Circe Biomedical HepatAssist liver assist device Phase II/III protocol pending at FDA -- IPO.
This article was originally published in The Gray Sheet
Executive SummaryCIRCE BIOMEDICAL HEPATASSIST EXTRACORPOREAL LIVER ASSIST SYSTEM PHASE II/III TRIAL is expected to begin "as early as the third quarter" pending FDA sign-off on a proposed protocol submitted to the agency, the firm says in a preliminary prospectus filed with the Securities and Exchange Commission. The trial would include up to 150 patients with no history of liver disease who experience "rapid liver failure (fulminant hepatic failure or `FHF') or who have received liver transplants that fail to function (primary non-function or `PNF')."
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