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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 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.
Humacyte (Nasdaq: HUMA), a biotechnology firm focused on bioengineered human tissue, announced its senior leadership will present at seven significant scientific events in October 2021. CEO Laura Niklason highlighted the advancements in their human acellular vessel (HAV) project, noting its potential across various medical applications. Presentations will cover topics from lung regeneration to vascular access, showcasing the clinical progress of HAV, which is already in Phase 3 trials and has been implanted in over 460 patients. The company aims to connect with industry leaders to discuss pivotal findings and innovations.
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