The Aquadex system simply, safely, and predictably removes excess fluid (primarily salt and water) from patients suffering from fluid overload who have not responded to medical management, including diuretics. Nuwellis is focused on bringing this innovative treatment to three primary areas: heart failure, critical care, and pediatrics.

“Heart failure and critical care make up a large market opportunity for Nuwellis in the adult patient population,” said Epshteyn. “Pediatrics is a smaller overall market, and one that larger companies don’t necessarily want to pursue. We want to help our most vulnerable patients and play a leading role in that market. We are actively innovating to address current and future needs of the pediatric patients.”

Critically-ill children and infants with kidney failure – or who are dependent on artificial kidney support – currently do not have enough therapeutic options. In 2020, Nuwellis took a step towards better supporting this population with FDA approval of the Aquadex system to treat pediatric patients weighing 20 kg (44 lbs) or more. And while an important step, it was not enough for the very smallest patients.

In August 2021, Nuwellis announced plans to address this unmet need head-on, with the development of a fully integrated pediatric continuous renal replacement therapy (CRRT) device designed to provide care for some of the smallest babies and children. The new device will build on Nuwellis’s expertise in fluid balance therapies and improve access to lifesaving care.