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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) 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.
Humacyte, Inc. (Nasdaq: HUMA) will host a KOL webinar on Human Acellular Vessels (HAV™) for vascular trauma on July 14, 2022. Esteemed speakers, Dr. Ernest E. Moore and Dr. Gregory A. Magee, will discuss the current treatment landscape and share patient case studies. HAV aims to provide off-the-shelf replacement vessels for vascular reconstruction, eliminating the need for internal harvesting and showing promise in clinical trials for being non-immunogenic and infection-resistant. More than 460 patient implantations have been conducted, with HAV currently in two Phase 3 trials.
Humacyte, Inc. (HUMA) reported significant advancements in its Human Acellular Vessel (HAV) for vascular treatments, with nearly 500 patients implanted and over 1,000 patient-years of follow-up. The HAV, designed to be durable and infection-resistant, is being evaluated in late-stage trials for arteriovenous access, peripheral arterial disease, and vascular trauma. Recent publications in JAMA Surgery and Annals of Vascular Surgery highlight its innovative nature and clinical efficacy, showcasing no infections or failures thus far. The HAV remains an investigational product and is not FDA-approved yet.
Humacyte, Inc. (Nasdaq: HUMA) has appointed Diane Seimetz, Ph.D., to its board of directors. Dr. Seimetz brings over 22 years of international drug development experience, including her role as co-founder and CEO of Biopharma Excellence. The board chair, Kathleen Sebelius, emphasizes that her expertise will be crucial as Humacyte moves towards the commercialization of its Human Acellular Vessel (HAV). The HAV, currently in late-stage clinical trials for various vascular applications, has received FDA's Regenerative Medicine Advanced Therapy and Fast Track designations.
Humacyte, Inc. (Nasdaq: HUMA) announced the successful implantation of two Human Acellular Vessels (HAV) in wounded Ukrainian patients as part of its humanitarian initiative. The HAVs were provided to aid in treating vascular trauma injuries, showcasing their durability and infection resistance. The cases of the patients, one with shrapnel and the other with a gunshot wound, contribute to real-world evidence supporting HAV treatment. As a priority designation by the U.S. Secretary of Defense, HAVs are currently under evaluation in a Phase 2/3 trial for vascular trauma.
Humacyte, Inc. (Nasdaq: HUMA) presented data at the American Transplant Congress 2022 indicating that its investigational Human Acellular Vessel (HAV) does not increase calculated panel reactive antibodies (cPRA), a key measure linked to transplant rejection risk. The collected data from over 500 patient-years show no evidence of PRA sensitization in more than 470 patients implanted with the HAV. This suggests improved patient outcomes and validates the HAV's potential as a durable, non-immunogenic option for vascular repair. The HAV is currently in late-stage clinical trials.
Humacyte, Inc. (Nasdaq: HUMA) announced that Dale Sander, CFO, and Heather Prichard, COO, will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 10:30 a.m. ET in Miami. The conference will be available both in-person and virtually. Humacyte is a clinical-stage biotechnology company focused on developing bioengineered human tissues for medical applications. Their product, human acellular vessels (HAVs), is in late-stage clinical trials and has received FDA designations for vascular trauma and hemodialysis access.
Humacyte announced Q1 2022 financial results and recent achievements, including shipping Human Acellular Vessels (HAVs) to six hospitals in Ukraine for treating vascular trauma, amidst ongoing humanitarian efforts. Newly appointed Chief Medical Officer Shamik Parikh will lead clinical development. Financial highlights show a revenue increase to $233,000, with a net loss of $19.8 million, slightly down from $20.3 million in Q1 2021. The company has cash reserves of $206.2 million, sufficient to fund operations through 2024, supporting their plans for HAV market entry.
Humacyte, Inc. (Nasdaq: HUMA) has initiated the shipment of Human Acellular Vessels (HAVs) to six hospitals in Ukraine, addressing vascular injuries in civilians and soldiers. This initiative follows a request from Ukrainian surgeons and involves coordination with the FDA and Ukraine's Ministry of Health. The HAV is under evaluation in Phase 2/3 trials for vascular trauma and has received priority designation from the U.S. Secretary of Defense. Although investigational, this effort aims to gather real-world evidence of the HAV's potential benefits.
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