 million First quarter 2026, 85% growth year over year

Q1 2026 gross margin 24% Versus negative 58% gross margin in Q1 2025

IPO net equity proceeds $17.4 million Raised in NYSE American initial public offering

Debt repaid in cash $7.4 million Senior secured debt principal repaid in Q1 2026

Additional public offering $5.0 million Gross proceeds raised subsequent to Q1 2026

Heart transplants in U.S. 2024 4,572 procedures Compared to 4,545 in 2023, U.S. transplants

SynCardia TAH implants More than 2,100 implants Across 27 countries, cumulative use

Key Terms

going-concern qualification, premarket approval supplement, total artificial heart, bridge-to-candidacy patients, +2 more

6 terms

going-concern qualification financial

"While we are not yet profitable, and our auditors included a going-concern qualification in our 2025 financial statements"

An auditor's statement that raises substantial doubt about a company's ability to continue operating for the foreseeable future (typically the next 12 months) without major changes such as refinancing, restructuring, or new cash inflows. It matters to investors because it signals heightened risk to the firm's earnings, assets and cash flow — similar to a mechanic warning that a car may not run much longer unless fixed — and can affect stock value, credit terms and investor confidence.

premarket approval supplement regulatory

"We are awaiting an FDA decision on our pending premarket approval supplement, which would expand indications"

A premarket approval supplement is a regulatory submission seeking permission to change a medical device that already has FDA premarket approval, similar to asking a regulator for permission to alter a certified product before selling the new version. For investors, it matters because the supplement triggers a review that can affect how quickly a revised device reaches the market, add development or compliance costs, and change future sales or competitive positioning.

total artificial heart medical

"maker of the world’s first and only total artificial heart approved by both the U.S. FDA and Health Canada"

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.

bridge-to-candidacy patients medical

"expand indications to include bridge-to-candidacy patients and remove the “imminent death” language"

NYSE American listing standards regulatory

"the Company’s ability to submit a compliance plan acceptable to NYSE American and regain compliance with applicable listing standards"

NYSE American listing standards are the rules and requirements a company must meet to have its shares traded on the NYSE American exchange, covering minimum size, financial reporting, corporate governance and ongoing disclosure. Think of them as a marketplace’s entry and conduct rules: they help ensure a basic level of transparency, financial health and trading liquidity, which matters to investors because meeting those standards reduces information risk and the chance of sudden delisting or thin trading.

derivative liabilities financial

"converting certain convertible debt, eliminating derivative liabilities, and reducing financing-related complexity"

Derivative liabilities are obligations a company records when it owes money under financial contracts whose value depends on something else, like interest rates, stock prices, or currencies. Think of them as bets or insurance policies that can create future cash payments; they matter to investors because they can cause sudden changes in a company’s reported debt, profits and cash flow and reveal exposure to market risks that could affect valuation.

FAQ

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

What revenue did Picard Medical (PMI) report for 2025 and early 2026?

Picard Medical reported 2025 total revenue of $4.9 million, up 12.5%, with $4.7 million from products. In first-quarter 2026, revenue grew 85% year over year to $1.2 million, reflecting stronger commercial traction for its SynCardia Total Artificial Heart platform.

How is Picard Medical (PMI) improving its profitability and gross margins?

The company lifted first-quarter 2026 gross margin to 24% from a negative 58% a year earlier. Its roadmap includes reducing per-unit costs, scaling manufacturing capacity toward 3,000 units per year, and developing a next-generation lower-cost driver targeted for FDA submission in late 2027.

What financial steps has Picard Medical (PMI) taken to strengthen its balance sheet?

Picard Medical raised $17.4 million in net equity from its IPO, $9.7 million in debt financing, and a further $5.0 million in a public offering. It also repaid $7.4 million of senior secured debt in cash and settled $2.1 million of principal through equity.

What is the Emperor Total Artificial Heart and its expected timeline?

The Emperor Total Artificial Heart is Picard Medical’s fully implantable, driverless next-generation system. First-in-animal trials began in November 2025, and management indicates it may seek regulatory approval as early as 2028, subject to successful non-clinical testing and regulatory review.

What listing challenges does Picard Medical (PMI) face on NYSE American?

In May 2026, NYSE American notified Picard Medical about stockholders’ equity requirements. The company has until June 7, 2026 to submit a compliance plan and states it is taking steps to strengthen equity while remaining committed to maintaining its exchange listing.

How established is the SynCardia Total Artificial Heart clinically?

The SynCardia Total Artificial Heart is described as the only FDA- and Health Canada-approved total artificial heart for end-stage biventricular heart failure. It has been implanted more than 2,100 times across 27 countries, making it a widely used system in its category.

What are key risks highlighted by Picard Medical (PMI) in this update?

Key risks include a going-concern qualification in 2025 financial statements, dependence on raising additional capital, uncertainty around regulatory approvals for the Emperor TAH and next-generation driver, and the need to regain compliance with NYSE American listing standards related to stockholders’ equity.

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

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Accepted by SEC EDGAR 05/29/2026 - 07:05 AM EDT Learn about SEC filing dates

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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 29, 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. ☐

Item 7.01. Regulation FD Disclosure.

On May 29, 2026, Picard Medical, Inc. (the “Company”) issued a press release (the “Press Release”) featuring a letter from Richard Fang, Chairman of the Company’s Board of Directors, addressed to the Company’s stockholders. A copy of the Press Release is furnished as Exhibit 99.1 and incorporated by reference herein.

The information in this report and the exhibits attached hereto shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are being furnished herewith:

Exhibit No.		Description
99.1		Picard Medical, Inc. Press Release dated May 29, 2026
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/ Patrick NJ Schnegelsberg
	Name:	Patrick NJ Schnegelsberg
	Title:	Chief Executive Officer

Dated: May 29, 2026

2

Exhibit 99.1

PICARD MEDICAL, INC. Issues

Letter to Shareholders

TUCSON, Ariz., May 29, 2026 — Picard Medical, Inc. (NYSE American: PMI) (the “Company” or “Picard Medical”), parent company of SynCardia Systems LLC, maker of the world’s first and only total artificial heart approved by both the U.S. FDA and Health Canada, today issued the following letter to shareholders:

Dear Shareholders,

Picard Medical, Inc. (NYSE American: PMI) (“Picard Medical” or the “Company”), the parent company of SynCardia Systems LLC, is focused on advancing life-saving technologies for patients with end-stage heart failure while building long-term value for our shareholders. That mission continues to guide our strategy, and the progress we have made since 2025 — commercially, scientifically, and operationally — gives me confidence in the direction of the Company. I want to express my excitement in that direction by giving you a recap of our past accomplishments and our vision for the future.

A Transformational 2025 — and a Strong Start to 2026

2025 was a transformational year for the Company. Total revenue reached $4.9 million, up 12.5%, with product revenue of $4.7 million representing 96% of total revenue. Our initial public offering on NYSE American raised $17.4 million in net equity proceeds, and we raised an additional $9.7 million in debt financing, ending the year with $11.5 million in cash, compared to $0.1 million at year-end 2024.

We also took meaningful steps to strengthen and simplify our balance sheet by converting certain convertible debt, eliminating derivative liabilities, and reducing financing-related complexity.

That momentum has continued into 2026. First quarter revenue grew 85% to $1.2 million, and gross profit turned positive at a 24% margin, compared to a gross loss and negative 58% margin in the first quarter of 2025. During the quarter, the Company repaid approximately $7.4 million of senior secured debt principal in cash and settled an additional $2.1 million through equity. Subsequent to quarter end, we raised an additional $5.0 million in gross proceeds through a public offering and entered into a warrant exchange agreement that eliminated prior ratchet provisions and further simplified our capital structure.

While we are not yet profitable, and our auditors included a going-concern qualification in our 2025 financial statements, we believe the debt reduction, improved gross margins, and capital structure initiatives already achieved in 2026 represent meaningful progress toward addressing those issues.

Our Product — A Life-Saving Solution for Heart Transplant Patients

The SynCardia Total Artificial Heart (“SynCardia TAH”) is the only FDA- and Health Canada-approved total artificial heart for end-stage biventricular heart failure, with more than 2,100 implants performed across 27 countries, making it the most widely used and clinically established system of its kind globally (SynCardia Systems, LLC; PMI SEC filings). The SynCardia TAH continues to support patients at leading centers including UCSF, Cedars-Sinai, and Banner Health, and we are continuing to deepen those partnerships through dedicated clinical support and training.

The need for effective treatment options remains significant. According to the Organ Procurement and Transplantation Network (OPTN), more than 7,500 patients are currently on the U.S. heart transplant waiting list (OPTN/SRTR Annual Data Report 2022 – Heart). While 4,572 heart transplants were performed in the United States in 2024, compared to 4,545 in 2023, supply remains largely unchanged despite persistent demand growth (HRSA Organ Transplant News Release).

Many patients with end-stage biventricular heart failure will not receive a donor heart in time. For a portion of those patients, the SynCardia TAH may represent the only viable option for survival, and we intend to continue expanding patient access wherever possible.

The Emperor: Our Next-Generation, Fully Implantable Heart

Our research and development team continues to make encouraging progress on the Emperor TAH, our fully implantable, driverless, next-generation system. First-in-animal trials began in November 2025, and the Emperor TAH has achieved pulsatile flow rates consistent with our current SynCardia TAH platform. Earlier this year, we created improvements for a second-generation Emperor TAH and animal testing of this model was successfully completed last week. We expect to share additional information about this animal study in the near future.

The Emperor TAH is protected by multiple U.S. patents and a China National Intellectual Property Administration patent. Subject to successful non-clinical testing and regulatory review, we may seek approval as early as 2028, although the regulatory process is inherently unpredictable, and there can be no assurance regarding timing or approval outcomes.

Roadmap to Profitability

We remain focused on improving the Company’s financial performance and believe we have a clear path toward long-term sustainability through four primary initiatives:

Gross margin expansion. First quarter gross margin improvement to 24% is an important step forward. We intend to continue reducing per-unit costs, scaling manufacturing capacity toward 3,000 units per year, and advancing a next-generation lower-cost driver targeted for FDA submission in late 2027.

2

Operational efficiency. We are leveraging our R&D capabilities in Australia and expanding manufacturing partnerships to support a more responsive and efficient global supply chain.

Expanded indications. We are awaiting an FDA decision on our pending premarket approval supplement, which would expand indications to include bridge-to-candidacy patients and remove the “imminent death” language from the indications for use. We believe approval could materially expand the eligible patient population.

Commercial execution. Our sales and clinical teams continue to build relationships with high-volume transplant centers across the United States, with a focus on procedural readiness, clinical evidence, and patient outcomes.

NYSE American Listing

In May 2026, we received notices from NYSE American regarding stockholders’ equity requirements. We have until June 7, 2026 to submit a compliance plan, which we are actively preparing with our financial and legal advisors.

The Company has recently taken several steps intended to strengthen its balance sheet and improve stockholders’ equity, including completing an equity financing in May 2026, reducing outstanding liabilities through debt repayment and other settlements, implementing cost reduction initiatives, and continuing to focus on revenue growth and gross margin improvement.

We remain committed to maintaining our listing and acting in the long-term interests of our shareholders.

In Closing

Picard Medical stands at an important point in its development as both a medical technology company and a public company. We believe we are advancing technologies that have the potential to redefine treatment options for patients facing end-stage heart failure, while also building a stronger operational and financial foundation for the future.

Every SynCardia TAH implanted represents a patient given additional time and another opportunity for transplant or recovery. At the same time, every operational improvement, clinical milestone, and strategic investment is intended to strengthen the Company for the long term.

Your support and confidence are deeply appreciated. We remain committed to disciplined execution, scientific innovation, and creating lasting value for both patients and shareholders.

Sincerely,

Richard Fang, Ph.D., MBA

Chairman of the Board

Picard Medical, Inc. (NYSE American: PMI)

3

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 that 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 "believe," "expect," "intend," "may," "target," "commit," and similar expressions, and variations or negatives of these words.

These statements include, but are not limited to, statements regarding: the Company’s expectations regarding its path to profitability, including gross margin expansion, per-unit cost reductions, and scaling manufacturing capacity toward 3,000 units per year; the development, targeted timeline for FDA submission in late 2027, and commercial potential of a next-generation lower-cost driver; the Company’s intent to reach more patients and expand utilization of the SynCardia Total Artificial Heart at transplant centers across the United States; expectations regarding clinical partnerships at high-volume transplant centers and their impact on adoption; the development of the Emperor Total Artificial Heart, including expectations for sharing animal study data, seeking regulatory approval as early as 2028, and the inherent unpredictability of the regulatory process; the Company’s expectation of a decision from the FDA on its pending premarket approval supplement adding bridge-to-candidacy patients and the belief that approval would materially increase the eligible patient population; the Company’s roadmap to profitability, the Company’s plans to leverage R&D capabilities in Australia and expand manufacturing partnerships to build a more responsive global supply chain; the Company’s intent to submit a compliance plan to NYSE American by the applicable deadline and its commitment to maintaining its listing; the Company’s ability to regain compliance with NYSE American listing standards; and the Company’s belief that it is redefining what is possible for patients with end-stage heart failure.

Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements. These risks include, but are not limited to: the Company’s ability to achieve or maintain profitability; the Company’s ability to resolve the going-concern qualification in its financial statements; risks related to the development and regulatory approval of the Emperor Total Artificial Heart and the next-generation driver, including the possibility that regulatory approval may take longer than planned or may not be obtained at all; the Company’s ability to expand utilization of the SynCardia Total Artificial Heart and obtain FDA approval of its pending premarket approval supplement; the Company’s ability to reduce per-unit costs, scale manufacturing capacity, and improve gross margins; the Company’s ability to submit a compliance plan acceptable to NYSE American and regain compliance with applicable listing standards; and the Company’s ability to raise additional capital and maintain adequate liquidity.

4

The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. 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 on the SEC’s website at http://www.sec.gov and on the Company’s investor relations website at https://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

5

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 23.9 KB

Other Documents

• EX-101 XBRL SCHEMA FILE 2.9 KB
• EX-101 XBRL LABEL FILE 33.4 KB
• EX-101 XBRL PRESENTATION FILE 21.8 KB