Atlante Ventures, the fund of the Intesa Sanpaolo group dedicated to venture capital, and Innogest, currently the largest Venture Capital firm in Italy focused on seed and early-stage ventures with more than €170 million under management, announced their participation to a $10 million investment round on Pi-Cardia Ltd, an Israeli medical device start-up company developing a novel low profile catheter for the treatment of aortic stenosis. Backers include also Chinese fund VI-Ventures and existing investors Clal Biotechnology Industries Ltd, the largest life sciences holding company in Israel, and Anatomy Medical Technologies Fund. The main part of the investment has been completed by a new strategic investor who has remained anonymous, but it would be a big corporate venture abroad.
Pi-Cardia, founded in 2009, has headquarters in the Israeli city of Rehovot, where it developed the Leaflex Catheter System, a novel non-implant innovative based technology for treating of patients with aortic valve stenosis. The Leaflex is a low-profile trans-femoral catheter incorporating unique Nitinol elements, which are optimized for delivering mechanical energy to create substantial fractures in valve calcification. These fractures help restore the mobility of the tissue and to improve valve hemodynamics using a short and simple procedure without the need to implant a new valve.
The design of Leaflex was based on the company's extensive research in the last few years on calcium growth patterns in hundreds of human aortic valves. Pi-cardia's Leaflex technology and mechanism of action are fundamentally different from thos of balloon-based (BAV) devices, in that instead of simply dilating the valve, which might lend itself to the short-term recoil seen in patients treated with BAV, the Leaflex creates multiple targeted fractures at optimal locations of valve calcifications thereby restoring leaflet mobility. This unique fracturing method, while preserving the native valve integrity, may facilitate valve replacement therapies, as well as pave the way for providing durable treatment without implanting a new valve.
Pi-Cardias aims to expand the treatment options in the rapidly growing multi-billion dollar amrket currently dominated by surgical or trans-catheter aortic valve replacement (SAVR/TAVR).
It is a rare case in which the two Italian funds invest on foreign startups that point on Italy. Indeed, Pi-Cardia wants to invest in Italy. The goal is to receive the CE mark that allows to market the product in Europe and launch a pilot clinical trial in the United States. And to manage this process, the Israeli startup plans to create a research center in Italy, probably in Lombardy, from which it will coordinate all the clinical, regulatory and business development activities in Europe. In 2015, Pi-Cardia successfully completed enrolling the first set of patients in its FIM study in Europe, demonstrating safety and feasibility of the procedure. The funds raised would allow the company to complete the development of a second generation device, and to continue the clinical studies for showing its safety and performance, towards CE-mark.
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