Business
Humacyte Announces Fourth Quarter and Year End 2022 Financial Results and Business Update
-- Enrollment Nearing Completion in Human Acellular Vessel™ (HAV™) Phase 2/3 Trial in Vascular Trauma and Phase 3 Trial in Arteriovenous (AV) Access in
About this update from Humacyte, Inc.
[{"type":"text","content":"-- Enrollment Nearing Completion in Human Acellular Vessel™ (HAV™) Phase 2/3 Trial in Vascular Trauma and Phase 3 Trial in Arteriovenous (AV) Access in Hemodialysis Patients -- Multiple publications and scientific meeting presentations highlighting clinical and preclinical HAV results – -- Conference call and live webcast at 8:00 a.m. ET today – DURHAM, N.C., March 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2022, and highlighted recent corporate accomplishments. \"During 2022, we continued to make significant progress across all of our clinical programs and are poised to maintain this momentum throughout 2023,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “With enrollment approaching completion in our Phase 2/3 trial of the HAV in its vascular trauma indication, we have moved substantially closer to our anticipated filing of a Biologics License Application (BLA) in this indication. The potential of the HAV in vascular trauma was highlighted in a compelling key opinion webinar we hosted in December, featuring Ukrainian surgeons Drs. Oleksandr Sokolov, Vasyl Shaprynskyi, and Oleksandr Stanko. We extend our sincere thanks to our Ukrainian colleagues for sharing their experiences using the HAV to treat patients with wartime vascular trauma. In addition to our vascular trauma indication, we are excited to be nearing completion of enrollment in our Phase 3 trial of the HAV in arteriovenous access for hemodialysis patients, with topline results anticipated one year following completion of enrollment. Finally, we continue to be encouraged with the preclinical progress of our small diameter HAV in coronary artery bypass grafting (CABG), which we believe further supports the utility of our HAV as a vascular conduit across multiple indications.\" Fourth Quarter 2022 and Recent Corporate Highlights Clinical Updates Enrollment nearing completion in Phase 2/3 V005 trial in vascular trauma – A total of 63 patients have received the HAV in the Company’s Phase 2/3 V005 trial in vascular trauma. In addition, 17 vascular trauma patients have be...