Application follows successful pilot study demonstrating the SCD was safe with probable clinical benefits for pediatric patients
DENVER, CO and TAMPA, FL, July 20, 2022 — 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).
About the Selective Cytopheretic Device (SCD)
The Selective Cytopheretic Device (SCD) is a medical device that employs immunomodulating technology to selectively target pro-inflammatory neutrophils and monocytes during CRRT and remove the cytokine storm that causes inflammation, organ failure, and possible death in critically ill patients. The device works with hemofiltration systems to enable precise fluid and solute balance control to selectively target and transition pro-inflammatory monocytes to reparative and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may reverse injury and eliminate the need for CRRT going forward.
About SeaStar Medical, Inc.
Denver-based SeaStar Medical is a privately-held medical technology company that is focusing on redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically-ill patients. It is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit http://www.seastarmedical.com/ or visit us on LinkedIn or Twitter.
About LMF Acquisition Opportunities, Inc.
LMF Acquisition Opportunities, Inc. (Nasdaq: LMAO) is a special purpose acquisition company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. LMAO is led by Bruce M. Rodgers, Chief Executive Officer and Chairman of the Board. For more information, visit www.lmfacquisitions.com.