Humacyte (HUMA) announced that it plans to file an Investigational New Drug, IND, application with the U.S. Food and Drug Administration, FDA, to allow first-in-human clinical testing of the small-diameter acellular tissue engineered vessel, sdATEV, in coronary artery bypass grafting, CABG. The Company’s current plans for filing an IND are based on the outcome of a recent meeting held with the FDA, including agreements reached with the agency. To date only the 6.0mm configuration of the ATEV has been studied in human trials, specifically in studies conducted in vascular trauma repair, arteriovenous, AV, access for hemodialysis, and peripheral artery disease, PAD.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on HUMA:
- HUMA Lawsuit Alert! Class Action Against Humacyte, Inc.
- Humacyte provides update on commerical launch, pricing of Symvess
- Hertz Global Holdings call volume above normal and directionally bullish
- Humacyte price target raised to $17 from $15 at Benchmark
- Humacyte Receives FDA Approval for SYMVESS Launch