Pi-Cardia has closed a US$27 million round of financing, led by Sofinnova Partners. A press release reports that Pi-Cardia’s Leaflex catheter performs mechanical scoring of valve calcification, restoring leaflets’ mobility and improving valve haemodynamics. 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 a transcatheter aortic valve implantation (TAVI) and it can be a means to defer TAVI in patients who may be too young for the procedure.
According to the press release, the Leaflex catheter can also be a preparatory step for improving the outcome of TAVI in heavily-calcified and bicuspid aortic valves. Last year, Pi-Cardia successfully completed its First-in-Human studies, demonstrating acute safety and feasibility. The new financing will now enable the company to demonstrate the therapeutic effect of aortic valve scoring over time, through parallel clinical trials in the United States and Europe.
Anne Osdoit, partner at Sofinnova Partners, comments: “We are excited to join Pi-Cardia as an investor to help leverage the Leaflex in building a significant new market for aortic valve repair. The aortic valve market is expected to reach $9 billion over the next few years, and there is an ever-growing number of patients for whom physicians would prefer to avoid replacing the valve if they had a safe and effective way to defer disease progression.”
Erez Golan, Pi-Cardia’s CEO and founder, states: “Now, as we follow with admiration our fellow physicians and healthcare teams, working day and night to save lives in this COVID-19 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.”