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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 promising results from its preclinical study on the 3.5mm Human Acellular Vessel (HAV) for coronary artery bypass grafting (CABG), presented at Advanced Therapies Week 2022. The study showed that the HAVs maintained patency and supported host-cell remodeling in a non-human primate model over six months. This advancement could eliminate the need for vein harvesting, which is critically important in CABG procedures. Humacyte aims to further assess safety and efficacy to facilitate future clinical trials.
Humacyte, Inc. (Nasdaq: HUMA) announced that the results of its first compassionate use cases of the Human Acellular Vessel (HAV) will be presented at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society on January 28, 2022. The study reports outcomes from eight patients with critical limb ischemia who underwent HAV implantation, providing new insights into limb salvage options. The HAVs are in late-stage trials for various vascular applications, emphasizing their significance for patients with limited treatment alternatives.
Humacyte (Nasdaq: HUMA) has announced pivotal preclinical results for its Human Acellular Vessel™ (HAV) in coronary artery bypass grafting (CABG), to be presented at the Advanced Therapies Week conference on January 28, 2022. The HAVs are designed to address the significant need for viable vascular substitutes, especially in patients lacking suitable autologous veins. Over 350,000 CABG surgeries occur annually in the U.S. alone, indicating a substantial market opportunity. This development represents a critical milestone in advancing small-diameter HAVs for CABG procedures.
Humacyte, Inc. (Nasdaq: HUMA) has appointed renowned Surgical Key Opinion Leaders Alan P. Kypson, Luigi Pascarella, and Todd E. Rasmussen to advisory positions to enhance their clinical and educational efforts regarding the Human Acellular Vessel (HAV). The HAV, currently in advanced clinical trials for vascular trauma and other ailments, aims for commercialization in initial vascular indications. These experts will guide the company's pipeline advancements and support its growth strategy in regenerative medicine.
Humacyte, Inc. (Nasdaq: HUMA) announced a published case study on the use of its human acellular vessel (HAV) for treating an infected synthetic vascular graft. The case involved a 42-year-old female patient at Vanderbilt University Medical Center, who showed significant improvement 22 months post-implantation, with no signs of infection. The HAV has been utilized in 20 cases under the FDA’s Expanded Access Program. Humacyte continues to evaluate the HAV in clinical trials for various vascular applications, with over 460 implants performed to date.
Humacyte, Inc. (Nasdaq: HUMA) announced positive results from a preclinical study of its 3.5mm Human Acellular Vessel (HAV) during the American Heart Association’s 2021 Scientific Sessions. The study involved five juvenile primates, showing that all HAVs remained patent and were repopulated with vascular cells over three to six months. Two primates displayed mid-graft dilatations due to a xenogeneic response. The study supports the potential application of HAVs in pediatric heart surgeries and advances Humacyte’s broader vascular platform, indicating successful bioengineering capabilities for small-diameter vessels.
Humacyte announced positive results from a Phase 2 clinical trial of its human acellular vessels (HAVs), produced using the commercial-scale LUNA200 system, showing 83% secondary patency at 12 months post-implantation. The study included 30 end-stage renal disease patients undergoing hemodialysis. Key findings indicate no instances of HAV rupture or failure, and that the LUNA200 platform functions comparably to previous systems. The fully operational facility in Durham, N.C. supports an annual capacity of approximately 40,000 HAVs.
Humacyte, Inc. (Nasdaq: HUMA) announced financial results for Q3 2021, highlighting significant corporate progress, including the completion of its business combination with Alpha Healthcare Acquisition Corp. This deal provided $242M in proceeds. The company is advancing its human acellular vessel (HAV™) programs, with promising developments in treating vascular issues and diabetes. Financially, Humacyte reported a net loss of $31.6M, or $0.72 per share, driven by increased expenses and a non-cash remeasurement of a contingent earnout liability.
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology company, announced that CEO Laura Niklason will present at the Credit Suisse 30th Annual Healthcare Conference on Nov. 10, 2021, at 1 p.m. EST. The presentation will be available for replay for 30 days post-event. Humacyte focuses on developing universally implantable bioengineered human tissue to enhance patient care. Its human acellular vessels (HAVs) are in late-stage trials for various vascular applications and were the first to receive the FDA’s Regenerative Medicine Advanced Therapy designation.
Humacyte, Inc. (Nasdaq: HUMA) announced its participation in several scientific events during November 2021 to share new data on its universally implantable bioengineered human tissue projects. CEO Laura Niklason highlighted advancements in the LUNA200 manufacturing system, aimed at commercializing the Human Acellular Vessel (HAV). Presentations will cover both late- and early-stage programs, including the successful use of HAV in treating severe peripheral arterial disease and its application in pediatric heart defects. Events will feature key insights into ongoing research and development efforts.