Pi-Cardia Receives FDA IDE Approval for Pivotal Study with ShortCut(TM) Device

First Dedicated Leaflet Splitting Device Designed to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement

REHOVOT, ISRAEL / ACCESSWIRE / July 26, 2022 / Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to commence the ShortCut™ Pivotal Study, which will assess the safety and effectiveness of the ShortCut™ device. ShortCut™ is 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.

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 which 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 bio-prosthetic 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. "When we then need to implant a second or third valve in a patient, the ShortCut™ device can simply split the leaflets of the previous valve and is designed to facilitate a safe TAVR. Procedures performed to date outside the US demonstrate that ShortCut™ was able to effectively split the leaflets within minutes, allowing for a safe implantation of both self-expandable and balloon-expandable TAVR valves. We are so excited to join our European colleagues and start enrolling patients in the US soon."

ShortCut™ is part of the Pi-Cardia's product portfolio, which includes the Leaflex™ device - a standalone, non-implant-based treatment for patients with aortic stenosis. Leaflex™ performs mechanical scoring of valve calcification and is designed to restore leaflet mobility and improve hemodynamics. Leaflex™ global clinical trials are underway.

"The IDE approval of the ShortCut™ Pivotal Study represents a major milestone, which allows us to now 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 in the US, coming to market as early as 2024. At the same time, we are making great progress demonstrating the feasibility of our leaflet modification technologies, namely ShortCut™ and Leaflex™, in enabling treatment of bicuspid valves and mitral valves. Each of these future indications represent a significant additional market opportunity for Pi-Cardia".

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 the leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary 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. Both leaflet modification technologies could further be used to expand treatment options in bicuspid and mitral valves. The ShortCut™ device and Leaflex™ device are investigational devices, limited by United States law for investigational use.

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Erez Golan
CEO

Eyal Kolka
Executive Director

SOURCE: Pi-Cardia Ltd.