Humacyte, Inc.

Humacyte Strengthens Intellectual Property Portfolio with Issuance of New U.S. Patent Covering Symvess and Other Bioengineered Tissues

Humacyte was issued U.S. Patent No. 12,742,144 covering manufacturing, sterilization, storage, and shipping of Symvess and other bioengineered tissues, with protection running into 2043. The patent complements the company's existing IP family around product design, composition, and manufacture, including its LUNA200 production systems. The company also reiterated plans to submit a supplemental BLA this year seeking dialysis access as a second indication for Symvess, which won FDA approval for vascular trauma in December 2024.

•4d ago

Humacyte at ASN Kidney Week: Phase 3 Trial Built for Women Shows ATEV Advantage Over Fistula, Getting Patients Off Catheters Months Sooner

Humacyte presented positive interim results from the V012 Phase 3 trial at ASN Kidney Week, showing its ATEV beat AV fistula on the primary endpoint of catheter-free days in female hemodialysis patients. Women implanted with the ATEV averaged 220.4 catheter-free days in year one versus 129.3 with a fistula (p<0.001), reached usable access in a median of 1.7 months versus 5.3 months, and had fewer access infections (6 vs 23 per 100 patient-years). The trial met its primary endpoint and enrollment was stopped early. The data, alongside two prior Phase 3 trials, support a supplemental BLA to expand the Symvess label to hemodialysis AV access, targeted for FDA submission this quarter.

•9d ago

Humacyte Provides Commercial Update and Highlights Rapid Acceleration of Symvess Adoption by Hospitals

Humacyte reported that hospitals ordering Symvess rose 44% in Q3 2026, from 34 at the end of Q2 to 49 as of September 30, positioning the company to surpass its goal of adding 20 new hospitals by year-end. The company says new hospital ordering activity increased sequentially each month of the quarter, driven by growing vascular surgeon engagement and expanding contracts. No revenue figures were disclosed; financial detail is deferred to the upcoming Q3 earnings call. Symvess remains the company's sole FDA-approved product, approved for extremity vascular trauma in December 2024.

•17d ago

Humacyte Announces Phase 3 V012 Trial Results for ATEV in Women Requiring Hemodialysis Access Accepted for a Late-Breaking Session Presentation at ASN Kidney Week 2026

Humacyte's interim Phase 3 V012 results for the ATEV in female hemodialysis patients were accepted for a late-breaking oral presentation at ASN Kidney Week 2026 on October 22. V012 is a randomized controlled trial comparing the ATEV with autogenous arteriovenous fistula for dialysis access in women with end-stage kidney disease, presented by Dr. Prabir Roy-Chaudhury of UNC. The V012 data, alongside two prior Phase 3 trials, will support a supplemental BLA to expand the Symvess label to AV access for hemodialysis, targeted for FDA submission this quarter — the actual interim results will not be public until the presentation.

•20d ago

Humacyte Announces FDA Authorization Extending Symvess Shelf Life to 36 Months

The FDA authorized an extension of Symvess expiration dating from 18 months to 36 months when stored refrigerated at 2°C to 8°C, supported by stability data showing the product meets all established quality specifications through the longer period. Humacyte said the doubled shelf life helps hospitals keep Symvess on hand for urgent vascular repairs while simplifying inventory planning and reducing product waste. Founder and CEO Laura Niklason said the authorization supports commercial availability and should further facilitate hospital adoption, ensuring surgeons have access to Symvess when urgent vascular repair is needed. Symvess, a first-in-class off-the-shelf bioengineered vessel approved in December 2024 for extremity arterial trauma, remains investigational outside that indication; Humacyte expects to file a supplemental BLA in November 2026 seeking dialysis access as a second indication.

•1mo ago

Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions

Humacyte confirmed plans to file a supplemental BLA for its ATEV product in dialysis access by November 2026, following constructive discussions with the FDA. The filing will be backed by Phase 3 data from three studies, including V012 results showing women gained an average of three more months catheter-free compared to the standard of care. This represents a potential second indication for the first-in-class product, which was first approved for vascular trauma in December 2024.

•2mo ago

Humacyte Announces Lancet Digital Health Publication of V007 Phase 3 Hemodialysis Access Trial Results

Humacyte announced the publication of V007 Phase 3 trial results in The Lancet Digital Health, demonstrating the superiority of its ATEV bioengineered vessel over standard fistulas for hemodialysis access. The data highlights significant benefits for high-risk patient populations, specifically all women and men with obesity or diabetes, reinforcing positive results previously seen in the V012 trial. Based on these findings, the company plans to submit a supplemental Biologics License Application (sBLA) in the second half of 2026 to expand the Symvess label to include hemodialysis access.

•2mo ago

Board-Certified Vascular and Endovascular Surgeon Performs First Commercial Symvess® Implantation; Cites Bioengineered Blood Vessel as “Revolutionary Advancement”

Humacyte announced the first commercial implants of its bioengineered blood vessel Symvess in Arizona, performed by Dr. Jeromy Brink at Banner University Medical Center. Dr. Brink has completed four implants using the off-the-shelf product, describing it as the most revolutionary advancement in bypass surgery in three decades. CEO Laura Niklason noted that increasing hospital availability of Symvess ensures surgeons have critical treatment options during urgent limb-loss scenarios.

•2mo ago

Humacyte Announces Second Quarter 2026 Financial Results and Provides Business Update

Humacyte reported positive interim Phase 3 data from its V012 trial in female dialysis patients, showing its ATEV product significantly outperformed the standard of care AV fistula, with plans to file a supplemental BLA in the second half of 2026. The company also announced FDA acceptance of an IND for its CTEV product for coronary artery bypass grafting, with a Phase 2a study slated to begin in the third quarter, while Q2 commercial sales of Symvess grew to $0.4 million. Corporate actions included a $57.5 million public offering in June and a restructuring expected to save $14.3 million in 2026, leaving the company with $80.3 million in cash as of June 30.

•2mo ago

Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting

Humacyte announced FDA acceptance of its IND application for the Coronary Tissue Engineered Vessel (CTEV), enabling the initiation of a first-in-human Phase 2a study this quarter. The study will enroll ten adult patients to evaluate the safety and efficacy of CTEV as an off-the-shelf vascular conduit for coronary artery bypass grafting (CABG). This milestone is supported by positive preclinical data and targets a market with over 400,000 procedures annually in the U.S., where no new off-the-shelf conduits have been introduced in 40 years.

•3mo ago

Humacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis Access

Humacyte appointed Dr. Robert J. Kossmann and Dr. Prabir Roy-Chaudhury as advisors to prepare for the commercialization of the ATEV in hemodialysis access. The advisors will assist with health economic, reimbursement, and market access strategies, leveraging their extensive experience in nephrology. These appointments follow positive Phase 3 results from the V012 study and plans to file a supplemental Biologics License Application with the FDA.

•3mo ago

Humacyte's Bioengineered Blood Vessel Outperforms the Standard of Care for Women on Dialysis in Phase 3 Results Presented at the Society for Vascular Surgery Vascular Annual Meeting

Humacyte presented positive Phase 3 results from its V012 study, showing its bioengineered blood vessel (ATEV) outperformed the standard of care (AV fistula) for women on dialysis. Patients receiving ATEV remained catheter-free for an average of 220 days in the first year, compared to 129 days for those with AV fistulas, a statistically significant difference (p=0.00070). Infection rates were also significantly lower in the ATEV group (6 per 100 patient years vs. 23 for AV fistula). Humacyte plans to file a supplemental BLA with the FDA in the second half of 2026 based on this data.

•4mo ago

Humacyte ATEV Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in Female Dialysis Access Patients

Humacyte announced positive interim results from its V012 Phase 3 study of ATEV for dialysis access in female patients, meeting the primary endpoint with high statistical significance. Patients receiving ATEV achieved an average of 220 catheter-free days compared to 129 for the standard-of-care AV fistula, a difference of 91 days (p=0.0007). The ATEV also demonstrated a superior safety profile with an infection rate of 6 per 100 patient years versus 23 for AV fistula, and no study access-associated infections were reported in the ATEV group. Enrollment in the trial will terminate early due to the positive results, and Humacyte plans to file a supplemental Biologic License Application (BLA) with the FDA in the second half of 2026.

•4mo ago

Humacyte Announces Presentation at VASA Meeting of Research Highlighting Self-Repair of ATEV After Cannulation for Dialysis Access

Humacyte presented research at the VASA 2026 Symposium demonstrating that its ATEV product maintains structural integrity and exhibits self-repair via smooth muscle cell repopulation after repeated cannulation. Histological analysis of explants up to 5.5 years post-implantation showed functional tissue remodeling, including capillary ingrowth and organized collagen deposition, alongside greater resistance to bacterial infection compared to ePTFE grafts. The company anticipates releasing top-line interim results from its ongoing V012 Phase 3 study in dialysis access on June 11, 2026, at the Society of Vascular Surgery’s VAM meeting, with a supplemental BLA submission planned for H2 2026 subject to those results.

•5mo ago

Humacyte Announces Symvess® is Now Under Contract with the Strategic Acquisition Center (SAC) of the U.S. Department of Veterans Affairs

Humacyte announced that its FDA-approved product Symvess is now under contract with the U.S. Department of Veterans Affairs' Strategic Acquisition Center (SAC). The SAC SING contract streamlines the procurement process, making Symvess more easily accessible across 170 VA hospitals without requiring individual hospital approvals. This marks a key commercialization step for the company's first-in-class bioengineered vessel, leveraging the VA's preferred sourcing vehicle to accelerate adoption among surgeons treating military veterans.

•5mo ago

Humacyte Appoints Jim Mercadante as Chief Commercial Officer

Humacyte appointed industry veteran Jim Mercadante as Chief Commercial Officer, tasking him with leading the company's commercial strategy and overseeing sales and marketing. The hire comes as Humacyte accelerates the U.S. launch of Symvess, its first FDA-approved bioengineered human tissue for vascular trauma, and prepares for potential future commercial indications. Mercadante brings 25 years of experience and a track record of launching over 50 products, having previously served as CCO at Qure.ai and held leadership roles at Abbott, Johnson & Johnson, and GE.

•6mo ago

Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess® for Vascular Trauma Repair

Humacyte announced that the Israel Ministry of Health has accepted its Marketing Authorization Application for Symvess for arterial trauma repair. The Ministry assigned a 180-working-day review period for the application, citing the existing FDA approval in the U.S. as a basis. This acceptance marks a step in the company's planned global expansion to bring the regenerative medicine product to underserved patients worldwide.

•6mo ago