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SeaStar Medical, a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ:LMAO) (LMAO), a special purpose acquisition company, today announced SeaStar Medical has submitted its application to the U.S. Food and Drug Administration ("FDA") for Humanitarian Device Exemption (HDE) for use of the Selective Cytopheretic Device (SCD) for critically-ill children with acute kidney injury (AKI). The FDA informed SeaStar Medical that it has accepted the application and will begin its review.
The SCD is an extracorporeal device designed to be used as an adjunct therapy with continuous renal replacement therapy (CRRT) to improve the outcomes of pediatric patients with AKI. The HDE application submission to the FDA is based on findings from SeaStar Medical's Pilot Study (NCT02820350) of pediatric patients with AKI. This study demonstrated that the SCD was safe for use in pediatric patients.
"There are very few therapeutic options available for pediatric AKIs," said Stuart Goldstein, MD from Cincinnati Children's Hospital and principal investigator of the SeaStar Medical's Pilot Study. "The clinical results showed the safety and probable clinical benefit to these critically-ill patients." Dr. Goldstein also served as a consultant to SeaStar Medical in the preparation and submission of the HDE application.
"The FDA's acceptance of the HDE application represents an important step forward in helping pediatric specialists care for these critically-ill children," said Eric Schlorff, Chief Executive Officer of SeaStar Medical. "We believe use of the SCD holds tremendous promise for these patients and look forward to working closely with the FDA in the review of our application."
Roughly 4,000 pediatric patients in the U.S. each year with AKI require CRRT and those patient profiles are associated with high morbidity and mortality. The mortality rate in children with AKI requiring CRRT is approximately 50 percent. Children who survive an AKI episode are at risk of long-term conditions, including chronic kidney disease (CKD).
