SeaStar Medical and Nuwellis Report Receiving FDA Humanitarian Device Exemption

DENVER, Colo., Feb 22, 2024 ( SeaStar Medical Holding Corporation (NASDAQ:ICU), which is the distribution partner of Nuwellis Inc (NASDAQ:NUWE), reported, this morning, that it received the FDA’s Humanitarian Device Exemption (HDE) for Quelimmune, its pediatric Selective Cytopheretic Device.

SeaStar Medical Holding Corporation (NASDAQ:ICU) is trading at $1.53, up $0.08 (+5.52%), on trading volume of 11.7M shares. Its 52-week range is $0.162 to $3.29 and has a gap from around $1.50 to $2

Nuwellis (NASDAQ:NUWE) is trading at $0.631, up $0.016 (+2.60%), on trading volume of 1.6M shares. Its 52-week range is $0.3865 to $8.48

“Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. With FDA HDE in place for Quelimmune, Nuwellis will begin commercial launch activities at targeted medical centers, with further commercial expansion expected later in the first half of 2024.”

“Approximately 4,000 pediatric patients are hospitalized with AKI each year in the U.S.1 and these children are at grave risk when their bodies enter an uncontrolled inflammatory response called a cytokine storm. The unique technology behind Quelimmune has demonstrated a 50% mortality rate reduction in children with potentially deadly hyperinflammation,2” said Nestor Jaramillo, Jr., president and chief executive officer of Nuwellis. “The pediatric segment of our business has gained significant traction since the 2020 FDA clearance of our Aquadex device for pediatric patients weighing 20kg or more – growing at a compound annual growth rate (CAGR) of over 30%. The addition of Quelimmune to our current product offering will help save the lives of many pediatric patients and should have a meaningful impact on our revenue trajectory.”

“We’re proud to receive HDE for Quelimmune, designed to address the limitations of today’s therapeutic options for critically ill pediatric patients with cytokine storm-induced hyperinflammation,” said Eric Schlorff, chief executive officer of SeaStar Medical. “Through Nuwellis’ established relationships within pediatric nephrology and critical care, we look forward to bringing Quelimmune to market quickly to the patients who need it most.”

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