A commercial-stage company, Nuwellis, Inc. (NASDAQ:NUWE) dropped over 23.28% to $1.13 after it reported the publication of key clinical data supporting the use of ultrafiltration with the Aquadex FlexFlow System in high-risk postoperative coronary artery bypass grafting (CABG) patients in the Journal of Cardiac Surgery.
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 Division of Cardiothoracic Surgery at Baylor Scott & White Health in Temple, Texas between January 1, 2020 and July 31, 2021. A total of 254 CABG procedures were performed during this period, and ultrafiltration was used in 17 (6.7%) patients. Despite an elevated mean Society of Thoracic Surgeons mortality score of 5.7% (range 0.6-50.0), the 30-day survival rate of patients treated with ultrafiltration was 100%.
The Surgical Director of Heart Transplantation and Mechanical Circulatory Support at Baylor Scott & White Health and the study’s lead author, Daniel Beckles stated that ultrafiltration technology has been used for decades to effectively 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. He added, “These favorable results are consistent with the clinical findings in other large academic centers using ultrafiltration technology in cardiac surgery, and we are eager to gather additional multi-institutional data about the use of Aquadex for this challenging patient population.”
“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 Nestor Jaramillo, Jr., President and CEO of Nuwellis. “The Aquadex System offers a significant opportunity to the medical community to improve clinical outcomes. In 2019, we made the decision to expand our strategic focus to include the use of Aquadex in critical care (cardiac surgery) and pediatric settings. Today, critical care represents approximately 40% of our total revenue, confirming the execution of the strategy and the clinical value of the Aquadex System in this patient segment.”
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