Pi-Cardia is engaged in the development of non-implant catheter-based solutions, intended for the treatment of heart valve calcification
Israel-based medical device start-up Pi-Cardia has closed a $27m financing round, led by Sofinnova Partners, a France-based venture capital firm, to continue clinical trials on its Leaflex aortic valve technology.
The financing round also saw participation from professor Jacques Séguin, chairman of the company, and existing investors.
Pi-Cardia is engaged in the development of non-implant catheter-based solutions, intended for the treatment of heart valve calcification.
Leaflex can be easily delivered and positioned on the valve to score the calcification
Pi-Cardia’s lead product, the Leaflex Performer catheter, has been designed to be a cost-effective, durable standalone treatment to improve the outcome of valve implantation in heavily calcified aortic valves, and in bicuspid aortic valves.
The catheter can be easily delivered and positioned on the valve to mechanically score the calcification at multiple locations, and restore leaflets flexibility to improve valve hemodynamics.
In addition, Leaflex can be used for patients who are not planning to undergo a transcatheter aortic valve replacement (TAVR) and can be used to defer TAVR in patients who may be too young for the procedure.
Pi-Cardia has completed the first-in-human studies, which showed safety and feasibility of the catheter.
The latest funding will enable the company to demonstrate the therapeutic effect of aortic valve scoring over time, through parallel clinical trials in the US and Europe.
Pi-Cardia CEO and founder Erez Golan said: “Now, as we follow with admiration our fellow physicians and healthcare teams, working day and night to save lives in this Covid19 crisis, we are ever more committed to driving healthcare innovation forward.
“With our very promising early 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.”