Business
SeaStar Medical Granted FDA Breakthrough Device Designation for a Novel Immunomodulatory Therapy for Acute Kidney Injury Patients
Designation helps enable accelerated regulatory review of upcoming pivotal clinical trial for treatment in adult patients with acute kidney injury DENVER, CO
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"Designation helps enable accelerated regulatory review of upcoming pivotal clinical trial for treatment in adult patients with acute kidney injury\nDENVER, CO and TAMPA, FL, May 03, 2022 (GLOBE NEWSWIRE) -- 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 that SeaStar Medical’s Selective Cytopheretic Device (SCD) has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The SCD is a patented, cell-directed, extracorporeal immunomodulator that selectively targets activated neutrophils and monocytes to address hyperinflammation. Neutrophils and monocytes are the cellular mediators that drive systemic inflammation, which when spreading uncontrollably through the body can lead to organ damage, organ failure or death. The SCD technology targets the cellular drivers of inflammation to restore immune balance in the body and potentially reverse the damage. The Breakthrough Device Designation recognizes our platform's potential to address one of the biggest unmet clinical needs in managing acute kidney injury,\" said Eric Schlorff, President and Chief Executive Officer of SeaStar Medical. \"The clinical data generated to date in both adults and pediatrics, has shown a reduction of mortality and dialysis dependency in this critically-ill patient population. We look forward to working with the FDA to deliver a novel therapy that addresses activated neutrophils and monocytes.\" The Breakthrough Device Designation is expected to enable expedited regulatory review to advance SeaStar Medical’s upcoming pivotal clinical trial for treatment of acute kidney injury (AKI) in adults. According to The Economic Consequences of Acute Kidney Injury by Nephron in 2017, AKI is associated with an increase in hospitalization costs that are estimated between $5.4 and $24.0 billion annually in the United States. As a result, SeaStar Medical estimates a multi billion dollar initial target market in the US for the SCD, with potential for expansion into acute respiratory distress syndrome (ARDS), extracorporeal membrane oxygenation (ECMO) and other indications. “This breakthrough designation should help accelerat...