Nuwellis announces the activation of new sites for its

MINNEAPOLIS, Sept. 27, 2022 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a commercial enterprise focused on transforming the lives of those suffering from water overload, today announced the activation of three sites for its pivotal REVERSE-HF clinical study (ultrafiltration versus IV diuretics in worsening heart failure). Jefferson Abington Hospital in Pennsylvania, University of California San Francisco (UCSF) and Baycare Morton Plant Hospital in Florida are now eligible to enroll patients and evaluate clinical outcomes and economic value of ultrafiltration therapy Aquadex® versus intravenous (IV) diuretics for the treatment of fluid overload in patients who do not respond to diuretics and whose heart failure is worsening.

“We have significant experience providing ultrafiltration therapy to patients with acute decompensated heart failure and our recent 10-year retrospective study showed that it compares favorably in reducing heart failure rehospitalizations, the response of kidney function and loss of weight and fluid volume1said Dr. Donald Haas, MD, Medical Director, Mechanical Circulatory Support and Director, Comprehensive Heart Failure Program at Jefferson Abington Hospital. “The REVERSE-HF study has the potential to provide the highest level of evidence while demonstrating the clinical, economic and quality of life benefits of using ultrafiltration to treat patients with heart failure who do not respond to diuretics.”

Heart failure can disrupt normal kidney function and reduce its ability to remove sodium from the body, leading to excessive fluid retention that can lead to fluid overload. More than one million hospitalizations for heart failure occur each year in the United States, and fluid overload is the predominant cause in 90% of patients. Additionally, a quarter of patients with heart failure will be readmitted to hospital within 30 days of their initial discharge, and half will be readmitted within 6 months.2 Clinical studies have shown that ultrafiltration can reduce these readmissions by half.

“Fluid overload is a major contributor to morbidity and mortality in patients with heart failure. Additionally, the frequent hospital readmissions to treat these patients place a huge burden on our healthcare system,” said Dr. Liviu Klein, MD, Professor of Clinical Medicine and Director of Clinical Research in Cardiology at the University. from California to San Francisco. “Ultrafiltration has the potential to more adequately decongest patients with heart failure who are unresponsive to diuretics, thereby reducing readmissions, improving clinical and economic outcomes and patient quality of life. We look forward to participating in the REVERSE-HF study.

REVERSE-HF is a multicenter, open-label, randomized controlled trial conducted across the United States. The study is led by Sean Pinney, MD, professor of medicine and co-director of the Heart and Vascular Center at the University of Chicago Medicine, and Maria V. DeVita, MD, professor of medicine at the Hofstra School of Medicine/Northwell and chief of the division of nephrology at Lenox Hill Hospital.

“The current standard of care for treating patients with heart failure with fluid overload has led to mixed results because a significant number of them do not respond to traditional diuretics,” said Dr. Leslie Miller, director of heart failure at BayCare Morton Plant. “Early application of ultrafiltration therapy in appropriate patients could improve their outcomes and quality of life by decongesting them more adequately, thereby reducing the risk of rehospitalizations. We are excited to further evaluate the benefits of ultrafiltration with Aquadex in the treatment of these patients.

“We are excited about the activation of Jefferson Abington Hospital, University of California San Francisco, and BayCare Morton Plant as REVERSE-HF study sites,” said Nestor Jaramillo, Jr. , President and CEO of Nuwellis. “All three institutions have a long history of clinical excellence and experience that will contribute to its successful listing. We are grateful to Drs. Haas, Klein, Miller and their clinical teams for their contributions to gathering additional evidence supporting the benefits of ultrafiltration therapy in patients with heart failure.

The primary efficacy endpoint of REVERSE-HF will assess mortality and heart failure events at 30 days and 90 days as a comparison between Aquadex therapy and IV loop diuretics. The study will assess safety parameters including, but not limited to, cardiovascular and renal adverse events of particular interest.

REVERSE-HF uses a statistical method that increases accuracy by demonstrating significant differences in clinical outcomes between treatment arms. This statistical method, called the Finkelstein-Schoenfeld method of Win-Ratios, has also recently been used to re-evaluate the data obtained during the randomized controlled trial AVOID–HF (Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure), which was the first to propose that patients be treated with adjustable ultrafiltration compared to those receiving adjustable loop diuretics. The AVOID-HF trial tested the hypothesis that patients hospitalized for heart failure and treated with ultrafiltration would have a longer time to their first heart failure event within 90 days of discharge from hospital compared to those receiving IV loop diuretics. AVOID-HF had a favorable trend when discontinued before reaching full listing for reasons unrelated to patient safety or clinical futility. The Win-Ratio analysis of AVOID-HF will be presented as a late-breaking abstract at the Heart Failure Society of America’s Annual Scientific Meeting in Washington DC on September 30. This article should also be published later in a peer-reviewed journal. This year.

In addition to Jefferson Abington, USCF, and BayCare Morton Plant, Nuwellis is currently working in partnership with other clinical institutions that will soon be recruiting patients for the REVERSE-HF study. The Company anticipates that at least 12 clinical sites will participate in the study.

About Nuwellis

Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients with fluid overload through science, collaboration and innovation. The Company is focused on developing, manufacturing and marketing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, Minnesota with a wholly owned subsidiary in Ireland.

About the Aquadex SmartFlow System

The Aquadex SmartFlow System provides clinically proven therapy using a simple, flexible and predictable method to remove excess fluid in patients with hypervolemia (fluid overload). The Aquadex SmartFlow System is indicated for temporary (up to 8 hours) or prolonged (greater than 8 hours in patients requiring hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload does not respond to medical management, including diuretics. All treatments should be administered by a healthcare provider, in an outpatient or inpatient clinical setting, under medical prescription, both of whom have received training in extracorporeal therapies.

Forward-looking statements

Certain statements in this release may be deemed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding new market opportunities and expected growth in 2022 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, therefore, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements contained in this release, including, without limitation, risks associated with our ability to execute our go-to-market strategy, the impact of the pandemic of COVID-19, the possibility that we may be unable to raise sufficient funds necessary for our planned operations, our post-marketing clinical data collection activities, the benefits of our products to patients, our expectations for the development of products and marketing efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, protection of intellectual property, our ability to integrate acquired businesses, our expectations regarding anticipated synergies and benefits of acquired businesses, and other risks and t uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date they are made. Nuwellis undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

1. Watson R, et al. Card failure J. 2020; 26(10): S56.

2. Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19)2428-2445