News Release

Aquadex SmartFlow® System by Nuwellis Selected as a 2021 R&D 100 Awards Winner

November 4, 2021

EDEN PRAIRIE, Minn., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ: NUWE) was honored at the 2021 R&D 100 Awards last month, with its Aquadex SmartFlow® system selected as a winner in the Analytical/Test category. The awards, presented by R&D World, recognize commercial products, technologies and materials for their technological significance that are available for sale or license. This renowned worldwide competition is its 59th year and received entries from 17 countries/regions. This year, the judging panel included nearly 40 well-respected industry professionals from across the globe.

The Aquadex SmartFlow System simply, safely, and precisely removes excess fluid (primarily salt and water) from patients suffering from fluid overload who have not responded to medical management, including diuretics. Providers can specify and adjust the rate of fluid removed for each individual patient, resulting in a gradual reduction of excess fluid. Up to 500 mL per hour of excess fluid can be removed.

The Aquadex system was selected as a recipient of this award specifically for its indication for use. The console received FDA 510(k) clearance in the U.S. for use in adult and pediatric patients who weigh 20kg or more in February 2020. Since receiving this expanded indication, it has been used in more than a dozen leading pediatric hospitals by physicians for the treatment of pediatric patients (≥20 kg) who otherwise have limited treatment options to manage fluid overload. The system provides a gentle and safe solution to treat patients.

“It is an honor to be included among so many terrific companies that have developed technologies that are making positive impacts on people’s lives,” said Nestor Jaramillo, Jr., president and CEO of Nuwellis. “Each month, more children’s hospitals are gaining access to our life-saving technology. We are looking forward to continuing to develop and grow in this therapeutic area to give access to the best possible treatment options for the most delicate patient population.”

Award recipients were announced at a virtual ceremony on Tuesday, October 19, 2021.

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 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 System
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.

Investor Contacts:
George Montague
Chief Financial Officer, Nuwellis,

Matt Bacso, CFA
Gilmartin Group

Media Contact:
Laurel Hood

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Source: Nuwellis, Inc.