Nuwellis Announces IRB Approval to Begin Its REVERSE-HF Clinical Study

The REVERSE-HF study will evaluate ultrafiltration therapy for heart failure patients suffering from fluid overload

MINNEAPOLIS, March 15, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) today announced it has received independent Institutional Review Board (IRB) approval for the trial protocol of the company’s REVERSE-HF (Ultrafiltration Versus IV Diuretics in Worsening Heart Failure) clinical study to evaluate the clinical outcomes and economic value of its Aquadex ultrafiltration therapy in comparison to intravenous diuretics for the treatment of fluid overload in patients with worsening heart failure.

“There are more than 1 million heart failure hospitalizations every year in the U.S., and more than 90 percent of these are due to symptoms associated with fluid overload.¹ Forty percent of these patients are refractory to diuretics, which is the current standard of care,” said Nestor Jaramillo, Jr., President and CEO of Nuwellis. “We’re eager to gather more clinical evidence about the life-changing benefits of Aquadex for heart failure patients who don’t respond well to IV diuretics, which REVERSE-HF is intended to establish.”

REVERSE-HF is a multicenter, open-label, randomized controlled trial that will be conducted across the United States. The study will be led by Sean Pinney, M.D., Professor of Medicine and Co-Director of the Heart and Vascular Center at The University of Chicago Medicine, and Maria V. DeVita, M.D., Professor of Medicine at Hofstra School of Medicine/Northwell and Chief of the Division of Nephrology at Lenox Hill Hospital. Enrollment in the trial will begin this year.

“IRB approval of the study protocol marks a key step forward in beginning the REVERSE-HF study,” said Megan Cease, Director of Clinical Research and Reimbursement of Nuwellis. “In addition to Drs. Pinney and DeVita, we have top key opinion leaders on the Steering Committee, and they have had a significant impact in the development of the study protocol and treatment guide. They have been wonderful to work with throughout the study design process.”

An IRB is a group that operates under FDA regulations and has been formally designated to review and monitor biomedical research involving human subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.²