SeaStar Medical Reaches Halfway Enrollment Milestone in Pivotal NEUTRALIZE-AKI Trial for Acute Kidney Injury
SeaStar Medical has reached the halfway point in its NEUTRALIZE-AKI pivotal trial, enrolling 100 of the planned 200 adult patients with acute kidney injury requiring continuous renal replacement therapy.
UNMC Researcher to Present Groundbreaking ICU Care Bundle Implementation Study at NIH
Dr. Michele Balas from UNMC College of Nursing will present research on implementing the ABCDEF Bundle in intensive care units at the NIH Pragmatic Trials Collaboratory Grand Rounds.
SeaStar Medical Secures $6M Funding to Advance Novel Extracorporeal Inflammation Therapies
SeaStar Medical has successfully closed a $6 million registered direct offering, strengthening its financial position to advance its cell-directed extracorporeal therapy development.
FDA Approves SeaStar Medical's SCD-ADULT Feasibility Study for Cardiorenal Syndrome
The FDA has approved SeaStar Medical's IDE application for SCD-ADULT to assess safety and efficacy in reducing inflammation in adults with acute heart failure.
SeaStar Medical's Selective Cytopheretic Device Receives FDA Breakthrough Designation for ESRD Inflammation
SeaStar Medical's Selective Cytopheretic Device (SCD) has been granted Breakthrough Device designation by the FDA for treating inflammation in end-stage renal disease (ESRD).
SeaStar Medical's SCD Shows Multibillion-Dollar Market Potential Across Multiple Indications
SeaStar Medical estimates a $25 to $33 billion U.S. market for its Selective Cytopheretic Device (SCD) across five indications, pending FDA approvals.
SeaStar Medical's SCD Receives FDA Breakthrough Designation for Chronic Dialysis
SeaStar Medical's Selective Cytopheretic Device (SCD) has received its fourth FDA Breakthrough Device Designation for treating chronic systemic inflammation in end-stage renal disease patients undergoing chronic hemodialysis.
SeaStar Medical's SCD Receives FDA Breakthrough Device Designation for ESRD Treatment
SeaStar Medical's SCD device receives FDA Breakthrough Device Designation for treating chronic systemic inflammation in end-stage renal disease (ESRD) patients undergoing hemodialysis.
SeaStar Medical's SCD Receives FDA Breakthrough Device Designation for Chronic Dialysis
SeaStar Medical's Selective Cytopheretic Device (SCD) has received Breakthrough Device Designation from the FDA for treating chronic systemic inflammation in end-stage renal disease (ESRD) patients undergoing chronic hemodialysis.
SeaStar Medical Advances AKI Trial with New Site Activations and Enrollment Milestones
SeaStar Medical activated its 14th clinical site for the NEUTRALIZE-AKI pivotal trial, evaluating the Selective Cytopheretic Device (SCD) in adult patients with acute kidney injury (AKI).