Venus Medtech to Partner with Pi-Cardia to Bring its Leaflex(TM) Aortic Valve Technology to China

July 14,2020

Venus Medtech (Hangzhou) Inc. (stock code: 2500.HK), the leading transcatheter heart valve medical device player in China, and Pi-Cardia Ltd., a global leader in the development of non-implant catheter-based solutions for treating heart valve calcification, announced today a collaboration to bring Pi-Cardia's Leaflex™ technology to China.

Pi-Cardia's Leaflex™ catheter performs mechanical scoring of valve calcification, restoring leaflets' mobility and improving valve hemodynamics. The Leaflex™ catheter is designed to be a cost-effective, durable standalone treatment. It can be used for patients who are not planning 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 closed a US$27 million financing led by Sofinnova Partners, a leading European life sciences venture capital firm, following the successful completion of its First-in-Human studies, which demonstrated acute safety and feasibility. 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 its Leaflex™ technology, while concurrently continuing clinical trial activities in the United States and Europe. For Venus Medtech, this collaboration represents a bolstering of its portfolio of aortic valve products, enabling it to offer a unique non-implant based solution, the first of its kind in the world, to a rapidly growing Chinese market.

"We are excited to collaborate with Pi-Cardia to bringing its unique Leaflex™ aortic valve repair technology to Chinese patients," said Eric Zi, Co-Founder and Chief Executive Officer of Venus Medtech. "The global aortic valve market is expected to reach US$9 billion over the next few years, and we see a very steep growth in these procedures in China. Our ability to offer a lower cost non-implant based solution for patients with calcified aortic valves is an important complement to our Venus TAVR platform, especially since patients in China are required to pay out of pocket for these procedures. Our ability to offer a safe and effective catheter-based repair of their valve will be attractive to many patients: either to defer the need for TAVR, or as a cost-effective alternative to TAVR or SAVR."

"We are thrilled to work with a strong industry partner to make Leaflex™ a reality in China" said Erez Golan, Pi-Cardia's Chief Executive Officer and Founder. "With promising early clinical results, we are now ready to move to the next stage and establish the long term safety and efficacy of Leaflex™ as a standalone treatment for patients with aortic stenosis. We have an ambitious plan ahead of us, and we are dedicated to making Pi-Cardia's technology the next revolution in the treatment of structural heart disease."

"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," commented Academician Runlin Gao of Fuwai Hospital Chinese Academy of Medical Sciences and the National Center for Cardiovascular Diseases. Fuwai Hospital Chinese Academy of Medical Sciences is the world's largest cardiovascular center performing more than 75 thousand procedures each year. His colleague, Professor Yongjian 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."