Supira Medical’s pVAD Receives FDA Breakthrough Device Designation

November 21, 2023—Supira Medical, Inc., a Shifamed portfolio company, announced that it has received FDA Breakthrough Device designation for the Supira system, a next-generation percutaneous ventricular assist device (pVAD).

Additionally, the company advised that it has closed $40 million Series D financing as it prepares to initiate its United States clinical program. The funds will be used to expand Supira’s currently enrolling studies outside the United States, plan for its United States studies, and prepare for United States pivotal study submission.

According to the company, the Supira system features a low-profile, high continuous–flow design. The pVAD aims to provide full hemodynamic support initially for high-risk percutaneous coronary intervention and subsequently for cardiogenic shock patients with a single device platform. The 10-F profile is designed to minimize vascular complications, with multiple sensors to provide real-time pressure measurements.

The Supira system is for investigational use only and is not for sale in the United States or outside the United States, advised the company.

The financing was led by Cormorant Asset Management and The Capital Partnership, with participation from 415 Capital, Amed Ventures, PA MedTech VC fund, Unorthodox Ventures, and Shifamed angel investors.