Salute e Benessere
Corvia Medical closes $55 million funding round to complete confirmatory trial and pursue FDA approval of Corvia Atrial Shunt
The funds will be used to complete the ongoing RESPONDER-HF trial, a double-blinded, randomized, sham-controlled, confirmatory trial of the Corvia Atrial Shunt currently underway at more than 65 institutions on three continents. The study is expected to generate the final supportive clinical data required for FDA approval of the shunt as a breakthrough treatment for heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF).
"We are profoundly grateful for the unwavering support of our longstanding investors as we advance toward FDA submission of the Corvia Atrial Shunt," said George Fazio , CEO of Corvia Medical. "Their commitment furthers our mission to bring this transformative heart failure treatment to millions of patients worldwide."
Paul LaViolette , Board Chair of Corvia Medical, added, "We firmly believe Corvia has the potential to fundamentally alter the landscape of heart failure treatment, and our investors share that vision. With these resources, we are well-equipped to drive the company through the approval process and introduce this groundbreaking therapy to the market."
More than 26 million people worldwide have HF, and the majority have HFpEF, making it the largest unmet clinical need in cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated left atrial pressure (LAP), the primary contributor to HF symptoms, by creating a passage between the left and right atria, reducing HF events and improving quality of life. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. For information regarding RESPONDER-HF study eligibility, please visit https://treatmyheartfailure.com.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA , privately-held Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. Visit https://corviamedical.com.
Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com
View original content:https://www.prnewswire.co.uk/news-releases/corvia-medical-closes-55-million-funding-round-to-complete-confirmatory-trial-and-pursue-fda-approval-of-corvia-atrial-shunt-302483319.html