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April 20, 2020

Financing Will Support Clinical Trials for Pi-Cardia’s Leaflex Aortic Valve Technology

April 20, 2020—Pi-Cardia Ltd., an Israel-based developer of nonimplant catheter-based solutions for treating heart valve calcification, announced it has closed a $27 million round of financing that will support clinical investigations of the company’s Leaflex catheter.

According to the company, the Leaflex catheter performs mechanical scoring of valve calcification, restoring leaflets’ mobility and improving valve hemodynamics. The device can be used for patients who are not planning to undergo transcatheter aortic valve replacement (TAVR) and can be a means to defer TAVR in patients who may be too young for the procedure. It can also be a preparatory step for improving the outcome of TAVR in heavily calcified and bicuspid aortic valves.

In 2019, Pi-Cardia completed its first-in-human studies, which demonstrated the device’s acute safety and feasibility. The new financing will enable the company to conduct parallel clinical trials in the United States and Europe to demonstrate the therapeutic effect of aortic valve scoring over time.

The financing was led by Sofinnova Partners, a European life sciences venture capital firm, and joined by Professor Jacques Séguin, MD, Chairman of the company, with further participation from existing investors.

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