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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. (HUMA) has completed enrollment for its Phase 3 clinical trial, V007, aimed at evaluating the safety and efficacy of the Human Acellular Vessel (HAV) for hemodialysis access in patients with end-stage renal disease (ESRD). The trial involves 240 participants across multiple centers in the U.S. and compares the HAV to autogenous arteriovenous (AV) fistulas. Primary efficacy endpoints include usability assessments at six and twelve months, while secondary endpoints focus on infection rates. The HAV technology aims to provide quicker access to dialysis and reduce reliance on infection-prone catheters. With approximately 786,000 Americans impacted by ESRD, the HAV offers a promising alternative to current vascular access methods, which have significant risks. The product remains investigational and is not yet approved by the FDA.
Humacyte, Inc. (Nasdaq: HUMA) announced financial results for Q4 and the year ended Dec 31, 2022, reporting no revenue in Q4 2022 versus $177,000 in Q4 2021, and $1.6 million for the year, up from $1.3 million in 2021. The company is nearing enrollment completion in its Phase 2/3 HAV trial for vascular trauma, with 63 patients treated and plans for a Biologics License Application (BLA) filing within four months post-trial completion. The Phase 3 trial for AV access in hemodialysis has enrolled 238 patients. Humacyte's cash reserves stand at $151.9 million, expected to fund operations through 2024. Net loss for Q4 2022 was $3.7 million, compared to a net income of $42.6 million in Q4 2021.
Humacyte (Nasdaq: HUMA) will announce its financial results for Q4 and the year ended December 31, 2022, on March 24, 2023, at 8:00 AM ET. A webcast and conference call will follow to provide a corporate and financial update.
Humacyte focuses on developing bioengineered human tissues for various medical applications, notably in vascular treatments. Their human acellular vessels are in late-stage clinical trials and have received important FDA designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track.
DURHAM, N.C., Feb. 27, 2023 – Humacyte, a clinical-stage biotechnology platform company (Nasdaq: HUMA), has announced that CEO Laura Niklason and CFO Dale Sander will represent the company at two upcoming investor conferences in March. The Cowen’s 43rd Annual Health Care Conference will take place from March 6-8, with Humacyte presenting on March 6 at 1:30 p.m. ET. The Oppenheimer’s 33rd Annual Healthcare Conference is scheduled for March 13-15, with a presentation on March 14 at 2:40 p.m. ET. Webcast replays will be available for at least 30 days after each event. Humacyte focuses on developing bioengineered human tissues and advanced organ systems.
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.