Humacyte Announces Lancet Digital Health Publication of V007 Phase 3 Hemodialysis Access Trial Results
Rhea-AI Summary
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.
Positive
- Phase 3 V007 results published in The Lancet Digital Health, providing peer‑reviewed validation of ATEV data
- ATEV showed superiority to autogenous AV fistula at one year, particularly for all women and men with obesity and diabetes
- V012 Phase 3 trial met its primary superiority endpoint in women needing hemodialysis access
- Humacyte plans an sBLA in H2 2026 to expand the Symvess label to a second AV access indication
- ATEV already FDA‑approved for extremity vascular trauma, supporting the platform’s regulatory track record
- ATEV holds RMAT and Fast Track designations for AV access, potentially supporting future regulatory interactions
Negative
- For AV access in hemodialysis, ATEV remains investigational and is not yet approved for sale outside trauma use
- Planned sBLA submission targeted for H2 2026 indicates additional time before any potential new AV access indication
News Explained
The release also records positive two-year V007 results announced in
Market reaction after V007 Phase 3 clinical data: HUMA +4.74%
Following this news, HUMA has gained 4.74%, reflecting a moderate positive market reaction. The stock is currently trading at $0.61. Trading volume is above average at 1.7x the average, suggesting increased trading activity.
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Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 27 | Phase 2a study initiation | Positive | +7.9% | FDA accepted IND for first-in-human Phase 2a CTEV coronary bypass grafting study. |
| Jun 15 | Phase 3 trial results | Positive | +1.4% | Phase 3 V012 endpoint success supported planned dialysis-access supplemental BLA filing. |
| Jun 10 | Phase 3 interim results | Positive | -19.4% | Interim V012 analysis met superiority endpoint versus AV fistula in women. |
| Nov 20 | Clinical results presentation | Positive | -4.3% | Positive VEITHsymposium clinical presentations reported durable patency and limb salvage findings. |
| Nov 10 | Phase 3 two-year results | Positive | +1.5% | Two-year V007 results showed superior access duration in specified high-risk groups. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific clinical-trial announcements averaged a -2.57% reaction across five events, with both positive and negative outcomes observed.
Key Terms
acellular tissue engineered vessel medical
arteriovenous fistula medical
supplemental biologics license application regulatory
regenerative medicine advanced therapy regulatory
fast track designation regulatory
end-stage renal disease medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes –
– Publication provides peer-reviewed validation for V007 Phase 3 data, and complements recent release of Phase 3 V012 data showing ATEV outperformed standard of care for women on dialysis –
DURHAM, N.C., Aug. 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 the publication of one-year results from the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for hemodialysis patients in The Lancet Digital Health, a leading peer-reviewed journal in the Lancet family.
The publication, titled "A Multi-center Randomized Trial of a Bioengineered Acellular Tissue Engineered Vessel versus Autogenous Fistula for Hemodialysis Access," demonstrates the positive findings from Humacyte's V007 trial, previously presented at major medical conferences, showing the superiority of the ATEV over autogenous arteriovenous fistula (AVF) for hemodialysis vascular access after one year of follow up, particularly for all female patients and male patients with obesity and diabetes, groups that often face higher rates of AVF failure.
"Reliable hemodialysis access is critical for patients with end-stage kidney disease, yet remains a challenge for many, especially those with higher risk profiles," said Mohamad A. Hussain, M.D., Ph.D., lead author of the publication and Vascular and Endovascular Surgeon at Heart and Vascular Institute, Mass General Brigham and Associate Professor of Surgery at Harvard Medical School. "This publication in The Lancet Digital Health provides additional validation of these results and highlights the potential of ATEV as an alternative for patients who may be less likely to benefit from AV fistulas.”
“Publication in The Lancet Digital Health is a significant milestone for Humacyte and an important validation of our Phase 3 dialysis data. These results demonstrate that the ATEV can offer a better option for the patients who need it most, particularly all women and men with obesity and diabetes, who too often face poor outcomes with traditional fistulas,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “With the V007 and V012 results we believe we have built a compelling case to bring this technology to the patients who stand to benefit most.”
Positive two-year results from the V007 Phase 3 trial, announced in November 2025 at the American Society of Nephrology’s Kidney Week 2025, further demonstrated the durability of ATEV's benefits over time. Additionally, Humacyte reported top-line interim results from its V012 Phase 3 study June 11, 2026 at the Society of Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM) in Boston. V012 is specifically focused on female patients with end-stage renal disease (ESRD) needing hemodialysis — a population in which the V007 one-year data already showed meaningful advantages for ATEV over traditional fistulas. Aa a result of meeting the primary superiority endpoint in V012, Humacyte plans to submit a supplemental Biologics License Application (sBLA) to expand the Symvess® label to include a second indication in AV access for hemodialysis in the second half of 2026.
For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended June 30, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
