Nuwellis to develop pediatric renal replacement therapy device with $1.7 million NIH grant
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Minnesota-based company Nuwellis Inc. announced that it will begin development on a continuous renal replacement therapy device designed specifically for infants and small children with kidney failure.
According to a press release, the device will be partially funded by a $1.7 million grant that was awarded to Koronis Biomedical Technologies Corporation (KBT), a company that has partnered with Nuwellis on the project.
The release further noted that the device will be a customized version of the Aquadex SmartFlow system (Nuwellis, formerly CHF Solutions), a product already cleared by the FDA and utilized in clinical settings across the United States for fluid management. Aquadex is approved for use in adults and pediatric patients who weigh 44 pounds or more.
“Historically, providers who treat children face tremendous challenges as we try to adapt therapies designed for adults to small children,” David Askenazi, MD, MSPH, director of the Pediatric and Infant Center for Acute Nephrology at Children’s of Alabama and University of Alabama at Birmingham, said in the release. “Using Aquadex at Children’s of Alabama has enhanced the way we care for children as the small circuit improves how we treat our young patients. Now, with this grant, Nuwellis has the opportunity to create a machine that is a game-changer by addressing the additional unmet needs that we still face on a day-to-day basis.”
Nestor Jaramillo Jr., the president and CEO of Nuwellis, also commented on the announcement in the release.
“Physicians have expressed a real need for neonatal fluid management therapies designed specifically to support the small body size of children and we’re committed to getting safe innovation to market as fast as possible. We’re immensely grateful to the NIH, KBT, and our pediatric nephrologist medical advisors, such as Dr. Askenazi and Dr. Fathallah, for making the development of our pediatric CRRT device possible,” Jaramillo said.
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