Supira Medical, Inc. , a Shifamed portfolio company, announced today that it has received U.S. Food and Drug Administration (FDA) breakthrough device designation for its Supira System, a next-generation percutaneous ventricular assist device (pVAD).
| LOS GATOS, Calif., Nov. 21, 2023 /PRNewswire/ -- Supira Medical, Inc., a Shifamed portfolio company, announced today that it has received U.S. Food and Drug Administration (FDA) breakthrough device designation for its Supira System, a next-generation percutaneous ventricular assist device (pVAD). This approval comes as the company closed $40M in Series D financing and prepares to initiate its U.S. clinical program. 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 U.S. studies, and prepare for U.S. pivotal study submission.
“We are thrilled to have received breakthrough device designation and pleased to have the strong, continued support from our investors.” “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 Dr. 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 hemodynamic 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 HRPCI segment of the interventional cardiology market.” About the Supira System The Supira System is for Investigational Use Only and is not for sale in the U.S. or outside the U.S. About Supira Medical, Inc. MEDIA CONTACT:
SOURCE Supira Medical, Inc. |
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