- Mr. McElheney brings more than 15 of years’ experience in corporate development and alliance management at biopharma companies. -  - He will work with the Company’s leadership team to expand corporate collaborations to accelerate the development and commercialization of Humacyte’s broad pipeline - DURHAM, N.C., March 26, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial sc ...

DURHAM, N.C., March 23, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the Company will release its financial results for the quarter and year ended December 31, 2025 on Friday March 27, 2026. Management will host a webcast and conference call at 8:00 a.m. Eastern Time to provide a corporate and financial update. TitleHumacyte 2025 Fourth Quarte ...

- Purchase commitment is for a minimum of $1.475 million of Symvess product -DURHAM, N.C., March 19, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has received a minimum purchase commitment of $1.475 million of the Symvess acellular tissue engineered vessel to facilitate a clinical evaluation and outreach program in hospitals within the King ...

Core Insights - Humacyte has submitted a Marketing Authorization Application (MAA) for its acellular tissue engineered vessel, Symvess, to the Israel Ministry of Health for arterial trauma repair, with plans for hospital-by-hospital availability prior to approval [1][2] - The company is preparing for global expansion of Symvess, leveraging FDA approval and clinical results to expedite commercialization in multiple countries, including the Middle East [2] Company Overview - Humacyte, Inc. is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][12] - The company aims to transform medical practices by delivering advanced tissue constructs and organ systems to improve patient outcomes [12] Product Details - Symvess is designed for urgent revascularization in adults with extremity arterial injuries when autologous vein grafts are not feasible, providing an off-the-shelf solution that saves critical surgical time [2][4] - Clinical trials have shown Symvess to have low infection rates and high limb salvage rates, with a notable humanitarian program in Ukraine demonstrating 100% survival and zero amputations among treated patients [2] Regulatory Status - The FDA approved Humacyte's Biologics License Application for Symvess in December 2024, and the product is currently in late-stage clinical trials for other vascular applications [12] - Symvess is still considered investigational for uses beyond FDA approval in extremity vascular trauma [3] Safety Information - Important safety information includes risks of graft failure, thrombosis, and potential transmission of infectious diseases, with common adverse reactions being vascular graft thrombosis, fever, and pain [5][9][11]

Core Insights - Humacyte, Inc. has received dedicated funding from the FY 2026 U.S. Department of Defense Appropriations Act to support the evaluation of biologic vascular repair technologies for military personnel suffering from traumatic vascular injuries [1][2] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at a commercial scale [1] - The company's product, Symvess®, is the only human-derived bioengineered blood vessel approved by the U.S. Food and Drug Administration (FDA) [3] Legislative Support - The FY 2026 National Defense Authorization Act emphasizes the integration of FDA-approved breakthrough vascular repair technologies for traumatic extremity arterial injury repair, highlighting the need for human-derived bioengineered vessels in battlefield scenarios [2] - Congress has shown increased support for Humacyte's medical innovations by allocating funds to advance the availability of this technology for service members [2] Product Efficacy - Symvess has been tested in battlefield conditions, specifically in Ukraine, where it was used to treat patients with severe injuries, resulting in a 100% survival rate, zero amputations, and no conduit infections among 16 patients in a retrospective study [4] - Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed and autologous vein grafts are not feasible [5] Future Developments - Humacyte is developing additional applications for its acellular tissue engineered vessels (ATEVs), including late-stage clinical trials for arteriovenous access for hemodialysis and peripheral artery disease [13] - The company has received various designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for its products [13]

Core Insights - Humacyte, Inc. announced results from a five-year analysis of hospital charges and healthcare costs related to extremity arterial injuries, highlighting the financial burden of preventable complications [1][2][5] Group 1: Financial Impact of Complications - Average hospital charge for extremity arterial injury repair was $316,600 per patient, with preventable complications like amputation and conduit infection increasing charges by approximately $493,000 and $590,000 respectively [1][3] - The average reimbursed cost for extremity arterial injury repair was significantly lower at $75,947, indicating a disparity between hospital charges and reimbursement [3] - Vascular graft infection and amputation resulted in additional hospital charges of $589,921 and $492,986 respectively, with average reimbursements of $84,598 and $116,611 [3] Group 2: Symvess Product Overview - Humacyte's Symvess is an acellular tissue engineered vessel designed for urgent revascularization in extremity arterial injuries when autologous vein grafts are not feasible [4][6] - Symvess has demonstrated low rates of infection and high limb salvage rates compared to historical controls, with infection rates one-ninth and amputation rates one-fifth of those seen with synthetic grafts [4][5] - The product is designed to be available off-the-shelf, which can save critical surgical time in emergency situations [5] Group 3: Clinical and Market Context - The analysis included data from 964 adult patients treated for extremity arterial injuries from 2018 to 2023, prior to the FDA approval of Symvess [2] - The patient cohort had an average age of 36.5 years, with 26% treated using conduits other than autologous vein, indicating a significant market for alternative solutions like Symvess [3][5] - Recent positive results from the V005 Phase 2/3 study of Symvess provide the first long-term data for traumatic arterial repair using a biologic conduit [5]

Core Viewpoint - Humacyte, Inc. plans to file a Marketing Authorization Application (MAA) with the Israel Ministry of Health for its acellular tissue engineered vessel (ATEV™ or Symvess) aimed at arterial trauma repair, with expectations for expedited commercialization in other regions following FDA approval [1][2]. Group 1: Expansion Plans - The expansion of Symvess is driven by requests from surgeons and hospitals in Israel, with plans to extend into Europe and the Middle East [1][2]. - The company anticipates that the FDA approval of Symvess will facilitate faster commercialization pathways in these new territories [2]. Group 2: Clinical Data and Product Features - Positive three-year results from the V005 Phase 2/3 study of Symvess in extremity vascular repair provide the first long-term data in traumatic arterial repair using a biologic conduit [2]. - Symvess is designed to be available off-the-shelf, which is crucial for saving surgical time in emergency situations, and has shown low infection rates and high limb salvage rates [2]. Group 3: Company Overview - Humacyte is focused on developing universally implantable bioengineered human tissues and has received FDA approval for its ATEV in December 2024 for vascular trauma [3]. - The company is also conducting late-stage clinical trials for other vascular applications and has received various designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) [3].

Core Insights - Humacyte, Inc. announced the publication of long-term data on Symvess, a bioengineered vessel, demonstrating high limb salvage rates and low infection rates in extremity arterial trauma patients over a follow-up period of up to 36 months [1][2][3] Group 1: Study Results - The study published in the Journal of Vascular Surgery Cases, Innovations and Techniques found that Symvess maintained structural integrity, exhibited a 92.9% infection-free rate from months 3 to 36, and had limb salvage rates of 87.3% at 12 months and 82.5% at 24 months [1][2] - No deaths, amputations, or mechanical failures were attributed to Symvess, and there was no evidence of spontaneous ruptures or structural failures during the follow-up period [2][3] Group 2: Clinical Significance - The results represent the first prospective long-term data in traumatic arterial repair using an off-the-shelf biologic conduit, providing a reliable alternative when autologous vein grafts are not feasible [3][4] - Symvess is designed to be immediately available off-the-shelf, which is critical in emergency situations where time is of the essence [4] Group 3: Company Overview - Humacyte is developing a biotechnology platform for universally implantable bioengineered human tissues and has received FDA approval for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication [13] - The company is also advancing other vascular applications and has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) designation for its ATEVs [13]

Core Insights - Humacyte, Inc. presented significant findings on its acellular tissue engineered vessel (ATEV™) at the VEITHsymposium, highlighting its potential in vascular applications and regenerative medicine [1][2][3] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][8] - The company received FDA approval for its ATEV in December 2024 for vascular trauma indications and is conducting late-stage clinical trials for other vascular applications [8] ATEV Performance and Clinical Outcomes - ATEV demonstrated the ability to remodel into living vascular tissue, showing progressive recellularization with host cells, which is crucial for its function as a vascular graft [2][3] - In a study involving dialysis patients with Steal syndrome, ATEV showed durable patency and safety, with no graft-related infections or ruptures observed over a follow-up period of up to 35.9 months [3][4] - ATEV was reported to have superior patency and duration of use over two years compared to autogenous fistula in female patients, a subgroup with historically poor outcomes [10] Additional Research Findings - Presentations at the symposium included positive outcomes for ATEV in treating torso arterial trauma and high rates of limb salvage in trauma patients treated under humanitarian programs in Ukraine [4][10] - The ATEV's performance in complex cases suggests it could serve as a biologic alternative when autologous vein is not available, moving towards regenerative solutions in vascular surgery [4][5] Future Directions - Humacyte is exploring additional applications for ATEV, including coronary artery bypass grafts and treatment for type 1 diabetes, indicating a broadening scope of its innovative tissue engineering technology [8]

Core Insights - Humacyte, Inc. is set to present six studies on its acellular tissue engineered vessel (ATEV™) at the upcoming VEITHsymposium, a key event for vascular specialists [1][2][3] Presentation Details - The presentations will cover various applications of ATEV™, including its effectiveness in combat vascular trauma, torso arterial trauma, dialysis access, and long-term clinical use [2][3] - Notable presentations include outcomes from the War in Ukraine, case reports from clinical trials, and a review of published outcomes across multiple vascular indications [2][3] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable bioengineered human tissues and advanced tissue constructs [3] - The FDA approved Humacyte's Biologics License Application for ATEV in December 2024, specifically for vascular trauma [3] - ATEV is currently in late-stage clinical trials for other vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3] - The 6mm ATEV for AV access in hemodialysis was the first to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation [3]