MINNEAPOLIS, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the peer-reviewed publication of the results from a 10-year, real-world retrospective analysis of 334 hospitalized acute decompensated heart failure patients with fluid overload treated with adjustable ultrafiltration (UF) using the Aquadex FlexFlow System®. Published in the American Heart Journal Plus, the analysis conducted by investigators at Abington Hospital-Jefferson Health in Abington, Pennsylvania demonstrated significant reductions in heart failure hospitalizations and 30-day hospital readmission rates, as well as improvements in renal function response, using Aquadex ultrafiltration.
The published study, titled “Ten-Year Real-World Experience with Ultrafiltration for the Management of Acute Decompensated Heart Failure,” findings included:
- Patients experienced an overall 81% decrease in heart failure hospitalizations per year;
- Rehospitalizations for patients after receiving UF with Aquadex were 48% less than the national average at 30 days (12.4% vs. 24%);
- 55% of patients achieved sustained weight loss greater than 15 lbs.; and
- All patients had stable renal function at follow-up.
“We found that ultrafiltration can be used safely and effectively for significant volume removal among patients admitted with decompensated heart failure. Compared to previous trials with ultrafiltration, this real-world experience demonstrates that ultrafiltration compares favorably for weight/volume loss and renal function response, and this may be associated with a lower heart failure rehospitalization rate. We found ultrafiltration to be safe with regard to renal function, despite the cohort in this study being sicker than those studied in other clinical trials,” said Donald Haas, MD, Medical Director, Mechanical Circulatory Support and Director, Comprehensive Heart Failure Program at Abington-Jefferson Health, and Co-Investigator. “Importantly, the rate and duration of ultrafiltration was slower and longer in our study, and we believe that these considerations, combined with adjustments to the UF rate as necessary, are crucial to safely engendering large-volume decongestion.”
“These results are consistent with the AVOID-HF Win Ratio analysis recently presented at the Heart Failure Society of America (HFSA) 2022 Annual Scientific Meeting that demonstrated statistically significant clinical superiority of ultrafiltration therapy using the Aquadex System over diuretics in reducing heart failure events within 30 and 90 days,” said Nestor Jaramillo, Jr., President and CEO of Nuwellis. “We are grateful to both Dr. Haas and Dr. Robert Watson, Principal Investigator and Chief of Cardiology and Co-Director, and to the study’s Sub-Investigators, Maureen Hummel, CRNP, and Patricia Barrella, RN, MSN, for studying their center’s experience with Aquadex FlexFlow. We look forward to helping other healthcare providers learn from their findings. Nuwellis is committed to making Aquadex therapy the standard of care for fluid management in heart failure patients that are unresponsive to diuretics.”
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from 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.
About the Aquadex SmartFlow®
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and predictable 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. The Aquadex FlexFlow, which was the specific Aquadex model used in the study above, is an earlier version of the Aquadex SmartFlow. The SmartFlow was commercially released by the Company on February 26, 2020.
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 2022 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 impact of the COVID-19 pandemic, 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.
CONTACTS
INVESTORS:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
