Nuwellis Announces New Clinical Data Demonstrating 100% Survival at 30 Days Following Use of Ultrafiltration in High-Risk Postoperative Coronary Artery Bypass Grafting (CABG) Patients
The study, “The Use of Simple Ultrafiltration Technology as a Fluid Management Strategy for High-Risk Coronary Artery Bypass Grafting Surgery,” is a real-world retrospective review of postoperative isolated CABG patients who were treated in the
“Ultrafiltration technology has been used for decades to successfully treat advanced heart failure patients and data hav been published to demonstrate its outcomes, but its application in cardiac surgery to treat fluid overload is innovative,” said
According to the
“We are pleased with the results of this first-of-its-kind study highlighting the benefits of Aquadex therapy for high-risk CABG patients,” said
In addition to cardiovascular surgery, Nuwellis continues to make significant progress in other key areas of patient need, including heart failure and pediatrics. The company recently announced the first patient enrolled in its REVERSE-HF clinical study, which is evaluating the clinical outcomes and economic value of its Aquadex® ultrafiltration therapy in comparison to intravenous (IV) diuretics for the treatment of fluid overload in patients with worsening heart failure. Nuwellis is also developing a new, fully integrated pediatric continuous renal replacement therapy (CRRT) device designed to provide care for small babies and children. This device is being funded in part by a
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.
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
1 Bowdish ME, D’Agostino RS, Thourani VH, Schwann TA, Krohn C, Desai N, Shahian DM, Fernandez FG, Badhwar V. STS Adult Cardiac Surgery Database: 2021 Update on Outcomes, Quality, and Research. Ann Thorac Surg 2021;111:1770-80.
2 Pal S. Primary Causes of End-Stage Renal Disease. US Pharm. 2016;41(8):6.
George Montague, CFA Chief Financial Officer, Nuwellis, Inc.firstname.lastname@example.org Leigh Salvo Gilmartin Group LLCleigh@gilmartinir.com MEDIA: Sarah LundbergHealth+Commerce email@example.com
Source: Nuwellis, Inc.