ICU News & Events

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 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.