SeaStar Medical Holding Receives FDA Breakthrough Device Designation

by Warren Seah

SeaStar Medical Holding (SMH) saw a significant boost in its shares, rising by 36% to reach 26 cents, following the announcement that the company has received breakthrough device designation from the U.S. Food and Drug Administration (FDA). This designation applies to SMH’s innovative Selective Cytopheretic Device (SCD), which is a first-in-class cell-directed device.

In the past 12 months, SMH’s stock hit its lowest point at 16 cents on September 11th, resulting in a decline of 98%. However, receiving the breakthrough device designation is expected to accelerate the clinical development and regulatory review process for the SCD, specifically for patients in the hospital intensive care unit suffering from acute or chronic systolic heart failure. These patients also experience worsening renal function due to cardiorenal syndrome or right ventricular dysfunction while awaiting implantation of a left ventricular assist device.

The breakthrough device designation holds great promise for SMH as it allows for a faster track to market approval in this specific patient population. The submission made by SeaStar Medical included a successful first-in-human study. In this study, a patient with severe chronic heart failure, who was ineligible for heart transplantation or left ventricular assist device (LVAD) implantation, underwent treatment with the SCD. The primary endpoint of achieving a successful LVAD implantation was met, and the patient was safely discharged to their home without any serious adverse events related to the SCD.

This news showcases the potential of SeaStar Medical Holding’s Selective Cytopheretic Device to address an unmet medical need and significantly improve patient outcomes for those with acute or chronic systolic heart failure. With FDA recognition and support through the breakthrough device designation, it is hopeful that the SCD will soon be available to help more patients in need.

To stay updated on the progress and future developments of SeaStar Medical Holding and its breakthrough Selective Cytopheretic Device, visit their website at

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