SeaStar Medical Announces Receipt Of A Category B Coverage Letter From The U.S. CMS For The NEUTRALIZE-AKI Pivotal Trial Evaluating The Co's Selective Cytopheretic Device In Adults With Acute Kidney Injury
Reimbursement expected to accelerate medical site activations and cover a portion of the Company's NEUTRALIZE-AKI trial costs
DENVER, July 16, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of a Category B Coverage Letter from the U.S. Centers for Medicare & Medicaid Services (CMS) for the NEUTRALIZE-AKI pivotal trial evaluating the Company's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). CMS will pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the trial, which will cover a portion of SeaStar Medical's trial-related costs. Specifically, SeaStar Medical's SCD itself, as well as related and routine items and services, are approved for the purposes of Medicare coverage.