Welcome to our dedicated page for Humacyte news (Ticker: HUMA), a resource for investors and traders seeking the latest updates and insights on Humacyte stock.
Humacyte, Inc. (Nasdaq: HUMA) is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale. Its news flow centers on Symvess, an FDA-approved acellular tissue engineered vessel (ATEV™) for extremity arterial injury when autologous vein graft is not feasible, and on the broader clinical and regulatory progress of its ATEV pipeline.
On this page, readers can follow HUMA news related to vascular trauma, hemodialysis access, peripheral artery disease, and other vascular indications where Humacyte’s acellular tissue engineered vessels are being studied. Company announcements frequently cover clinical trial readouts, such as Phase 2/3 and Phase 3 data in trauma and dialysis access, long-term safety and efficacy publications in peer-reviewed journals, and presentations at major medical meetings including the VEITHsymposium and the American Society of Nephrology’s Kidney Week.
Humacyte also issues updates on healthcare economics analyses in extremity arterial injury, highlighting the cost impact of complications like amputation and conduit infection and positioning Symvess as an alternative when vein is not feasible. Additional news items describe humanitarian and real-world use of Symvess in wartime vascular injuries, as well as outcomes in hospital-acquired vascular complications and high-risk patient subgroups.
Investors and clinicians can use this HUMA news feed to track regulatory milestones, such as the FDA approval of the ATEV in vascular trauma, RMAT and Fast Track designations, and planned marketing authorization applications in new territories. Financial and corporate updates, including credit facilities, registered offerings, and sales agreements, are also reported through company press releases and Form 8-K filings. Bookmark this page for an organized view of Humacyte’s latest disclosures on its bioengineered tissue platform, commercial launch activities for Symvess, and ongoing pipeline development.
Humacyte (Nasdaq: HUMA) released a five-year retrospective analysis of hospital charges and payer costs for extremity arterial injury (2018–2023). The average initial hospital charge was $316,600 per patient; graft infection and amputation raised charges by about $589,921 and $492,986, respectively, while average reimbursed costs were far lower ($84,598 for infection, $116,611 for amputation). 26% of repairs used conduits other than autologous vein. Humacyte highlights Symvess as an off-the-shelf biologic conduit with markedly lower infection and amputation rates versus historical controls and reports positive three-year V005 Phase 2/3 results supporting limb salvage benefits.
Humacyte (Nasdaq: HUMA) plans to file a Marketing Authorization Application (MAA) with the Israel Ministry of Health for Symvess (acellular tissue engineered vessel) for arterial trauma repair in Q1 2026. The company expects a 120 working-day review period, citing existing FDA approval of Symvess. Humacyte is coordinating with Israeli surgeons who participated in the V005 Phase 2/3 trial and who have requested product access.
Humacyte said recently published positive three-year V005 results provide the first prospective long-term data for traumatic arterial repair using an off-the-shelf biologic conduit; Symvess is designed for immediate availability and has shown low infection rates and high limb-salvage rates in trauma settings.
Humacyte (Nasdaq: HUMA) announced publication (Dec 22, 2025) of long-term results for Symvess in the Journal of Vascular Surgery Cases, Innovations and Techniques.
The prospective V005 Phase 2/3 study followed 54 extremity arterial trauma patients up to 36 months. Key findings: infection-free rate 92.9% from months 3–36, limb salvage 87.3% at 12 months and 82.5% at 24 months, only three conduit infections, and no spontaneous ruptures or unprovoked structural failures attributed to Symvess.
The device is indicated when urgent revascularization is needed and autologous vein graft is not feasible; prescribing information includes a boxed warning on graft failure and recommendations for antiplatelet therapy.
Humacyte (Nasdaq: HUMA) announced a credit facility up to $77.5 million with Avenue Venture Opportunities Fund II, L.P., including a four-year term and an initial tranche of $40 million fully funded at close.
Proceeds from the initial tranche were used primarily to retire existing debt. An additional $37.5 million of tranches are available subject to revenue, regulatory approvals, liquidity conditions and lender approval for the third tranche. Management cited plans for expanded Symvess use, interim V012 Phase 3 dialysis results, and a first human coronary tissue engineered vessel study in 2026.
Humacyte (Nasdaq: HUMA) presented five podium talks at the 52nd VEITHsymposium on Nov 20, 2025, reporting clinical results for its acellular tissue engineered vessel (ATEV).
Key findings: histology up to 200 weeks post-implant showed progressive host recellularization into multi-layered vascular tissue; four DRIL cases for dialysis steal showed durable patency and safety with follow-up to 35.9 months; 17 wartime extremity trauma patients had continued high patency, 100% limb salvage, and zero conduit infections through two years; a randomized female subgroup showed superior 24-month patency versus autologous fistula; case reports showed feasibility in torso arterial trauma. For uses beyond the FDA-approved extremity vascular trauma indication, ATEV remains investigational.
Humacyte (Nasdaq: HUMA) announced six presentations on its Acellular Tissue Engineered Vessel (ATEV™) at the 52nd Annual VEITHsymposium in New York, November 18-22, 2025. The sessions detail clinical use and histologic evaluation of ATEV across vascular indications, including trauma, dialysis access, distal revascularization, and randomized trial outcomes.
Presentations scheduled for November 19 and 20, 2025, include two-year outcome data versus autologous vein grafts and fistulas, case reports from the CLN-PRO-V005 trial, female-specific two-year randomized trial outcomes, long-term histologic regeneration data, and a review of published outcomes across multiple vascular indications.
Humacyte (Nasdaq: HUMA) reported third-quarter 2025 results and a business update on November 12, 2025. Q3 revenue was $0.753M (including $0.703M from Symvess sales) and nine-month revenue was $1.571M. The company reported Q3 net loss of $17.5M and $19.8M cash at September 30, 2025, with ~$56.5M of net proceeds raised after quarter-end. Symvess commercial launch showed a sales ramp (from $0.1M in Q2 to $0.703M in Q3) with 25 VAC approvals covering 92 hospitals and 16 hospitals ordered product. Clinical and regulatory progress includes positive V007 two-year dialysis data, 109 patients enrolled in V012, planned supplemental BLA submission in H2 2026, and an IND submitted for a CABG first-in-human study in 2026. A new U.S. patent for a bioengineered esophagus was granted, extending IP protection into 2041.
Humacyte (NASDAQ: HUMA) presented positive two-year V007 Phase 3 results for its acellular tissue engineered vessel (ATEV) for hemodialysis arteriovenous access at ASN Kidney Week 2025.
In 242 randomized US patients followed to 24 months, the ATEV showed superior average duration of access use in female patients (15.8 vs 10.0 months, p<0.0137) and in the target high‑risk group of females plus males with obesity and diabetes (14.8 vs 9.1 months, p=0.0114). For all patients, duration was 13.3 vs 12.3 months (p=0.7446). Prior co‑primary endpoints at 6 and 12 months also favored ATEV. Safety was comparable to AV fistula, with low infection rates; ATEV had more thrombosis and stenosis events but most were successfully treated. ATEV remains investigational outside approved trauma use.
Humacyte (Nasdaq: HUMA) will release third quarter 2025 financial results for the period ended September 30, 2025 on Wednesday, November 12, 2025. Management will host a webcast and conference call at 8:00 AM Eastern Time to provide a corporate and financial update. The webcast will be accessible 15 minutes prior to the start time and a replay will be available on the company's investor website for at least 30 days.
Dial-in numbers are provided for U.S. and international investors and a conference ID is listed for access. The event covers the company’s corporate and financial update and is scheduled to coincide with the quarterly results release.
Humacyte (Nasdaq: HUMA) announced publication (Oct 30, 2025) of a study in AAST Trauma Surgery & Acute Care Open comparing Symvess to autologous vein for extremity arterial trauma.
Using matched data from Humacyte trials (V005, V017) and the PROOVIT registry, Symvess showed similar short-term outcomes for patency, limb salvage, infection, and mortality: primary patency 86.6% vs 91.8%, secondary patency 91.0% vs 97.7%, amputation 7.5% vs 8.2%, conduit infection 1.5% vs 0%, and death 4.5% vs 4.5%.
Symvess is indicated as an off-the-shelf conduit when autologous vein is not feasible; safety warnings include graft rupture, anastomotic failure, thrombosis, and requirement for antiplatelet therapy.
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