SeaStar Medical QUELIMMUNE Therapy Shows Statistically Significant Survival Benefit in Pediatric Sepsis-Associated AKI Registry

SeaStar Medical Holding Corporation (Nasdaq: ICU) announced statistically significant survival findings from the post-approval QUELIMMUNE SAVE Surveillance Registry in critically ill pediatric patients with sepsis-associated acute kidney injury. The results represent a key clinical milestone for the company's Selective Cytopheretic Device technology, which is commercialized as QUELIMMUNE for children aged 22 or younger who have AKI linked to sepsis and are receiving renal replacement therapy in an intensive care unit setting.

The SAVE Registry is a post-approval study mandated by the FDA to confirm the safety and outcomes of QUELIMMUNE therapy. Earlier interim data from the registry, drawn from 21 critically ill pediatric patients, showed no device-related safety events and a 75% survival rate through 28 days, a result the company said was on track to validate or exceed a 50% reduction in loss of life compared to historical benchmarks published in Kidney Medicine. The new full-registry analysis now meets the threshold of statistical significance, strengthening the evidentiary case for the therapy.

In a separate development, Sagimet Biosciences (Nasdaq: SGMT) reported progress on its AURORA Phase 3 trial of denifanstat, an oral FASN inhibitor being studied for moderate to severe acne. All trial sites have been identified, a contract research organization has been retained, and patient screening is expected to begin in October 2026 with first enrollment to follow shortly after in Q4 2026. Positive Phase 3 results from a Chinese licensing partner have raised expectations for the U.S. study, which targets a market estimated at 10 million Americans with moderate to severe acne.

Also this week, the Brazilian Society of Cardiology, with endorsement from the International Contrast Ultrasound Society, published new evidence-based guidelines calling contrast-enhanced ultrasound with microbubble agents safe, cost-effective, and well-supported by scientific evidence for cardiovascular applications.