NUWE Newellis Inc

Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company focused on transforming the lives of people with fluid overload, today highlighted promising findings from an updated analysis of the AVOID-HF study, recently published in the Journal of the American College of Cardiology: Heart Failure. The analysis, led by Dr. Sean P. Pinney, Chief of Cardiology at Mount Sinai Morningside and Chief of Nephrology at Lenox Hill Hospital, Dr. Maria V. DeVita, provides new insights suggesting the potential benefits of Aquadex® SmartFlow ultrafiltration therapy in managing heart failure. The analysis found that patients treated with Aquadex therapy demonstrated a 60% reduction in heart failure events at 30 days compared to those receiving traditional IV diuretics.

The AVOID-HF study, initially designed to evaluate the effectiveness of ultrafiltration in managing heart failure, was updated to include a broader dataset, allowing a more comprehensive analysis of patient outcomes. The results indicate a promising trend in the reduction of heart failure events and suggest potential improvements in patient management strategies.

Dr. Sean P. Pinney commented on the findings, "The re-evaluated data from the AVOID-HF study offer compelling evidence supporting the use of ultrafiltration over conventional diuretics. These findings underscore the need for further investigation to fully validate the benefits of this therapy, particularly in reducing hospitalization rates and improving overall quality of life for heart failure patients."

Megan Cotts, the Vice President of Clinical Research and Reimbursement at Nuwellis, stated, "The updated AVOID-HF results contribute valuable insights into the Aquadex SmartFlow system's role in heart failure therapy. We are deeply grateful to Dr. Sean Pinney and Dr. Maria DeVita for their expertise and leadership in this comprehensive review. Our commitment to advancing patient care through innovative solutions is reinforced by these findings, which we believe will inspire further clinical exploration."

The reanalysis demonstrated not only a significant reduction in heart failure events but also suggested trends towards fewer hospitalizations and improved quality of life for those treated with Aquadex therapy over traditional methods. These findings advocate for its continued use in modern heart failure treatment regimens and set the stage for more rigorous trials. Nuwellis plans to continue its research efforts under its current REVERSE-HF trial, led by Dr. Pinney and Dr DeVita, to further establish the clinical and economic benefits of ultrafiltration therapy compared to conventional IV diuretic treatments. The company remains committed to improving outcomes for heart failure patients and reducing the overall burden of hospitalizations. The complete analysis will be available in the February 2025 issue of JACC: Heart Failure.

About the AVOID-HF Trial The AVOID-HF trial, a prospective, multicenter, randomized controlled study, explored whether treating heart failure patients with ultrafiltration could extend the period without heart failure events post-discharge compared to those receiving IV loop diuretics. Utilizing advanced statistical techniques, reanalysis of the AVOID-HF data demonstrated marked clinical advantages, supporting broader clinical adoption of the Aquadex system.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company focused on transforming the lives of patients with fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X.

About the Aquadex SmartFlow® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

For further information, please contact:

Investor Relations: Vivian Cervantes Gilmartin Groupir@nuwellis.com

Media Contact: Leah McMullenDirector of CommunicationsLeah.mcmullen@nuwellis.com

Source:Nuwellis Inc.