FDA granted SeaStar Medical a Breakthrough Device designation for its Selective Cytopheretic Device in adults with sepsis or a septic condition. The Denver company, which trades as ICU on Nasdaq, announced it October 7. It is the seventh designation the SCD platform has collected.
The SCD runs inline with a continuous renal replacement circuit and targets activated immune cells, pushing proinflammatory monocytes toward a reparative state. The pediatric version, QUELIMMUNE, has been on the market since 2024 under a Humanitarian Device Exemption, a safety and probable benefit standard rather than a demonstration of effectiveness.
The adult case rests on NEUTRALIZE-AKI, a 339-patient trial in ICU patients on continuous renal replacement, with a primary composite of 90-day mortality or dialysis dependency. A sepsis subgroup is pre-specified, and the company expects that readout in the near term.
Seven designations on one device is a reminder of what Breakthrough buys: earlier and more frequent contact with the review division, not a lower evidence bar. SeaStar still has to win NEUTRALIZE-AKI. Nothing approved today treats the dysregulated immune response in sepsis, which is the opportunity and also the reason the endpoint is hard to hit.