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Picard Medical / SynCardia Highlights Total Artificial Heart Bridge to Transplant Case at Texas Children's Hospital

MWN-AI** Summary

Picard Medical, Inc. (NYSE American: PMI), the parent company of SynCardia Systems, LLC, recently showcased a significant success in using its SynCardia Total Artificial Heart (STAH) as a bridge to heart transplantation at Texas Children’s Hospital. This case involved 21-year-old Gregory, who initially received a heart transplant at the hospital in 2017 due to congenital heart defects. In early 2025, he faced heart rejection, and with a donor heart unavailable, surgeons turned to the STAH to provide essential circulatory support for about two and a half months until a suitable donor could be found.

The STAH is designed to replace the function of the ventricles in patients suffering from end-stage biventricular failure, demonstrating its flexibility and durability in managing complex clinical scenarios, including re-transplantation in young adults. Patrick NJ Schnegelsberg, CEO of Picard Medical, highlighted the complexity of the case, noting that the STAH was pivotal in stabilizing Gregory's condition while awaiting a donor heart.

In addition to celebrating this case, Picard Medical is advancing the development of the Emperor Total Artificial Heart, a next-generation fully implantable device meant to enhance access to long-term mechanical circulatory support without relying on external drivers. This development could significantly expand treatment options for critical patients.

Texas Children’s Hospital, both renowned for its pediatric care and a nonprofit institution, remains a leading research and care facility, displaying consistent excellence in treating complex cases. Picard Medical continues to strengthen its commitment to enhancing patient outcomes globally through its innovative heart technology, cementing its position as a leader in mechanical circulatory solutions.

MWN-AI** Analysis

Picard Medical, Inc. (NYSE American: PMI), the parent company of SynCardia Systems, has recently achieved a significant milestone with the successful utilization of the SynCardia Total Artificial Heart (STAH) at Texas Children's Hospital. This landmark case highlights the device's critical role in bridging patients to heart transplantation, reinforcing its value in the advanced heart failure market.

The case of Gregory, a 21-year-old patient who underwent a complex re-transplant journey, demonstrates the practical application of STAH in addressing the urgent need for circulatory support in critically ill individuals. Following the rejection of his first transplant, the timely intervention using the STAH allowed Gregory to stabilize until a suitable donor heart became available, underscoring the device’s potential impact on patient outcomes.

Investors should view this successful case as a positive indicator for Picard Medical. The company remains a leader in the total artificial heart domain, operating in a niche market with substantial growth potential. As more transplant centers adopt STAH for complex cases, global visibility and credibility for Picard Medical are likely to increase, bolstering its position among healthcare stakeholders.

Furthermore, Picard Medical’s commitment to advancing the Emperor Total Artificial Heart, a next-generation design aimed at removing external components, indicates its foresight in enhancing the treatment landscape for patients with advanced heart failure. This innovation could further expand market opportunities and improve patient access to life-saving technologies.

Despite these positive developments, potential investors should remain cautious. The medical device sector is susceptible to regulatory changes and market competition. Therefore, thorough due diligence, including review of the company’s financial condition and ongoing clinical outcomes, remains essential.

Overall, Picard Medical presents an appealing investment opportunity poised for growth, particularly in light of its pioneering advancements in heart failure treatment and its strategic partnerships with leading healthcare institutions.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

TUCSON, Ariz., April 15, 2026 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard Medical” 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, today highlighted the successful use of the SynCardia Total Artificial Heart (“STAH”) as a bridge to heart transplantation at Texas Children’s Hospital (“Texas Children’s”), supporting a 21-year-old patient through a complex re-transplant journey.

Texas Children’s recently featured the case of Gregory, a now 21-year-old patient who had received his first heart transplant at Texas Children’s in 2017 at the age of 13 following multiple congenital heart defects. In early 2025, Gregory was admitted to Texas Children’s after presenting with chest pain and was diagnosed with rejection of his first transplanted heart. With his original transplant no longer viable and a donor heart unavailable, surgeons implanted the STAH to provide full circulatory support. Gregory was supported on the STAH for approximately two and a half months before a suitable donor heart became available. He subsequently underwent successful heart transplantation and, following an extended recovery, was discharged from the hospital.

The STAH is designed to replace the function of both ventricles in patients with end-stage biventricular failure, enabling stabilization, organ recovery, and improved candidacy for transplantation. Its use in complex clinical scenarios, including re-transplantation in young adults with congenital heart disease, demonstrates the flexibility and durability of the therapy in supporting some of the most critically ill patients.

Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical, commented, “Performing a successful re-transplantation in a young adult with congenital heart disease is among the most complex scenarios in cardiac surgery. In this instance at Texas Children’s, the STAH allowed the clinical team to stabilize the patient and effectively buy time following the diagnosis of rejection until a suitable donor organ became available. Although the support period in this case was relatively short compared with many other cases, the immediate availability of the STAH was essential in enabling a successful outcome. Experiences like this also reinforce why we are developing the Emperor Total Artificial Heart, our next generation fully implantable total artificial heart, designed to remove the external driver and ultimately serve as a potential alternative to heart transplantation for certain patients.”

Picard Medical continues to support leading transplant centers across the United States and globally, advancing the use of the STAH to improve outcomes for patients with advanced heart failure. Picard is also advancing development of the Emperor Total Artificial Heart, a fully implantable next-generation device designed to expand access to long-term mechanical circulatory support without the need for external pneumatic drivers.

About Texas Children’s Hospital

Texas Children's, a nonprofit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The system includes the Texas Children's Duncan NRI; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston; and Texas Children's Hospital North Austin, the new state-of-the-art facility providing world-class pediatric and maternal care to Austin families. The organization also created Texas Children's Health Plan, the nation's first HMO focused on children; Texas Children's Pediatrics, the largest pediatric primary care network in the country; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that is channeling care to children and women all over the world. Texas Children's Hospital is affiliated with Baylor College of Medicine. For more information, visit www.texaschildrens.org.

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 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. 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


FAQ**

How does Picard Medical Inc. PMI plan to leverage the recent successful case of the SynCardia Total Artificial Heart at Texas Children’s Hospital to enhance its market position in advanced heart failure treatments?

Picard Medical Inc. aims to leverage the SynCardia Total Artificial Heart’s successful case at Texas Children’s Hospital by showcasing clinical outcomes to boost market visibility and credibility, while potentially driving partnerships and further innovations in advanced heart failure treatments.

What are the expected timelines for the development and commercialization of the Emperor Total Artificial Heart by Picard Medical Inc. PMI, and how might this impact the company's growth strategy?

The expected timelines for the development and commercialization of the Emperor Total Artificial Heart by Picard Medical Inc. are not publicly specified, but successful progression may significantly bolster the company's growth strategy through increased revenue and market presence in cardiovascular solutions.

Given the increasing use of the SynCardia Total Artificial Heart in complex scenarios, how is Picard Medical Inc. PMI addressing the potential expansion of applications for its technology in both pediatric and adult populations?

Picard Medical Inc. is actively exploring partnerships and research initiatives to expand the SynCardia Total Artificial Heart's applications for both pediatric and adult populations by enhancing its technology and addressing clinical needs through innovative solutions.

What steps is Picard Medical Inc. PMI taking to navigate the regulatory landscape and potential competition as it continues to advance its artificial heart technologies in the evolving healthcare market?

Picard Medical Inc. is actively engaging with regulatory bodies, conducting rigorous clinical trials, and establishing strategic partnerships to ensure compliance and innovation while addressing competitive pressures in the artificial heart technology sector.

**MWN-AI FAQ is based on asking OpenAI questions about Picard Medical Inc. (NYSE: PMI).

Picard Medical Inc.

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