Humacyte, Inc. reports commercial, clinical and regulatory developments for its bioengineered human tissue platform. The company’s first FDA-approved product, Symvess, is an acellular tissue engineered vessel indicated for treatment of extremity vascular trauma, while other ATEV applications remain part of its broader regenerative medicine pipeline.
Recurring updates include Symvess commercialization, hospital access and distribution arrangements, international regulatory submissions, and clinical work in arteriovenous access for hemodialysis patients. Humacyte also reports quarterly financial results, business-development activity, financing actions and leadership changes tied to its transition from platform development to commercial-stage biotechnology operations.
Humacyte (HUMA) reported a 44% third-quarter increase in hospitals that have ordered Symvess, its FDA-approved vessel for vascular trauma. The total rose from 34 hospitals at the end of the second quarter to 49 as of September 30, 2026. New hospital ordering activity increased sequentially each month of the third quarter.
Humacyte said the adoption trend shows potential to surpass its goal of adding 20 new hospitals by year-end and expects substantial growth through the remainder of 2026. Its revised commercial strategy began in the second quarter. Symvess is approved for adults with extremity arterial injury who need urgent restoration of blood flow to avoid imminent limb loss and cannot receive a graft made from their own vein. Further commercial updates are planned for the third-quarter earnings call.
Humacyte (HUMA) will present interim Phase 3 V012 trial results at an ASN Kidney Week late-breaking session on October 22, 2026. The randomized trial compares its acellular tissue engineered vessel (ATEV), a bioengineered blood vessel, with an arteriovenous fistula, a connection made from a patient's own blood vessels, for hemodialysis access in women with end-stage kidney disease. Prabir Roy-Chaudhury of the University of North Carolina at Chapel Hill will present the findings in Denver.
V012 results and two previously completed Phase 3 hemodialysis-access trials form the clinical foundation for a planned supplemental application to expand the Symvess label to include this use. Humacyte targets submission to the FDA this quarter. ATEV remains investigational for hemodialysis access; its existing FDA approval covers extremity vascular trauma.
Humacyte (HUMA) appointed Scott Coward and Paul Kuznik to its board of directors as it prepares a dialysis-access launch.
Coward joined the Audit Committee. He previously held executive and board roles at Exact Sciences, where he led the integration of Genomic Health following its acquisition. Kuznik joined the Commercial Committee. He previously led Bolton Medical and held U.S. and North American leadership roles at Terumo Aortic. Humacyte is expanding its ongoing Symvess launch and said it plans a U.S. commercial launch of its acellular tissue engineered vessel, or ATEV, for dialysis access. That use remains investigational and is not approved for sale by the FDA or any other regulator. ATEV is approved for extremity vascular trauma.
Humacyte (HUMA)/b) will participate in a fireside chat at the H.C. Wainwright 28th Annual Global Investment Conference in New York on September 16, 2026, at 11:00 a.m. Eastern Time.Management will also be available for one-on-one investor meetings during the event at the Lotte New York Palace Hotel. A live webcast of the presentation and a replay for a limited time will be accessible through the Events & Presentations section of Humacyte’s website.
Humacyte is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues. Its acellular tissue engineered vessel (ATEV) for vascular trauma received FDA Biologics License Application approval in December 2024 and holds priority designation from the U.S. Secretary of Defense. Additional ATEV programs are in late-stage clinical trials for arteriovenous access in hemodialysis and peripheral artery disease, and in preclinical development for several cardiovascular and metabolic indications.
Humacyte (HUMA) received FDA authorization to extend the refrigerated expiration dating of Symvess (acellular tissue engineered vessel, ATEV) from 18 months to 36 months when stored at 2°C to 8°C (36°F to 46°F).
The longer shelf life is supported by additional stability data showing Symvess continues to meet all established quality specifications throughout the 36‑month period under approved storage conditions. The company states that the extended dating may help hospitals maintain Symvess inventory for urgent vascular repairs, simplify inventory planning, and reduce product waste while keeping storage requirements and approved clinical use unchanged.
Symvess remains FDA‑approved only as a vascular conduit for adults with extremity arterial injury requiring urgent revascularization when an autologous vein graft is not feasible; other uses are investigational.
Humacyte (Nasdaq: HUMA) plans to file a supplemental Biologics License Application (BLA) with the FDA in November 2026 to seek a second indication for its acellular tissue engineered vessel (ATEV) in dialysis access, following its December 2024 FDA approval for vascular trauma.
According to Humacyte, the filing will be supported by three Phase 3 studies (V012, V007, V006). In the V012 dialysis access study in women, ATEV recipients had an average of three more months without a dialysis catheter than those receiving arteriovenous fistula, the current standard of care. The ATEV remains investigational for all uses other than extremity vascular trauma.
Humacyte (Nasdaq: HUMA) announced that one‑year results from its V007 Phase 3 trial of the acellular tissue engineered vessel (ATEV) for arteriovenous (AV) access in hemodialysis patients have been published in The Lancet Digital Health. The multicenter randomized trial compared ATEV with autogenous arteriovenous fistula (AVF) and, according to Humacyte, showed superiority of ATEV for hemodialysis vascular access after one year, especially in all women and in men with obesity and diabetes, who often experience higher AVF failure rates.
The publication adds peer‑reviewed validation to V007 data and complements interim Phase 3 V012 results, in which ATEV outperformed standard of care in women on dialysis and met the primary superiority endpoint. Based on V012, Humacyte plans to submit a supplemental Biologics License Application in the second half of 2026 to expand the Symvess® label to a second indication in AV access. Outside the FDA‑approved extremity vascular trauma indication, ATEV remains investigational and is not approved for sale for other uses.
Humacyte (Nasdaq: HUMA) announced that board-certified vascular and endovascular surgeon Jeromy Brink, MD, has performed the first post‑BLA‑approval Symvess implants in Arizona at Banner University Medical Center in Phoenix, completing four procedures within two weeks of gaining access to the product.
Symvess, an FDA‑approved acellular tissue engineered vessel, is indicated as a vascular conduit for adults with extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and an autologous vein graft is not feasible. The off‑the‑shelf vessel is available on demand in the operating room. Humacyte highlights important safety information, including a boxed warning for graft failure, risks of graft rupture, anastomotic failure, thrombosis, and potential transmission of infectious diseases. Uses outside the approved extremity vascular trauma indication remain investigational.
Humacyte (Nasdaq:HUMA) reported second quarter 2026 results and a broad business update, highlighted by breakthrough interim data from the V012 Phase 3 trial of its acellular tissue engineered vessel (ATEV) in female dialysis patients, where ATEV was observed to outperform AV fistula and significantly reduce catheter use and infections. Based on V012 plus prior V007 results, the company plans to file a supplemental Biologics License Application for dialysis access with the FDA in the second half of 2026.
Humacyte also reported FDA acceptance of its IND for a first‑in‑human Phase 2a CABG study using its coronary tissue engineered vessel (CTEV), expanding its cardiovascular pipeline. Second quarter 2026 Symvess® sales rose to $0.4 million from $0.1 million a year earlier, and first‑half 2026 sales reached $0.9 million versus $0.2 million. The company completed a $57.5 million public equity offering, implemented cost reductions expected to yield about $14.3 million in 2026 savings, and ended June 30, 2026 with $80.3 million in cash, cash equivalents and restricted cash, despite reporting a quarterly net loss of $36.8 million.
Humacyte (Nasdaq: HUMA) will release financial results for the three and six months ended June 30, 2026 on Wednesday, August 12, 2026, followed by a webcast and conference call at 8:00 a.m. Eastern Time to provide corporate and financial updates.
Humacyte develops universally implantable, bioengineered human tissues. Its Biologics License Application for Symvess, an acellular tissue engineered vessel (ATEV) for vascular trauma, was approved by the FDA in December 2024. Other ATEV applications remain in late-stage trials or preclinical development and, except for extremity vascular trauma, are investigational.