FDA extends review of Humacyte's blood vessel implant HAV due to positive mid- to late-stage study results.

FDA extends review of Humacyte's human blood vessel implant, HAV. The biologically engineered implant is universal and resistant to infection, replacing damaged blood vessels. The FDA's extension of review was based on a mid- to late-stage study that showed HAV's higher rates of blood flow and lower infection rates compared to synthetic implants. Humacyte estimates that 10,000-30,000 US patients suffer from blood vessel injuries annually.

August 09, 2024
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