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Acellular tissue-engineered vessel granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD
Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue-engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT…
Humacyte submits Biologics License Application to FDA seeking approval of Human Acellular Vessel
Humacyte today announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not…
Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma
Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. A press release reports that the single-arm clinical trial was a success and showed that the HAV…
Clinical performance of Human Acellular Vessel amid war in Ukraine presented at military research symposium
Clinical outcomes of Humacyte’s investigational Human Acellular Vessel (HAV) were presented at the Military Health System Research Symposium in Kissimmee, Florida (Aug. 14–17), following a year-long humanitarian program in Ukraine. The bioengineered, implantable human tissue-based device was provided to five…
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Humacyte today announced completion of enrollment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair. A press release details…
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair. A press release details…