Pi-Cardia Reports First Commercial Cases with ShortCut™

First dedicated leaflet modification solution to enable TAVR in patients at risk of coronary obstruction

Boston, Massachusetts March 3, 2025 — Pi-Cardia Inc., a global leader in the development of leaflet modification solutions for treating heart valves, announced today the first commercial procedures with ShortCut™ - the world's first dedicated leaflet modification device, enabling valve-in-valve (ViV) Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction. The news follows the ShortCut™ De Novo market clearance granted by the United States Food and Drug Administration (FDA) in September 2024.

The initial ShortCut™ procedures were successfully performed at various institutions including the Gagnon Cardiovascular Institute in Morristown, New Jersey by Dr. Philippe Généreux and Dr. Gennaro Giustino, at Cedars-Sinai Medical Center, Los Angeles, California by Dr. Raj Makkar and Dr. Wen Cheng, and at Piedmont Heart Institute, Atlanta, Georgia by Dr. Vinod H. Thourani and Dr. Pradeep Yadav.

“We are honored to have performed the first commercial ShortCut™ procedure and to be at the forefront of the innovative field of leaflet modification,” said Dr. Généreux. “In the past, treating this challenging patient population was possible mainly with surgical approaches or complex techniques. With ShortCut™, we safely split both the RCC and LCC leaflets in a simple, predictable, and controlled manner, enabling safe placement of a TAVR.”

“The ShortCut™ device is a true game changer, addressing one of the most significant challenges in structural heart.” said Dr. Makkar. “It will play a fundamental role in the lifetime management of aortic stenosis patients who may require multiple valve interventions. Given its quick and intuitive nature and seamless integration into the standard TAVR workflow, I am confident this tool will become highly adoptable across TAVR centers."

TAVR has become the preferred treatment for aortic stenosis, recently surpassing surgery even in patients younger than 65.1 As bioprosthetic valves degenerate over time, these patients will at some point likely need a valve-in-valve procedure to be performed, and a significant portion of them who are at risk for coronary obstruction will require leaflet splitting with ShortCut™.

"ShortCut™ is transforming the way we approach patients with aortic stenosis.” said Drs. Yadav and Thourani. “For intermediate- and high-risk patients who would have otherwise undergone surgery, it provides a reliable and predictable transcatheter option to prevent coronary obstruction. Thinking beyond the valve, we are now considering the necessary steps before implantation, as this will directly impact future treatment options for these patients."

Recently published models predict that by 2035, more than 40,000 valve-in-valve procedures will be performed annually in the U.S., representing more than 15% of all TAVR procedures.2 Future planned indication expansion into native and bicuspid valves may mean that around 30% of future TAVR cases will require leaflet modification with ShortCut™ in order to be performed safely and obtain optimal results for patients.

“We are incredibly proud of this significant milestone and are excited to pioneer the leaflet modification market,” said Erez Golan, Chief Executive Officer of Pi-Cardia. “The first week of U.S. launch demonstrated strong demand across the country for ShortCut™, with several leading hospitals treating patients successfully, and many other recognized institutes, including Tucson Medical Center, Kaiser San Francisco, Los Robles Regional Medical Center, University of Michigan, and Sentara Norfolk General Hospital, expected to join in the coming weeks. We continue to build our highly skilled field team and further increase manufacturing capacity as we partner closely with physicians and hospital systems to ensure they have access to ShortCut™.”

About Pi-Cardia

Pi-Cardia is a global leader in the development of a unique portfolio of non-implant, catheter-based, leaflet modification solutions for treating heart valves. The ShortCut™ device is a safe, simple and effective way to split valve leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction and is designed to preserve coronary access; ShortCut™ Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. The Leaflex™ device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics. Leaflex™ is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Additional leaflet modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. The Leaflex™ and ShortCut™ Mitral are investigational devices, limited by United States law for investigational use.

For more information, please visit: www.pi-cardia.net (http://www.pi-cardia.net)

For further information, contact:

Pi-Cardia

info@pi-cardia.net

SOURCE: Pi-Cardia Inc.

References

• O'Riordan, Michael. TCTMD, June 2024
• Généreux, Philippe., et al. Structural Heart Journal, July 2024