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

(Very Positive)
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Picard Medical (NYSE American: PMI), parent of SynCardia, released a pre-recorded stockholder presentation ahead of its virtual 2026 Annual Meeting on July 17, 2026. The presentation reviews recent business performance, including an 85% year-over-year revenue increase for the first three months of 2026, driven by a 116% rise in U.S. revenue, and a gross margin of 24% versus -4% in 2025.

Picard Medical outlines manufacturing optimization efforts and development of its next-generation Emperor platform, which replaces the external pneumatic driver with an electromechanical actuation system and targets a fully implantable total artificial heart. Milestones include pursuit of FDA Breakthrough Device designation, continued preclinical studies, a planned IDE submission in 2028, and intended clinical study activities in 2029.

The presentation also summarizes proposals for stockholder vote: election of directors, amendments to the capital structure, auditor ratification, and advisory votes on executive compensation. Stockholders of record may vote online, by phone, or during the virtual meeting.

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Positive

  • Revenue +85% YoY in first three months of 2026, with U.S. revenue up 116%
  • Gross margin improved to 24% for early 2026 from -4% in 2025
  • Clear development roadmap for Emperor platform including IDE submission targeted for 2028
  • Manufacturing optimization initiatives aimed at quality, supply chain resilience, and cost reduction

Negative

  • Gross margin at 24% remains modest despite improvement from 2025
  • Key Emperor platform milestones, including clinical study activities, not planned until 2029
  • Capital structure amendments and compensation advisory votes may introduce governance uncertainties for some investors

Market reaction after 2026 annual meeting presentation: PMI -7.47% in the Jul 13 session

-7.47% 78.1x vol
209 alerts
-7.47% Session close to close
+71.2% Peak Tracked
-9.7% Trough Tracked
$17.25M Market Cap
78.1x Rel. Volume

In the Jul 13 session, PMI declined 7.47%, reflecting a notable negative market reaction. Argus tracked a peak move of +71.2% during that session. Argus tracked a trough of -9.7% from its starting point during tracking. Our momentum scanner triggered 209 alerts that day, indicating exceptionally high trading interest and price volatility. Trading volume was exceptionally heavy at 78.1x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -7.5% in the session following this news. A pronounced selloff could indicate concer...
Analysis

The stock moved -7.5% in the session following this news. A pronounced selloff could indicate concern that, despite 85% revenue growth and a 24% gross margin, longer-dated Emperor TAH milestones to 2028–2029 dominate sentiment. Past reactions to routine updates have often skewed mildly negative, with limited short-covering support.

Key Figures

Revenue growth: 85% year-over-year U.S. revenue growth: 116% increase Gross margin: 24% +5 more
8 metrics
Revenue growth 85% year-over-year First three months of 2026
U.S. revenue growth 116% increase First three months of 2026
Gross margin 24% First three months of 2026
Gross margin -4% Full year 2025
IDE submission timing 2028 Planned Investigational Device Exemption submission
Clinical study start 2029 Planned start of clinical study activities
Annual meeting date July 17, 2026 2026 Annual Meeting of Stockholders
Meeting time 6:00 p.m. Eastern Time 2026 Annual Meeting of Stockholders

Historical Context

5 past events · Latest: Jul 02 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 02 Stockholder presentation Positive -1.6% Pre-recorded annual meeting presentation with strong Q1 growth and margin improvement.
Jun 24 Leadership transition Neutral -2.5% CEO resignation and appointment of board chair as interim chief executive.
Jun 16 Conference presentations Positive -3.9% Planned in vivo Emperor TAH data and SynCardia patient outcomes at ASAIO 2026.
Jun 02 Preclinical data update Positive +60.3% Successful acute in vivo animal implants of next‑generation Emperor total artificial heart.
May 29 Shareholder letter Neutral -1.7% Full-year 2025 results, Q1 2026 growth, and going-concern and listing compliance discussion.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

News on substantial Emperor Total Artificial Heart progress has coincided with the only strong positive move, while other business and governance updates have typically seen modest negative reactions.

Key Terms

total artificial heart, gross margin, fda breakthrough device designation, investigational device exemption
4 terms
total artificial heart medical
"maker of the world's first total artificial heart approved by both the U.S."
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.
gross margin financial
"Gross margin was 24% for the same period."
Gross margin is the difference between how much money a company makes from selling its products and how much it costs to produce them, expressed as a percentage of sales. It shows how efficiently a company is turning sales into profit before other expenses like marketing or salaries. Higher gross margin means the company keeps more money from each sale, which is a good sign of financial health.
View in glossary
fda breakthrough device designation regulatory
"Development milestones for this initial configuration include pursuit of FDA Breakthrough Device designation,"
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.
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.

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

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

TUCSON, Ariz., July 13, 2026 (GLOBE NEWSWIRE) -- 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


FAQ

What key financial results did Picard Medical (PMI) highlight in its 2026 stockholder presentation?

Picard Medical reported an 85% year-over-year revenue increase for the first three months of 2026, driven by 116% U.S. revenue growth. According to Picard Medical, gross margin improved to 24% for the same period, compared with -4% in 2025, indicating significantly better profitability metrics.

How is Picard Medical advancing the SynCardia Emperor total artificial heart platform?

Picard Medical is developing the Emperor platform using an electromechanical drive system to replace the external pneumatic driver. According to Picard Medical, the initial configuration uses an external controller and battery, with a longer-term roadmap toward a fully implantable system using wireless power transfer and internal control.

What regulatory and clinical milestones are planned for the Emperor platform at Picard Medical (PMI)?

Picard Medical plans to pursue FDA Breakthrough Device designation, continue preclinical studies, and submit an IDE in 2028. According to Picard Medical, it also intends to begin clinical study activities in 2029, with scope and design determined in consultation with the FDA.

When is the Picard Medical 2026 Annual Meeting of Stockholders and how can PMI investors vote?

The 2026 Annual Meeting will be held virtually on July 17, 2026, at 6:00 p.m. Eastern Time. According to Picard Medical, stockholders of record as of the applicable record date may vote by internet, telephone, or during the virtual meeting session.

What proposals will Picard Medical (PMI) stockholders vote on at the 2026 Annual Meeting?

Stockholders will vote on electing directors, proposed amendments to the capital structure, auditor ratification, and advisory votes on executive compensation. According to Picard Medical, these items are detailed in the company’s proxy materials, which stockholders are encouraged to review before submitting their votes.

How is Picard Medical addressing manufacturing and cost structure for SynCardia products?

Picard Medical described manufacturing optimization initiatives to enhance quality control, strengthen supply chain resilience, and reduce production costs. According to Picard Medical, these efforts support both current SynCardia total artificial heart products and future platforms like Emperor, aiming to improve operational efficiency over time.