Picard Celebrates Patient Living a World-Record of Over Eight Years with the SynCardia Total Artificial Heart

Rhea-AI Summary

Picard Medical (NYSE American: PMI) announced that a patient has reached 2,900 days (over eight years) of continuous support with the SynCardia Total Artificial Heart (STAH), the longest recorded time a person has lived on an artificial heart.

The company noted the STAH is the world’s first total artificial heart approved by both the U.S. FDA and Health Canada. Picard said the milestone highlights long-term durability and reliability of the STAH and that it is developing Emperor, a next-generation fully implantable artificial heart system to expand access to long-term support worldwide.

Positive

• 2,900 days of continuous STAH support (over eight years)
• STAH approval by U.S. FDA and Health Canada
• Development of Emperor next-generation fully implantable system

Negative

• None.

News Market Reaction – PMI

-8.71%

16 alerts

-8.71% News Effect

+16.8% Peak Tracked

-8.8% Trough Tracked

-$23M Valuation Impact

$236M Market Cap

0.3x Rel. Volume

On the day this news was published, PMI declined 8.71%, reflecting a notable negative market reaction. Argus tracked a peak move of +16.8% during that session. Argus tracked a trough of -8.8% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $23M from the company's valuation, bringing the market cap to $236M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

SynCardia support duration: 2,900 days Bridge financing principal: $1,000,000 Bridge note interest rate: 6% annually +5 more

8 metrics

SynCardia support duration 2,900 days Continuous support on SynCardia Total Artificial Heart

Bridge financing principal $1,000,000 Unsecured promissory note dated November 26, 2025

Bridge note interest rate 6% annually Interest on $1,000,000 unsecured promissory note

Q3 2025 revenue $1.187M Quarterly revenue, up from $0.881M year-ago

Q3 2025 net loss $10.426M Net loss for the quarter ended September 30, 2025

Cash balance $2.813M Cash as of Q3 2025 per 10-Q

Shares outstanding 73,701,176 shares Common stock outstanding as of November 10, 2025

IPO gross proceeds $19.5M Gross proceeds from IPO completed September 2, 2025

Market Reality Check

Price: $1.26 Vol: Volume 482,950 is below t...

low vol

$1.26 Last Close

Volume Volume 482,950 is below the 20-day average of 2,536,297, suggesting limited pre-news participation. low

Technical Shares trade below the 200-day MA of 2.69 with price at 2.47, indicating a prior downtrend.

Peers on Argus

PMI showed a gain of 3.05% while key peers were flat to modestly negative (e.g.,...

PMI showed a gain of 3.05% while key peers were flat to modestly negative (e.g., CTKB -0.6%, KIDS -2.96%, LAB -1.33%), pointing to a stock-specific move rather than a sector-wide shift.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Product durability milestone	Positive	-8.7%	Announced patient living over 2,900 days on SynCardia Total Artificial Heart.
Dec 03	Conference presentation	Positive	+2.0%	CEO scheduled to present Emperor Total Artificial Heart data at CSI Focus D-HF.
Nov 26	Conference data update	Positive	+1.9%	Planned in vitro Emperor Total Artificial Heart data presentation at ISMCS 2025.
Nov 19	Pre-clinical implantation	Positive	-6.7%	Reported first in vivo Emperor Total Artificial Heart implantations in pre-clinical models.
Nov 14	Earnings and IPO update	Positive	+10.7%	Q3 2025 results, IPO proceeds use, and patent news produced a strong positive move.

Pattern Detected

Recent positive operational and milestone updates often saw mixed reactions, with some events leading to gains (up to 10.66%) and others, including today’s milestone, seeing selloffs (down to -8.71%).

Recent Company History

Over the last month, Picard reported its Q3 2025 results on Nov 14, showing revenue growth and improved losses, which coincided with a 10.66% gain. Subsequent Emperor Total Artificial Heart development updates, including first in vivo implantations on Nov 19 and conference presentations on Nov 26 and Dec 3, drew modest price moves between about -6.69% and 2.02%. Today’s world‑record 2,900‑day SynCardia Total Artificial Heart support milestone continues that stream of technical and clinical progress news.

Market Pulse Summary

The stock moved -8.7% in the session following this news. A negative reaction despite today’s milest...

Analysis

The stock moved -8.7% in the session following this news. A negative reaction despite today’s milestone would fit prior divergence episodes, such as the -8.71% and -6.69% moves following otherwise constructive technical updates. The record 2,900‑day support result reinforces technology durability but arrives against a backdrop of ongoing losses and a stock trading well below its 52‑week high. Historical patterns show that positive news has sometimes coincided with selling pressure, highlighting execution and financing risks as ongoing considerations.

Key Terms

mechanical circulatory support, total artificial heart, bridge to transplant, u.s. fda, +2 more

6 terms

mechanical circulatory support medical

"marks a new milestone in the field of mechanical circulatory support with a patient"

Mechanical circulatory support are medical devices that help or take over the heart’s job of moving blood around the body, ranging from temporary external pumps to implanted pumps that assist one or both sides of the heart. For investors, these devices matter because their use drives sales, regulatory scrutiny, reimbursement decisions and long‑term healthcare costs; think of them as a backup engine for a failing heart whose adoption and outcomes influence a company’s market opportunity and risk profile.

total artificial heart medical

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

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 transplant medical

"offering not only a bridge to transplant but also durable long-term support"

A bridge to transplant is a temporary medical treatment or device used to keep a patient stable and alive while they wait for an organ transplant, such as a heart, lung, or liver. For investors, it signals a defined market for products and services that sustain patients during the waiting period—similar to a rental car keeping someone moving until their new car arrives—affecting demand, pricing, reimbursement and regulatory risk for related companies.

u.s. fda regulatory

"first total artificial heart approved by both the U.S. FDA and Health Canada"

The U.S. FDA is the federal agency that reviews and approves drugs, vaccines, medical devices and food products for safety and effectiveness before they can be sold in the United States. For investors, FDA actions act like a gatekeeper — approvals can open the door to large sales and higher company value, while rejections, delays or safety warnings can sharply cut a product’s market potential and a company’s revenue outlook.

health canada regulatory

"first total artificial heart approved by both the U.S. FDA and Health Canada"

Health Canada is the government department responsible for overseeing the safety and regulation of health-related products and services in Canada, including medications, medical devices, and vaccines. Its approval and guidelines help ensure that these products are safe and effective for public use. For investors, Health Canada's decisions can influence the success of healthcare companies and affect the availability of new medical treatments in the Canadian market.

fully implantable technical

"developing the Emperor, its next generation of fully implantable, artificial heart systems"

A fully implantable device is a medical or monitoring system placed entirely beneath the skin so there are no external pieces or wires visible or attached to the body. For investors, that matters because such designs tend to offer better patient comfort and lower infection risk but require more complex engineering, longer regulatory testing, and different service or replacement economics — all of which affect market potential, adoption speed, and long‑term revenue.

AI-generated analysis. Not financial advice.

-Picard Medical / SynCardia Systems LLC mark historic milestone as a patient reaches 2,900 days of continuous support with the SynCardia Total Artificial Heart -- the longest timeframe in the world ever recorded-

TUCSON, Ariz., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, proudly marks a new milestone in the field of mechanical circulatory support with a patient living over eight years or 2,900 days with a SynCardia™ Total Artificial Heart (STAH), the longest timeframe that a patient has ever lived on an artificial heart.

“This achievement shows the life-changing impact of the SynCardia Total Artificial Heart, offering not only a bridge to transplant but also durable long-term support, to support life far beyond the typical time span for patients waiting for a donor heart,” said Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical. “In this case, the STAH demonstrates long-term durability and reliability as well as fills a life-saving gap for patients who would otherwise have no viable options. Building on this foundation of long-term success, Picard Medical is now developing the Emperor, its next generation of fully implantable, artificial heart systems to broaden access and provide greater flexibility for long-term support worldwide.”

About the Patient

A 46-year-old patient, facing end-stage heart failure, received the SynCardia Total Artificial Heart on December 9, 2017 at the Institute for Cardiovascular Diseases, Dedinje hospital (also known as “IVDK Dedinje Hospital”) in Belgrade, Serbia. Today, eight years later, this patient continues to live supported by the SynCardia Total Artificial Heart, reaching more than 2,900 days of extended life, with most of those days spent at home with family and loved ones. The dedication of the medical team at IVDK Dedinje Hospital, combined with SynCardia’s technology, continues to make a profound difference in this patient’s journey.

Long-term Success Concentrated in Serbia

Serbia continues to lead the world in long-duration support with the SynCardia Total Artificial Heart. The five longest supported patients globally are all from IVDK Dedinje Hospital in Belgrade, with one patient supported for about eight years, another for more than four years, a third for more than three years, and two additional patients each supported for just under three years. These extraordinary cases reflect the strength of the clinical program in the region and the dedication of Serbian cardiac surgeons and transplant teams at IVDK Dedinje Hospital, who have advanced the SynCardia Total Artificial Heart at an exceptional level.

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 SynCardia Total Artificial Heart 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 at www.sec.gov.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. 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. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov.

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 milestone did Picard Medical (PMI) announce on December 9, 2025?

Picard announced a patient reached 2,900 days (over eight years) of continuous support with the SynCardia Total Artificial Heart.

How long has the longest-recorded SynCardia Total Artificial Heart (STAH) support lasted?

The longest recorded duration is 2,900 days, or more than eight years, of continuous STAH support.

Is the SynCardia Total Artificial Heart approved by regulators for use?

Yes; the STAH is approved by both the U.S. FDA and Health Canada.

What is Picard Medical developing after the STAH milestone?

Picard is developing Emperor, a next-generation fully implantable artificial heart system to broaden long-term support access.

What does the 2,900-day STAH milestone indicate for patients waiting for donor hearts?

Picard said the milestone demonstrates STAH can provide durable long-term support and an alternative for patients who lack viable donor options.

Where was Picard Medical when it announced the STAH world-record?

The announcement was issued from Tucson, Ariz. on December 9, 2025.