GlobeNewswire Inc | Jan 25, 2022 08:00AM EST

January 25, 2022

EDEN PRAIRIE, Minn., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) today announced that the new and dedicated Category III Current Procedural Terminology (CPT) code, 0692T for Therapeutic Ultrafiltration, is now in effect. Healthcare providers can utilize this code when using Aquadex to deliver ultrafiltration to adult and pediatric patients ( 20kg).

Reimbursement is critical in hospital administration decision-making and can make a difference in whether patients have access to the treatment they need, said Nestor Jaramillo, Jr., President and CEO of Nuwellis. Ultrafiltration provides a life-saving therapy and significantly improves quality of life and economic savings. The Category III CPT code will expand access for patients experiencing the burden of fluid overload.

The specific code for ultrafiltration was granted by the American Medical Association (AMA) in July 2021 after a thorough review and validation that the Aquadex technology met the criteria for a Category III CPT code. CPT codes are created and maintained by the AMA CPT Editorial Panel and are widely used by third party payers including Medicare, Medicaid, and commercial health plans. The approved Therapeutic Ultrafiltration Category III CPT code will be in effect for at least five years, or until a Category I code is established.

About NuwellisNuwellis, 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 developing, manufacturing, and commercializing the Aquadex SmartFlow system for ultrafiltration therapy. Nuwellis is headquartered in Eden Prairie, Minn., with a wholly owned subsidiary in Ireland.

About the Aquadex SmartFlow SystemThe 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.

Forward-Looking StatementsCertain 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 2021 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 as a result of new information, future events or otherwise.

CONTACTS

INVESTORS:Matt Basco, CFAGilmartin Group LLCMatt.basco@gilmartinir.com

MEDIA:Sarah LundbergHealth+Commercesarahlundberg@healthandcommerce.com