Pi-Cardia pulls in $10m for Leaflex aortic valve catheter

Stalthy Pi-Cardia said today that it raised $10 million from a consortium that includes a mystery strategic investor for its Leaflex treatment for aortic stenosis.

Rehovot, Israel-based Pi-Cardia’s Leaflex is a catheter-based procedure designed to use mechanical energy to crack the calcification on aortic valve leaflets to return them to normal function. The company said that Italian funds Innogest and Fondo Atlante Ventures, China’s VI-Ventures and existing backers also participated in the round, including Clal Biotechnology Industries and Anatomy Medical Technologies Fund.

“As much as [transcatheter aortic valve replacement] improves and becomes a routine procedure in lower surgical risk patients, it is still a relatively complex and expensive implantation procedure, which restricts its use to specific centers and specific cases,” founder & CEO Erez Golan said in prepared remarks. “In today’s budget sensitive environment, waiting lists for TAVR are common even in the most developed countries, let alone in emerging markets, where TAVR may not be a viable option for a while.”

“Besides the typical case of an 85-year-old patient with a tri-leaflet aortic valve, whom I will simply have more options to offer, there are also some common anatomies such as bicuspid aortic valves, where TAVR delivers suboptimal results,” added Dr. Ganesh Manoharan of Belfast’s Royal Victoria Hospital. “We believe that if a simpler, lower-cost alternative existed, which could offer patients a reasonable period of time without symptoms, such a technique could have an important role alongside TAVR.”

Pi-Cardia said it closed enrollment last year for the 1st set of patients in a European safety & feasibility trial for Leaflex and plans to use the new funding to complete the development of a 2nd-generation device and pay for ongoing clinical trials aimed at winning CE Mark approval in the European Union.

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