Brings Extensive Experience from Medtronic Structural Heart to Launch TAVR-Enabling ShortCut™

Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it hired Gary Gratson to lead commercial operations for ShortCut™, the world's first dedicated leaflet modification device to enable Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of coronary obstruction. This announcement comes after completion of enrollment in the ShortCut™ Pivotal Study in the US and Europe in September 2023.

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Gary Gratson Vice President Commercial (Photo: Pi-Cardia)

Mr. Gratson comes with a wealth of experience in Medtronic Structural Heart where he has held various roles contributing to clinical, sales, marketing, operations and medical education, focused on effectively expanding the TAVR therapy. In his new role, Mr. Gratson will be responsible for building and leading the US commercial organization, driving strategic initiatives, and contributing to the continued growth of Pi-Cardia.

“This is a very exciting moment for us as we continue to move closer to commercializing ShortCut™”, said Erez Golan, Pi-Cardia's Chief Executive Officer. “Gary strengthens our leadership team by bringing extensive sales and marketing experience, as well as in depth domain expertise that will be key for building our strategy as a market leader".

"I am honored to join Pi-Cardia at such exciting times,” said Mr. Gratson. “I was fortunate to be part of a leadership team that over 15 years contributed to the growth of the TAVR market to a $6 billion business. Knowing the structural heart space from within, and based on multiple conversations with top physicians, I am confident that the key to further growth in TAVR is the availability of leaflet modification technologies, such as ShortCut™ and Leaflex™, that will offer a more wholistic approach to lifetime management. Pi-Cardia’s commitment to leading innovation in this space and improving patient outcomes is truly inspiring, and I look forward to working with the team to drive commercial success and contribute to the company's mission of advancing structural heart solutions."

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 following 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.

About Pi-Cardia

Pi-Cardia is a global leader in the development of a unique portfolio non-implant, catheter-based, leaflet modification 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 and may assist in preserving coronary access; 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

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