Business
Humacyte Reports Fourth Quarter and Year End 2021 Financial Results and Provides Business Update
-- Advancing late-stage clinical and preclinical programs of the Human Acellular Vessel™ (HAV™) and other engineered tissues across several indications – --
About this update from Humacyte, Inc.
[{"type":"text","content":"-- Advancing late-stage clinical and preclinical programs of the Human Acellular Vessel™ (HAV™) and other engineered tissues across several indications – -- Multiple publications and scientific meeting presentations highlighting clinical and preclinical HAV results – -- Conference call and live webcast at 8:00 am ET today – DURHAM, N.C., March 29, 2022 (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 fourth quarter and year ending December 31, 2021, and highlighted recent corporate accomplishments. “We are proud of the significant progress Humacyte made in 2021, advancing our first-in-class regenerative medicine platform and universally implantable human tissues product candidates that we believe have the potential to transform the treatment of acute and chronic disease,” said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. “We were pleased to expand the body of data supporting the potential of the HAV in our vascular clinical programs. In addition, we have pushed forward our preclinical small-diameter cardiovascular surgery product candidates and our biovascular pancreas tissue construct. We look forward to the expected completion of our late-stage clinical studies of the HAV for vascular trauma and arteriovenous (AV) access for hemodialysis as we work toward bringing these innovative engineered tissues to market.” Fourth Quarter 2021 and Recent Corporate Highlights Advanced Program Updates Advancement of the Phase 2/3 trial of HAV in vascular trauma has continued and 50 patients have been enrolled in the study. To date, results observed in this non-blinded trial include a very low rate of infection (approximately 2%), no reports of amputation related to the HAV, and high patency rates. Humacyte also continues to build upon its strong relationship with the U.S. Department of Defense and, if FDA approval is received, expects to supply HAVs for use in treating military personnel as a result of this collaboration. The Company expects to file a Biologics License Application (BLA) for this indication in 2022 or 2023.The Company’s Phase 3 trial of the HAV for AV access for hemodialysis is nearing completion of enrollment,...