Humacyte Inc Stock Price, News & Analysis

Humacyte (Nasdaq: HUMA) announced publication of long-term real-world results for Symvess treating wartime extremity vascular trauma in Ukraine, published Oct 6, 2025 in Military Medicine. In 17 patients followed up to 18 months the study reported 87.1% patency, 100% limb salvage, and zero infections, amputations, or deaths. The 30-day primary and secondary patency was 93.8%. No immunologic rejection was observed. Symvess is indicated as an off-the-shelf acellular tissue engineered vessel for adult extremity arterial injury when autologous vein is not feasible. Important safety information includes a Boxed Warning for graft failure, risk of thrombosis, anastomotic failure within 36 days in trials, and potential transmissible-agent risk despite negative test results.

Humacyte (Nasdaq: HUMA) has secured a new U.S. patent for its bioengineered esophagus, expanding its intellectual property portfolio. The patent, titled "Tubular Prostheses (Esophagus)," provides protection until 2041 and covers key structural and mechanical attributes for esophageal replacement.

The company has now secured patent coverage for bioengineered trachea, esophagus, and urinary conduits across multiple regions including the United States, Europe, Canada, and Australia. These advanced tissue constructs have been evaluated in early preclinical models, with plans for future testing in large animal models.

The technology is part of Humacyte's broader pipeline, which includes ATEV™, CTEV, and BioVascular Pancreas™ (BVP™), all utilizing the same bioengineering platform as their Symvess™ product. The company plans to seek corporate partnerships to accelerate development.

Humacyte (Nasdaq: HUMA) has published promising preclinical data in JACC: Basic to Translational Science regarding their coronary tissue engineered vessel (CTEV) for coronary artery bypass grafting (CABG). The study, conducted on five adult baboons, demonstrated that all CTEVs remained patent throughout the 6-month study period.

Key findings show the CTEV successfully recellularized with host cells and adapted to match native artery size. The company plans to advance to first-in-human trials, with an IND application to the FDA expected in Q4 2025. This innovation could potentially address the limitations of current saphenous vein grafts, which show approximately 50% failure rate at 10 years.

Humacyte (Nasdaq: HUMA) announced the publication of clinical outcomes in the Journal of Vascular Surgery for patients treated with Symvess™, their FDA-approved bioengineered human tissue vascular conduit. The study focused on 12 patients with hospital-acquired vascular complications from their V005 pivotal Phase 2/3 clinical trial.

Key results showed 92% secondary patency (blood flow) at an average follow-up of 23.3 months, with 100% limb salvage and zero conduit infections. The patients required arterial repair due to various complications including vascular interventions, tumor resections, and orthopedic surgery injuries. Symvess received full FDA approval in December 2024 for use in adults requiring urgent revascularization for extremity arterial injury.

Humacyte (Nasdaq: HUMA) reported Q2 2025 financial results and business updates. The company generated $301,000 in revenue for Q2 2025 and $818,000 for H1 2025. Key highlights include 82 civilian hospitals now approved to purchase Symvess™, and ECAT approval making the product available to 35 Military Treatment Facilities and 160 VA hospitals.

The company implemented cost reduction measures, including a 30-employee workforce reduction, expecting to save approximately $50 million through 2026. Q2 resulted in a net loss of $37.7 million, with cash position of $88.4 million as of June 30, 2025. July product sales of $0.3 million exceeded total H1 sales, showing commercial momentum.

Clinical progress includes positive V007 Phase 3 trial results for dialysis access, particularly strong in high-risk subgroups, and achievement of 100-patient enrollment in the V012 Phase 3 trial.

Humacyte (Nasdaq: HUMA), a clinical-stage biotechnology company focused on developing bioengineered human tissue, has scheduled its Q2 2025 financial results and corporate update for August 11, 2025, at 8:00 AM ET.

The company will host a conference call and webcast, accessible to U.S. investors at 1-877-704-4453 and international investors at 1-201-389-0920 using Conference ID 13754596. The webcast will be available 15 minutes before the call and remain accessible for at least 30 days afterward on the company's investor relations website.

Humacyte (Nasdaq: HUMA) announced its first sale of Symvess to a U.S. Military Treatment Facility, following its recent Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency. The facility serves approximately 200,000 active-duty service personnel, retirees, and family members.

Symvess, an acellular tissue engineered vessel approved by the FDA in December 2024 for extremity vascular trauma, is now available to approximately 35 Military Treatment Facilities and 160 U.S. Department of Veterans Affairs hospitals through the ECAT system, which provides DOD and other federal agencies access to medical products.

Humacyte (Nasdaq: HUMA) has received Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency for its Symvess product. This approval enables healthcare professionals at Department of Defense (DOD) and Veterans Affairs facilities to access Symvess for treating military service members, veterans, and other patients.

Symvess, an acellular tissue engineered vessel, received FDA approval in December 2024 for extremity vascular trauma indication. The ECAT system integration represents a significant milestone in making the product accessible to military healthcare providers. However, for uses beyond the FDA-approved indication, Symvess remains investigational and requires further regulatory approval.

Humacyte (NASDAQ: HUMA) presented results from its V007 Pivotal Phase 3 clinical trial of ATEV (acellular tissue engineered vessel) at the Society for Vascular Surgery Meeting. The study compared ATEV to arteriovenous fistula (AVF) in high-risk patients with end-stage kidney disease requiring hemodialysis. The trial enrolled 242 patients, including 110 high-risk patients. Results showed ATEV demonstrated better functional patency and usability compared to AVFs in high-risk patients (women and men with BMI ≥30kg/m2 with diabetes). While ATEV showed more thrombosis and stenosis events than AVF, these were mostly treatable. The safety profile was comparable to AVF with similar infection rates, and ATEV patients required fewer maturation and surgical revision procedures. The study particularly benefits women and patients with obesity and diabetes, who represent over half the dialysis access market and historically face higher AVF maturation failure rates.