PICARD MEDICAL, INC. Issues Letter to Shareholders
Rhea-AI Summary
Picard Medical (NYSE American: PMI), parent of SynCardia Systems, reported 2025 revenue of $4.9 million, up 12.5%, and year-end cash of $11.5 million. Q1 2026 revenue rose 85% to $1.2 million with a 24% gross margin, alongside significant debt reduction and balance-sheet simplification efforts.
The SynCardia Total Artificial Heart has surpassed 2,100 implants in 27 countries, and development continues on the fully implantable Emperor TAH. The company is addressing a going-concern qualification and NYSE American stockholders’ equity notices while pursuing a roadmap toward profitability.
AI-generated analysis. Not financial advice.
Positive
- 2025 total revenue reached $4.9 million, a 12.5% year-over-year increase
- Q1 2026 revenue grew 85% to $1.2 million with a 24% gross margin
- Year-end 2025 cash increased to $11.5 million from $0.1 million at 2024 year-end
- Approximately $7.4 million senior secured debt repaid in cash plus $2.1 million settled through equity
- More than 2,100 SynCardia Total Artificial Heart implants performed across 27 countries
Negative
- Company is not yet profitable and received a going-concern qualification in 2025 financial statements
- NYSE American issued stockholders’ equity deficiency notices; compliance plan due by June 7, 2026
- Future approval of the Emperor TAH is uncertain and subject to non-clinical testing and regulatory review
- Expanded indications for SynCardia TAH depend on pending FDA premarket approval supplement decision
News Market Reaction – PMI
On the day this news was published, PMI declined 1.67%, reflecting a mild negative market reaction. Argus tracked a peak move of +32.2% during that session. Argus tracked a trough of -3.5% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $235K from the company's valuation, bringing the market cap to $13.85M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner shows peers like OFIX, CTKB, and TMCI moving up, while PMI is flagged down, indicating stock-specific dynamics rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 21 | Earnings update | Negative | -8.4% | Q1 2026 results with strong growth but sizable loss and listing pressure. |
| May 05 | Equity offering | Negative | -40.4% | Approximately $5M best-efforts equity raise with warrants and dilution concerns. |
| Apr 30 | Clinical/commercial | Positive | -3.9% | Recognition of Banner Health as a leading SynCardia TAH implant center. |
| Apr 29 | Visibility/media | Positive | +5.6% | Interview series discussing total artificial heart therapy and Emperor platform. |
| Apr 22 | Earnings preview | Positive | +6.9% | Preliminary Q1 2026 revenue showing strong year-over-year growth. |
Recent financing and earnings releases often saw price declines, while clinical/commercial visibility updates skewed positive, suggesting sensitivity to dilution and balance sheet news.
Over the past six weeks, PMI has reported strong Q1 2026 revenue growth, multiple equity offerings, and ongoing clinical and commercial visibility for the SynCardia Total Artificial Heart. Earnings updates on Apr 22 and May 21 highlighted rapid top-line expansion but continued losses and listing risk. Offerings in early May coincided with sharp price drops, underscoring dilution concerns. Today’s shareholder letter reiterates many of these themes, including growth, debt reduction, and NYSE American compliance efforts, against a backdrop of historically volatile reactions to capital-raising news.
Market Pulse Summary
This announcement reiterates Picard Medical’s recent progress: 2025 revenue of $4.9 million, Q1 2026 revenue growth of 85%, and a shift to a 24% gross margin alongside meaningful debt repayment. It also highlights pipeline advances with the fully implantable Emperor Total Artificial Heart and potential indication expansion via an FDA premarket approval supplement. At the same time, investors must consider ongoing losses, going‑concern language, and NYSE American compliance deadlines when monitoring future financings and regulatory milestones.
Key Terms
total artificial heart medical
biventricular heart failure medical
pulsatile flow medical
premarket approval supplement regulatory
bridge-to-candidacy medical
imminent death regulatory
AI-generated analysis. Not financial advice.
TUCSON, Ariz., May 29, 2026 (GLOBE NEWSWIRE) -- 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
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
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
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)
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.
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
