SeaStar Medical Holding Corp (ICU) News & EventsICUSeaStar Medical Holding Corp

SeaStar Medical Receives ICD-10 Codes for SCD Therapy

SeaStar Medical announced that its Selective Cytopheretic Device, or SCD, therapy has received dedicated ICD-10-PCS codes from the Centers for Medicare & Medicaid Services, or CMS. This assignment enables administrative, billing, and statistical reporting for the use of SeaStar Medical's SCD therapy in patients with acute kidney injury requiring renal replacement therapy (RRT) in the inpatient hospital setting. "We are thrilled that we were able to obtain universal billing codes for our SCD therapy. This will ease the logistics for our existing QUELIMMUNE customers, but importantly, has significant implications for the potential launch of our SCD therapy in the adult AKI indication. We estimate this market is about 50 times larger than the pediatric market, or approximately $4.5 billion. Having reimbursement codes in place will be a substantial benefit for rapid adoption of a product in this market," stated Tim Varacek, senior VP of commercial and business operations of SeaStar Medical.

SeaStar Medical Completes Patient Enrollment in SAVE Registry

SeaStar Medical announced that it has completed the required enrollment in the SAVE Registry, a Post-Approval Study, PAS, required by the FDA that is designed to confirm the safety of the Quelimmune therapy as a treatment for children with acute kidney injury due to sepsis or a septic condition requiring renal replacement therapy. The registry has successfully enrolled 50 patients, and the company will be reporting the 28-day safety results from the SAVE Registry to the FDA upon completion of its analysis of the data.

SeaStar Medical Publishes QUELIMMUNE Clinical Data

SeaStar Medical Holding Corporation announced the publication of early post-approval clinical experience from the use of the QUELIMMUNE therapy in the prestigious, peer-reviewed journal Pediatric Nephrology.The publication, co-authored by leading experts including Stuart Goldstein, Kelli Krallman, Meredith Harris, Rajit Basu, David Askenazi, Shina Menon, Matt Zinter, Steven Gorga, and H. David Humes, highlights early experience from the SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine. Additional analyses included survival of patients requiring extracorporeal membrane oxygenation and independence from renal replacement therapy for pediatric patients without a history of end-stage renal disease or a recent kidney transplant. The evaluation of five patients concomitantly treated with the QUELIMMUNE therapy and ECMO showed a 60% survival rate at Day 90. Among pediatric patient survivors without a history of end-stage renal disease or a recent kidney transplant, 75% (9 of 12) and 83% (10 of 12) were dialysis free at Day 28 and Day 90, respectively.