First U.S. Patient Successfully Treated with ShortCut

First Dedicated Leaflet Splitting Device To Facilitate Valve-in-Valve Procedures

REHOVOT, ISRAEL / December 21, 2022 / Pi-Cardia Ltd., focused on the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced that the first patient in the United States has been successfully treated with ShortCut™ - the world's first dedicated device designed to split the leaflets of a pre-existing valve to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk for coronary obstruction. Pi-Cardia received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to commence the ShortCut™ Pivotal Study in July 2022 and multiple patients have already been treated successfully outside the United States.

The ShortCut™ procedure was performed at Morristown Medical Center, New Jersey, US, by Drs - Philippe Généreux, Jim Slater, Leo Marcoff, and Robert Kipperman in collaboration with Dr. Benjamin Seguy. "We successfully treated this patient with a degenerated valve who was at risk of coronary obstruction after TAVR with the ShortCut™ device," said Dr. Généreux. "The targeted leaflet was effectively split within just a few minutes, allowing for safe implantation of the TAVR valve. ShortCut™ is a real game changer enabling TAVR treatment in younger patients who will likely need multiple interventions over the course of their lives".

The TAVR market, currently estimated at $6 billion, is projected to double over the next five years, with the expansion into low-risk younger patients. However, this growth may be hindered by a fundamental challenge: during TAVR implantation, the leaflets of the pre-existing valve are pushed sideways, in a way that may compromise future coronary access in some patients. This can turn into a life-threatening complication of complete coronary obstruction in a significant number of patients who undergo a second valve implantation when their previous bio-prosthetic valve degenerates. ShortCut™ may be used to split the pre-existing valve leaflets and is designed to prevent coronary obstruction, potentially enhancing the safety of valve-in-valve procedures and expanding the TAVR market.

"Lifetime management for patients with aortic stenosis is increasingly important as we use bioprosthetic valves more frequently in younger patients, and these valves degenerate over time," said Susheel K. Kodali, MD, Director of Structural Heart & Valve Center at New York Presbyterian/Columbia University Medical Center and US ShortCut™ Study Principal Investigator. "Often times, we may need to implant multiple valves in a patient, which may entail a risk of coronary obstruction or lack of access. The ShortCut™ device can simply split the leaflets of the previous degenerated valve and is designed to facilitate a safe TAVR."

ShortCut™ is part of Pi-Cardia's leaflet modification product portfolio, which includes the ShortCut™ Mitral for splitting leaflets in patients at risk for left ventricular outflow tract obstruction after TMVR, and Leaflex™, a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Leaflex™ global clinical trials are underway.

"We are very pleased with this milestone of commencing enrolment in the US, which allows us to move forward with our clinical plan towards commercialization in the US and Europe," said Erez Golan, Pi-Cardia's Chief Executive Officer. "Given the enthusiasm from US clinicians, we believe ShortCut™ can be the first dedicated leaflet splitting device coming to market as early as 2024."

About Pi-Cardia

Pi-Cardia is a global leader in the development of a unique portfolio of non-implant-based solutions for treating heart valves. Pi-Cardia's ShortCut™ device is designed to provide a safe, simple and effective way to split valve leaflets: ShortCut™ Aortic is designed to split leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction; ShortCut™ Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. Pi-Cardia's 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 ShortCut™ device and Leaflex™ device are investigational devices, limited by United States law for investigational use.

For more information, please visit: www.pi-cardia.net