Business
Humacyte First Quarter 2023 Financial Results and Business Update
- Human Acellular Vessel™ (HAV™) granted second RMAT designation by the FDA, for Vascular Trauma - - Completion of enrollment in Phase 3 trial of HAV in
About this update from Humacyte, Inc.
[{"type":"text","content":"- Human Acellular Vessel™ (HAV™) granted second RMAT designation by the FDA, for Vascular Trauma - - Completion of enrollment in Phase 3 trial of HAV in Hemodialysis Access in End-Stage Renal Disease Patients - - Conference call and live webcast at 8:00 a.m. ET today - DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced financial results for the first quarter ended March 31, 2023, and highlighted recent corporate accomplishments. \"We are off to a fast start in 2023 and have moved closer to our planned filing of a Biologics License Application (BLA) for accelerated approval with the U.S. Food and Drug Administration (FDA) of our Human Acellular Vessel (HAV) for an indication in extremity vascular trauma,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “We were pleased to receive our second RMAT designation from the FDA, for use of the HAV in urgent arterial repair following extremity vascular trauma. The RMAT designation provides a higher likelihood for priority review of our planned BLA filing. We were delighted to see the potential benefits of the HAV reflected in two recent publications, The Lancet Regional Health - Europe and the Journal of Trauma and Acute Care Surgery. Lastly, I wanted to acknowledge JDRF International for their support of our Biovascular Pancreas (BVP) preclinical program in Type 1 diabetes.” First Quarter 2023 and Recent Corporate Highlights Clinical Updates Progress toward planned BLA filing of HAV in vascular trauma – In May 2023, Humacyte was granted the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for the HAV for urgent arterial repair following extremity vascular trauma. The RMAT designation allows for more interactions with the FDA and expedited development and review of regenerative medicine products within the U.S., including the potential for priority review process for a BLA. The RMAT designation comes as Humacyte is nearing the anticipated completion of enrollment in its Phase 2/3 V005 clinical trial of the HAV in the repair of civilian vascular trauma, a study being conducted at Level 1 Trauma Centers in the U.S. and Israel. Currently, a total of 66 patients have received the HAV ...