Advertisement

July 14, 2020

Venus Medtech to Bring Pi-Cardia’s Leaflex Aortic Valve Technology to China

July 14, 2020—Venus Medtech (Hangzhou) Inc., a China-based transcatheter heart valve medical company, and Pi-Cardia Ltd. announced a collaboration to bring Pi-Cardia’s Leaflex technology to China. Headquartered in Israel, PiCardia is a focused on nonimplant, catheter-based solutions for treating heart valve calcification.

According to the companies, Pi-Cardia’s Leaflex catheter performs mechanical scoring of valve calcification, restoring leaflet mobility and improving valve hemodynamics. The device is designed to be a cost-effective, durable, standalone treatment. It can be used for patients who are not planing to undergo transcatheter aortic valve replacement (TAVR), and it can be a means to defer TAVR in patients who may be too young for the procedure. It can also be a preparatory step for improving the outcome of TAVR in heavily calcified and bicuspid aortic valves.

In April, Pi-Cardia announced the closing of a $27 million round of financing led by Sofinnova Partners. The financing came after the successful completion of the first-in-human studies demonstrating acute safety and feasibility of the Leaflex catheter.

The strategic agreement with Venus Medtech will enable Pi-Cardia to pursue its global expansion by working with the market leader in China on clinical trials, manufacturing, and commercializing of the Leaflex technology, while concurrently continuing clinical trial activities in the United States and Europe. With the collaboration, Venus Medtech will bolster its portfolio of aortic valve products, enabling it to offer a nonimplant-based solution.

Runlin Gao, MD, and Professor Yongjian Wu, MD, of Fuwai Hospital Chinese Academy of Medical Sciences, commented on the collaboration of the companies. Fuwai Hospital Chinese Academy of Medical Sciences is the world’s largest cardiovascular center performing more than 75,000 procedures each year.

Dr. Gao stated, “With large numbers of lower-income aortic stenosis patients in China, the Leaflex technology could provide treatment possibilities to an otherwise overlooked and undertreated sector.” Professor Wu added, “We believe that the Leaflex system may also hold the promise of restoring leaflet mobility in calcified prosthetic valves and could be a viable alternative to future valve-in-valve procedures.”

Advertisement


July 14, 2020

FDA Grants Breakthrough Designation for Revamp Medical’s Doraya Catheter

July 14, 2020

Penumbra Appoints Medical and Scientific Leadership