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Humacyte, Inc. (Nasdaq: HUMA) is a pioneering biotechnology company focused on developing a disruptive platform that offers universally implantable bioengineered human tissues and organs. These advanced tissue constructs are designed to enhance patient outcomes and revolutionize the field of medicine. The company’s flagship product, the Human Acellular Vessel (HAV), is an investigational bioengineered tissue aiming to address a variety of severe medical conditions, ranging from vascular trauma repair to chronic conditions such as peripheral artery disease (PAD).
Humacyte has made significant strides in its core business, showcasing recent achievements such as the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the HAV. This submission, supported by positive results from both Phase 2/3 clinical trials and humanitarian efforts in Ukraine, brings the company closer to its goal of commercializing HAV for urgent arterial repair. The company's efforts have demonstrated higher patency rates and lower infection and amputation rates compared to synthetic graft benchmarks.
Financially, Humacyte has shown resilience and strategic planning. The company is preparing for a potential Priority Review by the FDA, which could expedite the HAV's market release. In addition, Humacyte has established a solid foundation by securing partnerships and achieving regulatory designations, such as the FDA's Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations.
Humacyte's pipeline extends beyond vascular trauma repair. The company is also exploring applications of HAV in arteriovenous (AV) access for hemodialysis, coronary artery bypass grafts, and pediatric heart surgery. Preclinical success in these areas suggests a broad potential for the HAV across various medical conditions.
For more detailed information and the latest updates, visit www.Humacyte.com.
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.
Humacyte, Inc. (Nasdaq: HUMA) announced an oral presentation of its Human Acellular Vessel (HAV) by Dr. Todd E. Rasmussen at the 44th ICMM World Congress, held in Brussels on September 7, 2022. The presentation focused on innovations for wartime vascular injuries. Additionally, Humacyte will participate in the HC Wainwright 24th Annual Global Investment Conference on September 14, 2022, in New York. The company continues to advance its acellular tissue technology aimed at treating various vascular conditions and has received multiple designations from the FDA for its HAV products.
Humacyte, a clinical-stage biotechnology company, reported second-quarter 2022 revenue of $1.3 million, up from $0.7 million in 2021. The company successfully implanted its Human Acellular Vessels™ in wounded Ukrainian citizens, reportedly saving limbs. Notable appointments were made to the Board, including Diane Seimetz as a new director and Shamik Parikh as Chief Medical Officer. Despite a net income of $36.9 million for the quarter, the company continues to spend heavily on R&D, totaling $14.7 million for the quarter, reflecting ongoing initiatives and preparations for a commercial launch.
Humacyte, Inc. (Nasdaq: HUMA) will release its financial results for Q2 2022 on August 12, 2022, during a conference call at 8:00 a.m. ET. The call will provide a corporate and financial update. Humacyte is focused on developing bioengineered human tissues for various medical applications, with its human acellular vessels (HAVs) in late-stage clinical trials targeting vascular applications. The HAV has received multiple FDA designations, including Regenerative Medicine Advanced Therapy and Fast Track.
Humacyte, Inc. (Nasdaq: HUMA) announced promising results from a preclinical study on its small-diameter Human Acellular Vessel (HAV) for coronary artery bypass grafting (CABG). Conducted in a non-human primate model, the HAV demonstrated structural integrity and patency for up to six months post-implantation, showcasing host cell remodeling. These findings were presented at the American Heart Association Basic Cardiovascular Sciences Scientific Sessions 2022. The HAV aims to address the limitations of saphenous vein grafts, frequently used in CABG procedures, potentially reducing risks associated with vein harvesting.
Humacyte, Inc. (Nasdaq: HUMA) announced the upcoming presentation of six-month outcomes from a preclinical study of its Human Acellular Vessel™ (HAV™) in coronary artery bypass grafting at the Basic Cardiovascular Sciences (BCVS) Scientific Sessions, scheduled for July 25-28, 2022, in Chicago, IL. The poster entitled 'Tissue-engineered Human Acellular Blood Vessels for Coronary Artery Bypass Grafting' will be presented by Dr. Adam Williams. Humacyte's HAVs are designed for vascular repair and have been used in nearly 500 patient implantations, highlighting their growing clinical significance.
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