Nuwellis (NUWE) Announces New Real-World Data Highlight the Clinical Benefits of Ultrafiltration Therapy with Hematocrit Monitoring for Pediatric Patients

November 28, 2023 8:09 AM EST

New real-world data demonstrate that pediatric patients with fluid overload respond well to Aquadex® ultrafiltration therapy with continuous hematocrit monitoring, announced Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload. The publication, “Using Aquapheresis with Continuous Hematocrit Monitoring to Guide Ultrafiltration,” was featured in Pediatric Nephrology. 1

The publication is a single-center case study review of pediatric patients with hypoalbuminemia and severe fluid overload. Patients were treated with Nuwellis’ Aquadex® ultrafiltration therapy with continuous hematocrit monitoring to guide isotonic fluid removal. The study concluded that the therapy successfully treated small patients without hemodynamic instability or other complications, demonstrating that Aquadex is an effective treatment option for fluid overload.

“We’re proud to share new evidence supporting the clinical need and applications for Aquadex among pediatric patients, and we’re grateful to Dr. Michelle Starr and her colleagues for their trust and confidence in our therapy,” said Nestor Jaramillo, Jr., President and Chief Executive Officer of Nuwellis. “Our proprietary hematocrit sensor which is incorporated into the Aquadex console was a result of physician feedback and observations from clinical studies that drove us to make our Aquadex therapy even smarter. Our team is committed to supporting diuretic-resistant patients broadly, and I’m encouraged to see data validating this strategy as Nuwellis works to expand access to ultrafiltration to even more patients and clinicians.”

“Managing fluid overload for pediatric patients can be challenging, but these new data and our growing library of evidence support our view that Aquadex can provide a safe and effective method for restoring fluid balance,” said John Jefferies, MD, Chief Medical Officer of Nuwellis. “The continuous hematocrit monitoring function within the Aquadex provides unique and proprietary therapeutic direction, as demonstrated in this important publication.”

Effectively managing fluid overload for pediatric patients is critical. Fluid overload is associated with significant increases in mortality in pediatric patients. Research has shown that a 3% increase in mortality is observed for every 1% increase in fluid overload among these patients. 2,3

Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional 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. The device’s built-in, customizable hematocrit monitoring technology provides real-time measurement of percent blood volume changes that can be tailored to individual patients’ needs. A customizable fluid removal rate is particularly important for pediatric patients, who have a small amount of blood in their bodies. The Aquadex system is cleared by the FDA for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more.

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