LANDMARK REDUCE LAP-HF II TRIAL DEMONSTRATES CLINICAL BENEFIT OF CORVIA® ATRIAL SHUNT IN LARGE SEGMENT OF HEART FAILURE PATIENTS

REDUCE LAP-HF II study defines treatable HFpEF patient population for atrial shunt therapy

TEWKSBURY, Mass., Feb. 2, 2022 /PRNewswire/ -- Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure (HF), today announced results from its REDUCE LAP-HF II randomized clinical trial, investigating the safety and efficacy of the Corvia® Atrial Shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. While the overall outcome of the trial was neutral, the data suggests patients with normal exercise pulmonary vascular resistance (PVR) and without a pacemaker, represent a responder group that derives significant clinical benefit, making atrial shunting the first implantable therapy to demonstrate effectiveness in HFpEF. Results were presented today at the Technology and Heart Failure Therapeutics (THT) 2022 conference and primary results were published online in The Lancet. Publication of the responder group analysis is pending.

"In this first-of-its-kind device trial for a complex and heterogenous type of heart failure, we have identified a large potential responder population with meaningful clinical benefit. The ability to predict responders and non-responders is ground-breaking and has significantly advanced our understanding of the role of atrial shunting in HFpEF," said Sanjiv Shah, MD, Professor of Medicine, Director of Research for the Bluhm Cardiovascular Institute, and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine and co-principal investigator of the REDUCE LAP-HF II trial.

The REDUCE LAP-HF II trial is the world's first phase III trial to evaluate an atrial shunt in heart failure patients to reduce HF symptoms, decrease HF-related hospitalizations and improve quality of life through a reduction in left atrial pressure (LAP).  A total of 626 patients were randomized at 89 centers across the US, Canada, Europe, Australia, and Japan. Patients with normal exercise PVR, indicating the absence of pulmonary vascular disease (PVD), and without a pacemaker, derived significant clinical benefit, including a reduction in heart failure events compared to sham (0.12 vs. 0.22 events per patient-year, p=0.007) and a significant and clinically meaningful difference in health status improvement over sham (+5.5 points) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.¹

"Prior to this study, we knew patients with significant PVD would be very unlikely to benefit from atrial shunt treatment. However, we didn't fully appreciate the critical role that invasive exercise phenotyping may have in uncovering the degree of PVD that allows patients to benefit from atrial shunting," added Barry Borlaug, MD, Professor of Medicine and Director of Circulatory Failure Research at Mayo Clinic. "While further study is needed, with appropriate patient selection, atrial shunting may be a great option for HFpEF patients without any form of PVD. In REDUCE LAP-HF II, treated patients with normal pulmonary vasculature confirmed through exercise, had a significantly greater likelihood of clinical benefit than sham control, with a lower HF event rate and a significant and clinically meaningful KCCQ improvement."

More than 26 million people in the world have heart failure,² and over half of those have HFpEF,³ which has been described as the largest unmet clinical need in cardiovascular medicine. "These data have important implications not only for the Corvia Atrial Shunt, but for ongoing and future trials utilizing atrial shunt devices and procedures to treat heart failure," stated Martin Leon, MD, Professor of Medicine and Director of Interventional Cardiovascular Care at Columbia University Irving Medical Center and co-principal investigator of the REDUCE LAP-HF II trial.

"We are proud that REDUCE LAP-HF II has led us to a major clinical breakthrough in HFpEF and we are working closely with our clinical advisors and regulators to expand access to this novel therapy," said Jan Komtebedde, Senior Vice President and Chief Medical Officer of Corvia Medical. Added George Fazio, CEO of Corvia Medical, "For the past 12 years, Corvia Medical has been dedicated to bringing atrial shunting to the millions of heart failure patients who might benefit, and we are now one giant step closer to making our mission a reality."

About Heart Failure
Heart failure (HF) is a chronic condition that affects approximately 26 million people worldwide. By 2030, that number will increase by almost 50%, to nearly 38 million people. More than half of all HF patients have HFpEF/HFmrEF, and that number is increasing, driven by population aging and other risk factors. In these patients, the proportion of blood pumped out of the heart is normal or relatively normal, but because the muscles of the left atrium and ventricle are stiff, the heart cannot relax and fill properly, causing an increase in pressures in the left heart chambers and the lungs. HFpEF/HFmrEF remains one of the most significant unmet needs in cardiovascular medicine. While there have been significant advances in treatment for heart failure with reduced ejection fraction (HFrEF), there are limited treatment options for HFpEF/HFmrEF.

About the Corvia Atrial Shunt (IASD®)
The Corvia Atrial Shunt is a novel, transcatheter implant for patients suffering from symptomatic heart failure (HF) and the first therapeutic device designed to directly address elevated left atrial pressure (LAP), the primary contributor of HF symptoms. The device (about the size of a dime) is implanted by an interventional cardiologist or electrophysiologist during a minimally invasive, outpatient procedure. After a small opening is created in the atrial septum, the Corvia Atrial Shunt is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering LAP and pressure in the lungs. By facilitating continuous and dynamic decompression of the left atrium, the Corvia Atrial Shunt aims to improve HF symptoms and quality of life, decrease HF hospitalizations, and reduce the overall cost of managing HF patients. The Corvia Atrial Shunt is the most clinically studied atrial shunt for the reduction of LAP in symptomatic HF patients. It was granted Breakthrough Device designation by the FDA in 2019. The Corvia Atrial Shunt is an investigational device and is not available for commercial distribution in the United States. The device is available for sale in the European Union.

About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia Medical is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. For more information, visit https://corviamedical.com/.

MEDIA CONTACT:
Lisa Ensz
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1. REDUCE LAP-HF II 12-Month Primary Endpoint Report Addendum, Baim Institute 2022-01-18.
2. Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017;3(1):7-11.
3. Owan TE, Hodge DO, Herges RM, 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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