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Humacyte, Inc. reports commercial, clinical and regulatory developments for its bioengineered human tissue platform. The company’s first FDA-approved product, Symvess, is an acellular tissue engineered vessel indicated for treatment of extremity vascular trauma, while other ATEV applications remain part of its broader regenerative medicine pipeline.
Recurring updates include Symvess commercialization, hospital access and distribution arrangements, international regulatory submissions, and clinical work in arteriovenous access for hemodialysis patients. Humacyte also reports quarterly financial results, business-development activity, financing actions and leadership changes tied to its transition from platform development to commercial-stage biotechnology operations.
Humacyte, Inc. (Nasdaq: HUMA) announced significant findings from a six-year analysis of its Phase 2 clinical trial on human acellular vessels (HAVs). Results published in the Journal of Vascular Surgery – Vascular Science indicate a 60% overall secondary patency rate, with no reported graft rejection, infection, or amputations among patients with critical limb ischemia. The HAV demonstrated mechanical durability and potential for long-term use in restoring blood supply in patients with peripheral artery disease (PAD). Humacyte emphasizes the growing demand for effective PAD treatments, with over 200 million affected globally.
Humacyte, Inc. (Nasdaq: HUMA) is hosting a webinar on December 15, 2022, featuring key Ukrainian surgeons discussing the application of its Human Acellular Vessels (HAV) in treating wartime vascular trauma. The HAV has received priority designation from the U.S. Secretary of Defense for vascular trauma treatment and is designed to be infection-resistant and readily available. Humacyte's HAV is undergoing a Phase 2/3 clinical trial for civilian vascular trauma and has been used in over 460 implantations. However, the HAV remains investigational and has not received FDA approval.
Humacyte, Inc. (Nasdaq: HUMA) announced that Ukrainian surgeons will present on the company's Human Acellular Vessel (HAV) at two major conferences in December 2022. The first presentation will take place at the VI Congress of Vascular Surgeons in Kyiv on December 1, where surgeons will discuss early diagnosis and treatment of vascular injuries. The second presentation will be at the 11th Munich Vascular Conference on December 3, focusing on vascular trauma in Ukrainian war survivors. The HAV is being evaluated in clinical trials for vascular replacement and has been provided to front-line hospitals in Ukraine to aid patients with traumatic injuries.
Humacyte, Inc. (Nasdaq: HUMA) announced participation in the 34th Annual Piper Sandler Healthcare Conference on December 1, 2022. CEO Laura Niklason and CFO Dale Sander will engage in a fireside chat at 12 PM ET in New York City. The event will be accessible via a live webcast, with a replay available for 30 days afterward. Humacyte is focused on developing bioengineered human tissues for treating various medical conditions, with significant advancements in acellular tissue technology, including their human acellular vessels currently in late-stage clinical trials.
Humacyte, Inc. (HUMA) reported progress in clinical development for its Human Acellular Vessel™ (HAV™) aimed at vascular trauma, anticipating a Biologics License Application (BLA) filing by mid-2023. The V005 Phase 2/3 trial demonstrated high patency and low rates of amputation and infection among 56 patients. The company reported a net loss of $25.3 million for Q3 2022, a decrease from the previous year, while revenue reached $31 thousand. The appointment of Lt. General Bruce Green and Dr. Cindy Cao to the board and management is expected to enhance oversight and regulatory strategy.
Humacyte, Inc. (Nasdaq: HUMA) presented promising six-month results of their Human Acellular Vessels (HAV) in a baboon coronary artery bypass grafting (CABG) model at the AHA Scientific Sessions. The HAV grafts showed patency and repopulation with the subjects' own cells, potentially overcoming issues faced by traditional saphenous vein grafts, which have a high failure rate. Additionally, the HAV demonstrates low rates of amputation and infection in clinical trials. The company is preparing for a 2023 BLA submission for vascular trauma and arteriovenous access.
Humacyte, Inc. (Nasdaq: HUMA) will announce its financial results for Q3 2022 on November 10, 2022. Management will provide a corporate and financial update during a conference call starting at 8:00 a.m. ET. Humacyte specializes in developing universally implantable bioengineered human tissues and organs, with ongoing late-stage clinical trials for human acellular vessels (HAVs) aimed at treating various vascular applications. The HAVs have received FDA designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track, indicating promising potential in the market.
Humacyte, Inc. (Nasdaq: HUMA) presented a clinical update on its Human Acellular Vessel (HAV) for vascular trauma at the 36th European Society for Vascular Surgery Annual Meeting in Rome. Surgeons in Ukraine reported utilizing HAV for treating injuries caused by the ongoing war, noting its role in facilitating vascular reconstructions without the need for harvesting veins. Clinical cases demonstrated successful outcomes, with patients recovering post-implantation. HAV has received priority designation from the U.S. Secretary of Defense and is under evaluation in Phase 2/3 trials for vascular trauma.
Humacyte, Inc. (Nasdaq: HUMA) announced significant leadership changes, appointing Lt. General Bruce Green, M.D., USAF-ret., to its Board of Directors and Yang (Cindy) Cao, Ph.D., as Chief Regulatory Officer. Green's military medical background and Cao's extensive experience in drug development position the company well for advancing its Human Acellular Vessels™ (HAV™) technology towards regulatory approval. The HAV™ has shown promise in addressing vascular trauma and has received notable designations from the FDA, positioning Humacyte for critical advancements in regenerative medicine.
Humacyte has announced a clinical update on its Human Acellular Vessel (HAV) presented by Dr. Todd E. Rasmussen at the ICMM World Congress. The HAV aims to improve the treatment of vascular trauma, being infection-resistant and readily available for quick implantation. Over 500 patients have received HAV implants in ongoing clinical trials, which also include humanitarian efforts in Ukraine. The HAV has received FDA designations such as RMAT and Fast Track, indicating its potential in addressing vascular injury, especially in combat scenarios.