MINNEAPOLIS, April 09, 2024 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE) right this moment introduced that Detroit, Michigan-based well being system, Henry Ford (NYSE:) Well being, has begun providing ultrafiltration remedy to coronary heart failure sufferers affected by fluid overload utilizing the corporate’s Aquadex SmartFlow system as a part of Nuwellis’ pivotal REVERSE-HF medical examine.
We’re excited to review the impression of Aquadex SmartFlow remedy on our coronary heart failure sufferers who’re affected by extreme fluid overload, stated Dr. Jennifer Cowger, Part Head of the center failure program at Henry Ford. We’re desperate to see if ultrafiltration can have an effect on medical outcomes of our coronary heart failure sufferers proof against diuretics. Presently, diuretics are the one choices within the discipline for acute signs reduction of coronary heart failure congestion. This intervention might change that and will have a longer-term useful impression on coronary heart failure too.
The guts failure affected person inhabitants continues to broaden within the U.S. and worldwide, and Nuwellis is devoted to addressing the remedy wants of those sufferers whereas serving to well being programs cut back the general value of care, stated Nestor Jaramillo, Jr., President and Chief Govt Officer of Nuwellis. We’re proud and honored to be working with Henry Ford Well being and look ahead to partnering with Dr. Cowger and the group of coronary heart failure specialists by the REVERSE-HF trial. We at the moment have 130 sufferers enrolled within the randomized multicenter trial and Henry Ford is the one web site in Michigan providing this examine intervention.
The Michigan-based Henry Ford Well being Superior Coronary heart Failure Program is among the nation’s main tutorial coronary heart failure facilities, acknowledged for medical excellence in coronary heart failure, coronary heart transplant, and left ventricular help gadget affected person outcomes, providing sufferers the extra possibility of entry to novel and probably life-saving medical trials in coronary heart failure. The Henry Ford Superior Coronary heart Failure Program is among the largest packages in Michigan and is proud to be a key contributor to advancing coronary heart failure medical analysis and care requirements within the U.S.
About REVERSE-HF Scientific ResearchREVERSE-HF is a potential, multicenter, open label, randomized managed trial that’s being carried out throughout the U.S. to guage medical outcomes of adjustable ultrafiltration together with coronary heart failure occasions, mortality, and high quality of life inside 30 and 90 days, as in comparison with IV Loop Diuretics. The examine is led by Sean Pinney, M.D., Icahn College of Medication at Mount Sinai Morningside, New York, and Maria V. DeVita, M.D., Professor of Medication at Hofstra College of Medication/Northwell and Chief of the Division of Nephrology at Lenox Hill Hospital. Presently, 16 medical facilities are actively enrolling sufferers within the examine and these facilities have doubled the month-to-month charge of enrollment up to now in 2024.
In regards to the Aquadex SmartFlow ® SystemThe Aquadex SmartFlow system delivers clinically confirmed remedy utilizing a easy, versatile and sensible technique of eradicating extra fluid from sufferers affected by hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for momentary (as much as 8 hours) or prolonged (longer than 8 hours in sufferers who require hospitalization) use in grownup and pediatric sufferers weighing 20 kg or extra whose fluid overload is unresponsive to medical administration, together with diuretics. All therapies should be administered by a well being care supplier, inside an outpatient or inpatient medical setting, below doctor prescription, each having acquired coaching in extracorporeal therapies.
About NuwellisNuwellis, Inc. (Nasdaq: NUWE) is a medical expertise firm devoted to remodeling the lives of sufferers affected by fluid overload by science, collaboration, and innovation. The corporate is targeted on commercializing the Aquadex SmartFlow ® system for ultrafiltration remedy. Nuwellis is headquartered in Minneapolis, with a completely owned subsidiary in Eire. For extra info go to www.nuwellis.com or go to us on LinkedIn or X.
Ahead-Wanting StatementsSure statements on this launch could also be thought-about forward-looking statements inside the which means of the Non-public Securities Litigation Reform Act of 1995, together with with out limitation, statements relating to the brand new market alternatives and anticipated development in 2024 and past. Ahead-looking statements are predictions, projections and different statements about future occasions which might be primarily based on present expectations and assumptions and, consequently, are topic to dangers and uncertainties. Many elements may trigger precise future occasions to vary materially from the forward-looking statements on this launch, together with, with out limitation, these dangers related to our potential to execute on our commercialization technique, the impression of the COVID-19 pandemic, the likelihood that we could also be unable to lift ample funds obligatory for our anticipated operations, our post-market medical knowledge assortment actions, advantages of our merchandise to sufferers, our expectations with respect to product improvement and commercialization efforts, our potential to extend market and doctor acceptance of our merchandise, probably aggressive product choices, mental property safety, our potential to combine acquired companies, our expectations relating to anticipated synergies with and advantages from acquired companies, and different dangers and uncertainties described in our filings with the SEC. Ahead-looking statements converse solely as of the date when made. Nuwellis doesn’t assume any obligation to publicly replace or revise any forward-looking statements, whether or not resulting from new info, future occasions or in any other case.
CONTACTS
Buyers:Vivian CervantesGilmartin [email protected]
Supply: Nuwellis, Inc.