Pi-Cardia Initiates First-in-Human Study With Novel Non-Implant Based Treatment of Aortic Stenosis

REHOVOT, Israel, May 16, 2018 /PRNewswire/ --

Pi-Cardia Ltd., announced today that it recently started its First-in-Human study with its Leaflex(TM) Performer catheter system. The Leaflex(TM) Performer is a trans-femoral catheter that uses two unique mechanical structures for scoring valve calcification at multiple locations, restoring leaflets flexibility and improving valve hemodynamics. The Leaflex(TM) catheter is aimed to be a cost-effective standalone treatment or a preparatory step for improving the outcome of valve implantation in heavily calcified aortic valves, bicuspid aortic valves and calcified mitral valves. Initial trial results demonstrate safety, feasibility and a hemodynamic improvement, which is significantly superior to that previously achieved with balloon valvuloplasty.

The design of the Leaflex(TM) Performer was based on the company's extensive research on calcium growth patterns in thousands of human aortic valves. Pi-Cardia's Leaflex(TM) technology and mechanism of action are fundamentally different from those 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(TM) scores the leaflets to create multiple targeted fractures at optimal locations of valve calcification thereby restoring leaflet mobility. This unique scoring 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-Cardia aims to expand the treatment options in the rapidly growing multi-billion dollar market currently dominated by surgical or trans-catheter aortic valve replacement (SAVR/TAVR). "As much as TAVR improves and becomes a routine procedure in lower surgical risk patients, it is still an implant with unknown durability, so in young patients taking a more conservative approach of using Leaflex(TM) to defer TAVR may make a lot of sense. TAVR is also an expensive procedure, which restricts its use to specific centers and specific cases," says Erez Golan, Pi-Cardia's Founder and CEO. "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 most patients."

"In a typical case of an eighty-five-year-old patient with a tri-leaflet aortic valve, we will simply have more options to offer, and there are also some common anatomies such as bicuspid aortic valves, where TAVR delivers suboptimal results," says Prof. Krzysztof Bartus who, together with Prof. Boguslaw Kapelak, performed the first-in-human cases with the Leaflex(TM) catheter at the Department of Cardiovascular Surgery and Transplantation, Jagiellonian University,  John Paul II Hospital in Krakow, Poland. "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 will present the Leaflex(TM) catheter system and initial clinical results at the EuroPCR meeting in Paris, in May 21-25, 2018, the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

About Pi-Cardia Ltd. 

Pi-Cardia is a global leader in the development of unique non-implant based solutions for treating valve calcification. Pi-Cardia's lead product, the Leaflex(TM) catheter system, is easily delivered and positioned on the valve, to then mechanically score the calcification at multiple locations, restoring leaflets flexibility and improving valve hemodynamics. The Leaflex(TM) catheter is aimed to be a cost-effective standalone treatment or a preparatory step for improving the outcome of valve implantation in heavily calcified aortic valves, bicuspid valves and calcified mitral valves.

        

        Contact: 
        Erez Golan 
        CEO 
        erez@pi-cardia.net 
        +972-8484800 

        Eyal Kolka 
        Executive Director 
        eyal@pi-cardia.net  

SOURCE Pi-Cardia Ltd.