SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.
The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.
The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.
SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22 COVID-19 patients with multiple organ failure in ICUs. The treatment reduced mortality to 50% (compared to 81% in the control group), while patients who used the device for more than 96 hours saw an even lower mortality rate of 31%.
The company used COVID-19 complications to demonstrate how safe and effective the SCD is in treating hyperinflamation across different organs regardless of the cause, whether it be viral, bacterial or from trauma or surgery.