#USA #FDA Approval #Corvia Medical #Tewksbury #heart failure treatment

Corvia Medical Secures $55 Million in Funding

Corvia Medical, Inc., a company dedicated to revolutionizing the treatment of heart failure, has successfully finalized a $55 million funding round with contributions from its existing investment syndicate. This group includes prominent investors such as Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, along with two strategic investors. The funds will be utilized to complete the ongoing RESPONDER-HF trial, a double-blind, randomized, sham-controlled confirmatory study of the Corvia® Atrial Shunt, currently being conducted across more than 65 institutions on three continents.

The RESPONDER-HF trial aims to provide crucial clinical data that will be necessary for the U.S. Food and Drug Administration (FDA) to approve the atrial shunt as an innovative treatment option for heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF).”

George Fazio, CEO of Corvia Medical, expressed gratitude towards their investors, stating, "We are deeply thankful for the unwavering support of our longstanding investors as we approach the FDA submission for the Corvia Atrial Shunt. Their commitment propels our mission to bring this transformative heart failure treatment to millions of patients worldwide."

Additionally, Paul LaViolette, Chair of the Board at Corvia Medical, noted, "We firmly believe that 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 navigate the approval process and introduce this innovative therapy to the market."

Understanding Heart Failure and the Corvia Atrial Shunt

Heart failure (HF) is a critical global health issue, affecting over 26 million people worldwide, with a majority diagnosed with HFpEF. This condition represents the largest unmet clinical need in cardiovascular medicine today. The Corvia Atrial Shunt is engineered to reduce elevated left atrial pressure (LAP), a key contributor to heart failure symptoms, by creating a connection between the left and right atria. This mechanism decreases heart failure episodes and potentially enhances the quality of life for patients.

The FDA recognized the Corvia Atrial Shunt as a Breakthrough Device in 2019, reflecting its promising potential in treating heart failure. For more information about eligibility for the RESPONDER-HF study, visit treatmyheartfailure.com.

About Corvia Medical, Inc.

Founded in 2009 and headquartered in Tewksbury, Massachusetts, Corvia Medical, Inc. is at the forefront of transforming heart failure treatment through innovative transcatheter cardiovascular devices. The company is devoted to changing the standard of care and helping patients reclaim their lives by advancing effective heart failure therapies. More insights can be found at corviamedical.com.

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