Pi-Cardia

growth-positive

Pi-Cardia Ltd. has announced the successful First-In-Human treatment of the mitral valve with its ShortCut™ Mitral device in Europe. The device is designed to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after Transcatheter Aortic Valve Replacement (TAVR) or left ventricular outflow tract (LVOT) obstruction after Transcatheter Mitral Valve Replacement (TMVR). The company aims to treat more patients with mitral valve disease who have no other option. The TMVR market is growing exponentially and is predicted to reach several billion dollars in the next decade. Pi-Cardias product portfolio also includes the ShortCut™ Aortic and Leaflex™ devices, which are currently undergoing clinical trials in Europe.

growth-positive

Pi-Cardia Ltd. has received FDA approval to commence the ShortCut™ Pivotal Study for its dedicated leaflet splitting device designed to prevent coronary obstruction during Transcatheter Aortic Valve Replacement (TAVR). The TAVR market is projected to double over the next five years, and the ShortCut™ device aims to enhance the safety of valve-in-valve procedures and expand the market. The companys CEO, Erez Golan, believes that ShortCut™ can be the first dedicated leaflet splitting device in the US, coming to market as early as 2024. Pi-Cardia is also making progress in demonstrating the feasibility of its leaflet modification technologies, including the Leaflex™ device, which mechanically scores valve calcification to improve valve hemodynamics. The company sees significant additional market opportunities in treating bicuspid and mitral valves.

growth-positive

Pi-Cardia, a medical device company based in Rehovot, Israel, is developing innovative solutions for aortic valve stenosis. Their first product, Leaflex, aims to repair the aortic valve without replacing it with a prosthetic valve by breaking up calcification. The device is currently in human clinical trials in Europe and has received $27 million in funding led by Sofinnova Partners. Pi-Cardia has also signed a deal with Chinas Venus Medtech to test its products for the Chinese market. Their second product, ShortCut, is designed to split the leaflets of a previous prosthetic valve to ensure safer placement of a new one. Although not yet approved, ShortCut has already been used successfully in compassionate use cases. Pi-Cardia believes that both Leaflex and ShortCut could offer important new treatment options for aortic stenosis patients.

growth-positive

Israeli company Pi-Cardia Ltd. has collaborated with Venus Medtech to bring its Leaflex catheter-based solutions for treating heart valve calcification to China. The collaboration is expected to have a positive impact on Pi-Cardias growth. Pi-Cardias Leaflex catheter performs mechanical scoring of valve calcification, providing a cost-effective and durable standalone treatment. The catheter can be used for patients not planning to undergo transcatheter aortic valve replacement and can also be a preparatory step for improving the outcome of TAVR in heavily-calcified and bicuspid aortic valves. Pi-Cardia aims to establish the long-term safety and efficacy of Leaflex as a standalone treatment for patients with aortic stenosis.