What's Going On With Medical Devices Focused SeaStar Medical Stock Today?

SeaStar Medical Holding Corporation ICU shares are trading higher on Thursday, on continued strength after the company received FDA Breakthrough Device Designation for its cell-directed Selective Cytopheretic Device (SCD).

Unlike pathogen removal and other blood-purification tools, the SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes.

SCD is used in hospital intensive care units for patients with acute kidney injury (AKI) and acute on chronic liver failure. On Wednesday, the shares closed almost 70% higher at $0.77.

This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

An investigator-initiated pilot study conducted at the University of Michigan assessed treatment with SCD in two patients with type 1 hepatorenal syndrome. 

Positive clinical outcomes were seen in both cases - one patient with hepatorenal syndrome due to acute alcoholic hepatitis was alive at day 90 after seven days of SCD treatment and undergoing liver transplantation evaluation, and the other patient with hepatorenal syndrome due to non-alcoholic steatohepatitis or NASH had successful liver transplantation six days after SCD therapy ended. 

SeaStar Medical stock is up over 40% on heavy volume, with a session volume of 25 million shares traded, compared to the trailing 100-day volume of 9 million shares.

Price Action: ICU shares are up 42.7% at $1.10 during the premarket session on the last check Thursday.