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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), a clinical-stage biotechnology company developing universally implantable, bioengineered human tissue, will release its Q2 2024 financial results on August 13, 2024. The company will host a webcast and conference call at 8:30 a.m. ET to discuss recent corporate updates from its acellular tissue engineered vessel (ATEV) programs. Investors can join via phone (U.S.: 1-877-704-4453, International: 1-201-389-0920, Conference ID: 13747913) or webcast. A replay will be available on the company's investor website for at least 30 days after the event.
Humacyte (Nasdaq: HUMA) announced that the FDA requires additional time to review its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in vascular trauma treatment. The FDA granted Priority Review in February 2024 with a PDUFA date of August 10, 2024. Despite active engagement and inspections, the FDA couldn't complete the review by the PDUFA date due to ATEV being a first-in-class product.
ATEV is designed as a universally implantable vascular conduit for arterial replacement and repair, available off-the-shelf. The BLA included positive results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from Ukraine. ATEV showed high patency rates and low amputation and infection rates in both civilian and military clinical studies.
Humacyte (Nasdaq: HUMA) announced positive top-line results from its V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV) for arteriovenous access in hemodialysis patients. The ATEV demonstrated superior function and patency at six and 12 months compared to the current standard of care, autogenous fistula.
Key findings include:
- 81.3% of ATEV patients had functional patency at 6 months vs 66.4% for AV fistula
- 68.3% of ATEV patients had secondary patency at 12 months vs 62.2% for AV fistula
- ATEV patients achieved significantly longer duration of hemodialysis over 12 months
Humacyte plans to discuss potential market authorization with the FDA soon and present detailed results at upcoming medical conferences.
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology company, has strengthened its Board of Directors with the addition of two industry veterans. Dr. John P. Bamforth, former Chief Marketing Officer at Eli Lilly, and Dr. Keith Anthony Jones, Chief Physician Executive of the University of Alabama at Birmingham Health System, have joined the board.
This strategic move comes as Humacyte prepares for the planned commercial launch of its Acellular Tissue Engineered Vessel (ATEV™) for vascular trauma. Dr. Bamforth brings extensive commercialization and brand-development expertise, while Dr. Jones offers valuable medical and administrative experience. These additions are expected to support Humacyte's transition to commercial operations and the introduction of ATEV into major health systems.
Pluristyx and Humacyte have entered into a license agreement to develop the BioVascular Pancreas (BVP) using Pluristyx’s clinical-grade PluriBank™ induced Pluripotent Stem Cell (iPSC) line. This agreement allows Humacyte to utilize Pluristyx’s panCELLa™ platform, which generates 'hypoimmune' cells for clinical implantation. The partnership aims to create insulin-producing cells to integrate with Humacyte’s Acellular Tissue Engineered Vessel (ATEV™), potentially revolutionizing type 1 diabetes treatment. The BVP is designed to deliver and sustain insulin-producing islets inside the body. The Acellular Tissue Engineered Vessel and BVP are investigational and not yet approved by the FDA or other regulatory bodies.
PluriBank™ iPSCs are derived from regulatory-compliant donors and have undergone extensive characterization, expansion, and banking to ensure purity, identity, and genetic integrity. This collaboration aligns with Pluristyx's goal of providing safer and more effective cell therapies.
Humacyte's Acellular Tissue Engineered Vessel (ATEV) has received its third FDA RMAT designation, this time for advanced peripheral artery disease (PAD). The RMAT designation aims to expedite the development and review of regenerative medicine therapies for serious conditions. This follows the FDA's clearance of a new IND application for ATEV in PAD. ATEV is designed for vascular replacement and repair, being universally implantable and ready off-the-shelf. PAD affects the leg arteries, with many patients lacking suitable autologous veins for bypass. ATEV's availability could significantly improve patient outcomes.
Humacyte has presented positive preclinical data for its BioVascular Pancreas (BVP) program, aimed at treating type 1 diabetes. The BVP uses stem cell-derived islets and Humacyte's acellular tissue engineered vessel (ATEV) technology. Preclinical tests on diabetic mice showed these islets restored normal blood sugar levels without adverse safety events. Additionally, non-human primate models demonstrated islet survival and insulin production over three months. The studies are in collaboration with the Diabetes Research Institute at the University of Miami. Humacyte is continuing preclinical studies to advance the BVP for type 1 diabetes treatment.
Humacyte announced the issuance of four new ICD-10-PCS codes by CMS, effective October 1, 2024, for replacing arteries using Humacyte’s Human Acellular Vessel (HAV). These codes cover procedures for both upper and lower extremities. Humacyte is progressing towards a New Technology Add-on Payment (NTAP) application to CMS. Additionally, Humacyte's FDA Priority Review BLA submission for vascular trauma treatment, supported by Phase 2/3 clinical trial results and real-world use in Ukraine, awaits a decision on August 10, 2024. The HAV, now dubbed the 'acellular tissue engineered vessel' (ATEV), is designed for urgent arterial repair and has shown higher patency rates and lower infection rates compared to synthetic grafts. The ATEV is still investigational and not yet FDA-approved.
Humacyte will present at the Jefferies Global Healthcare Conference on June 6, 2024, in New York, NY. The company's Founder, President, and CEO, Laura Niklason, M.D., Ph.D., will lead the presentation at 1:00 p.m. ET. Humacyte specializes in developing bioengineered human tissues and aims to share significant updates and engage in one-on-one meetings. The event will be held at the Marriott Marquis, and a webcast will be available for a time on Humacyte's website.
Humacyte, Inc. (Nasdaq: HUMA) will be participating in upcoming investor conferences in May, with their top executives representing the company. The conferences include H.C. Wainwright BioConnect Investor Conference and Benchmark's 4th Annual Healthcare House Call Investor Conference. The participation aims to showcase their bioengineered human tissue technology on a commercial scale.
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