CORVIA MEDICAL ANNOUNCES RANDOMIZATION OF FIRST PATIENT IN THE RESPONDER-HF CONFIRMATORY TRIAL

Corvia^® Atrial Shunt has the potential to change the way heart failure is treated

TEWKSBURY, Mass., Dec. 6, 2022 /PRNewswire/ -- Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), announced the first patient has been randomized in RESPONDER-HF, a global confirmatory trial of the Corvia Atrial Shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

The first patient was enrolled and randomized by Scott Lilly, M.D., Interventional Cardiologist, and Rami Kahwash, M.D., Heart Failure Cardiologist at the Ohio State University Wexner Medical Center. "We are pleased to participate in RESPONDER-HF and continue the important work of studying atrial shunt therapy, which may represent significant clinical benefit for millions of heart failure patients," commented Dr. Lilly.  Dr. Kahwash added, "Despite ongoing pharmaceutical advances, the treatment of HFpEF remains challenging, and multiple therapies are needed to treat such a heterogenous disease. We are pleased to offer access to a novel treatment option that has the potential to relieve our patients' breathlessness and improve their quality of life."

RESPONDER-HF is a randomized, sham-controlled trial including up to 260 patients from 60 centers across the US, Europe, and Australia. The trial will evaluate the efficacy of the Corvia Atrial Shunt to reduce HF hospitalizations and improve quality of life (QoL). Sanjiv Shah, M.D., Director of Research for the Bluhm Cardiovascular Institute, and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, and Martin Leon, M.D., Director of Interventional Cardiovascular Care at Columbia University Irving Medical Center, serve as lead investigators for the study.

The RESPONDER-HF confirmatory trial builds on extensive scientific data and progressive learnings from REDUCE LAP-HF II, the largest randomized controlled trial of a device-based therapy for HFpEF patients. As published in Circulation,¹ REDUCE LAP-HF II is the only study of an implantable therapeutic device to show clinical benefit in this population. Within the large responder group, representing 50% of study patients, treatment with the Corvia Atrial Shunt resulted in a 45% reduction in HF events and a 55% greater improvement in QoL compared to sham control.

"We are committed to demonstrating the potential benefit of atrial shunt therapy and anticipate RESPONDER-HF will validate the REDUCE LAP-HF II responder group findings, which correspond to two-thirds of people with HFpEF, or 2 million people in the US alone," commented Dr. Leon.  Dr. Shah further added, "The RESPONDER-HF trial will not only continue to advance our scientific understanding of shunting in HFpEF, but also has the potential to change the treatment paradigm, and in doing so, move us one step closer to precision medicine in heart failure."

More than 26 million people worldwide have HF,² and the majority have HFpEF,³ the largest unmet clinical need in cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated left atrial pressure (LAP), the primary contributor of HF symptoms in HFpEF patients. The shunt is placed via catheter between the left and right atria, forming a passage that allows blood to flow from the high pressure left atrium to the lower pressure right atrium, with the aim of reducing HF symptoms and events and improving QoL.

Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. Visit https://corviamedical.com/.

For information regarding RESPONDER-HF study eligibility, please visit https://treatmyheartfailure.com.

MEDIA CONTACT:

Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com
https://corviamedical.com/newsroom/

1. Borlaug BA et al. Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure. Circulation. 2022;10.1161.
2. Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017;3(1):7-11.
3. Owan TE et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251-259

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