Supira Medical to initiate US clinical programme for pVAD system

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Gagan Singh, Susheel Kodali, and Azeem Latib with principal investigator Adrian Ebner, following the initial first-in-human cases with the Supira system in 2022

Supira Medical announced today that it has received US Food and Drug Administration (FDA) breakthrough device designation for its Supira percutaneous ventricular assist device (pVAD). The approval comes as the company closes US$40M in Series D financing and prepares to initiate its US clinical programme.

The financing was led by Cormorant Asset Management and The Capital Partnership (TCP), with participation from 415 CAPITAL, AMED Ventures, PA MedTech VC fund, Unorthodox Ventures and Shifamed angel investors. Funds will be used to expand Supira’s currently enrolling OUS studies, plan for its US studies, and prepare for US pivotal study submission.

“We are thrilled to have received breakthrough device designation and pleased to have the strong, continued support from our investors, both significant milestones for the company,” commented Nitin Salunke, president and CEO of Supira Medical. “Early clinical experience with the Supira system has demonstrated that physicians see tremendous clinical value in Supira’s low profile, high continuous flow design, including the system’s sensors intended to collect real-time aortic and ventricular pressures. I congratulate the team for engineering this differentiated solution that aims to provide a meaningful advantage for patients requiring haemodynamic support.”

“Although temporary mechanical circulatory support is common in the treatment of high-risk patients, challenges remain that limit physician adoption and patient access,” stated Bihua Chen, founder and managing member of Cormorant Asset Management. “We are pleased to lead this round and believe that Supira’s technology has the potential to disrupt the standard of care for the large and growing high-risk percutaneous coronary intervention (HRPCI) segment of the interventional cardiology market.”

 


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