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

Rhea-AI Summary

Humacyte (Nasdaq:HUMA) presented research at the 2026 VASA dialysis symposium showing its acellular tissue engineered vessel (ATEV) maintained long-term structural integrity and showed self-repair after repeated cannulations, with smooth muscle cell repopulation, tissue remodeling, and evidence of greater resistance to bacterial infection versus ePTFE grafts in explants up to 5.5 years.

Humacyte expects top-line interim results from the V012 Phase 3 dialysis access study, focused on female ESRD patients, on June 11, 2026, and plans a potential sBLA for AV access in the second half of 2026.

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On May 26, the day this news came out, HUMA closed 5.71% above the previous close.

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Key Figures

Annual cannulations: 300 needle punctures Follow-up duration: 5.5 years AV access duration: Up to 5.5 years +5 more

Annual cannulations

300 needle punctures

Typical yearly dialysis access cannulations

Follow-up duration

5.5 years

ATEV explants post-implantation with repeated cannulation

AV access duration

Up to 5.5 years

ATEV and ePTFE samples used as AV conduits

Interim readout date

June 11, 2026

Planned top-line interim V012 Phase 3 dialysis access results

V012 trial phase

Phase 3

Dialysis access study focused on female ESRD patients

V007 trial phase

Phase 3

Completed trial showing advantages of ATEV vs AV fistulas

Planned sBLA timing

Second half of 2026

Target submission for AV access hemodialysis indication

Meeting year

2026

VASA Vascular Access for Dialysis Symposium presentation year

Historical Context

5 past events · Latest: May 20

5 events

1. May 20

   VA contract award

   24h Move

   +8.9%

   VA Strategic Acquisition Center contract improves Symvess access at VA hospitals.

2. May 13

   Earnings and update

   24h Move

   +24.2%

   Q1 results, initial Symvess sales, new commitments, and cost-saving measures disclosed.

3. May 12

   Executive appointment

   24h Move

   -9.0%

   Appointment of Chief Surgical Officer to support clinical adoption of vascular products.

4. May 08

   Earnings date notice

   24h Move

   -1.9%

   Announcement of Q1 2026 results date and webcast details for investors.

5. Apr 27

   KOL event

   24h Move

   +15.1%

   Virtual KOL event to discuss ATEV for AV access and upcoming V012 interim data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cannulation, acellular tissue engineered vessel (ATEV), arteriovenous (AV) fistulas, ePTFE grafts, +4 more

8 terms

cannulation medical

"Dialysis access requires frequent cannulation, often exceeding 300 needle punctures"

Cannulation is the insertion of a small tube or needle into a blood vessel, body cavity or organ to give or remove fluids, monitor pressures, or provide ongoing medical access — like putting a straw into a juice box to reach the liquid inside. It matters to investors because the safety, ease and cost of cannulation affect demand for related devices, hospital procedures, clinical trial operations and insurer payments, so improvements or complications can influence company revenue and regulatory risk.

acellular tissue engineered vessel (ATEV) medical

"self-repair of the acellular tissue engineered vessel (ATEV) after cannulation"

Acellular tissue‑engineered vessel (ATEV) is a lab-made blood vessel scaffold created without living cells, designed to be implanted where a patient needs a replacement artery or vein. Think of it as a ready-made, biofriendly pipe that the patient’s own body gradually lines and integrates; for investors, ATEVs matter because they represent a scalable medical product with potential to reduce surgical complications and long‑term care costs, but they carry regulatory, manufacturing and adoption risks that affect commercial value.

arteriovenous (AV) fistulas medical

"Arteriovenous (AV) fistulas remain the standard of care for vascular access"

An arteriovenous (AV) fistula is a surgically created connection between an artery and a vein, most commonly made to provide durable blood access for long‑term dialysis in people with kidney failure; think of it as redirecting a fast stream into a wider canal so machines can reliably draw and return blood. Investors care because the quality and prevalence of AV fistulas drive demand for related medical devices, surgical services and dialysis care, affect complication and hospitalization rates, and therefore influence provider costs, reimbursement and company revenues in the renal care market.

ePTFE grafts medical

"arteriovenous grafts, including ePTFE grafts, also used as alternatives"

ePTFE grafts are medical-grade synthetic tubes made from expanded polytetrafluoroethylene that surgeons use to replace or bypass damaged blood vessels or to create dialysis access. Think of them as flexible plumbing replacements for the body; their design affects how well tissue accepts the implant and how long it lasts, so clinical performance, regulatory approvals and reimbursement determine adoption and revenue potential for medical-device companies.

pseudoaneurysm medical

"contributing to hematoma, pseudoaneurysm, infection, thrombosis, and stenosis"

A pseudoaneurysm is a contained leak from a blood vessel where blood collects outside the vessel wall but stays confined by surrounding tissue, like a bulge forming beside a cracked pipe. For investors, it matters because its occurrence can affect the safety profile and market acceptance of medical devices, drugs or procedures, influence regulatory reviews, trigger additional treatment costs or recalls, and create reputational or legal risks that can impact a company’s financial outlook.

thrombosis medical

"contributing to hematoma, pseudoaneurysm, infection, thrombosis, and stenosis"

Thrombosis is the formation of a blood clot inside a blood vessel that can block normal blood flow, like a plaster clogging a pipe. It matters to investors because clotting events affect the safety profile and regulatory review of drugs, medical devices and treatments, can drive costly litigation or recalls, and influence healthcare demand and company valuations tied to patient outcomes and product approvals.

stenosis medical

"contributing to hematoma, pseudoaneurysm, infection, thrombosis, and stenosis"

Stenosis is the abnormal narrowing of a body passage or opening—commonly arteries, heart valves, or the spinal canal—that restricts flow of blood, nerves, or other fluids. For investors, stenosis matters because it drives demand for surgeries, implants, drugs and diagnostic tests, affects patient outcomes and treatment costs, and can influence clinical trial results and the sales prospects of medical products tied to treating or diagnosing the condition.

Biologics License Application (sBLA) regulatory

"plans to submit a supplemental Biologics License Application (sBLA) for a second indication"

A biologics license application (sBLA) is a formal request submitted to regulatory authorities seeking approval to market a biological medicine, such as vaccines or therapies made from living organisms. It is a comprehensive package of data showing that the product is safe, effective, and manufactured to high quality standards. For investors, receiving approval signals a potential product launch, which can significantly impact a company's growth and valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- Dialysis access requires frequent cannulation, often exceeding 300 needle punctures annually - 

- The ATEV was observed to maintain long-term structural integrity and self-repair with smooth muscle cell repopulation despite repeated cannulations -

- Humacyte anticipates that top-line interim results from its ongoing V012 Phase 3 study in dialysis access will be available for reporting in June -

DURHAM, N.C., May 26, 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 presentation of research providing evidence of self-repair of the acellular tissue engineered vessel (ATEV) after cannulation for dialysis access at the Vascular Access Society of the Americas (VASA) 2026 Vascular Access for Dialysis Symposium in Salt Lake City, Utah. The presentation, titled “Self-repair of Acellular Tissue Engineered Vessels (ATEV) after Cannulation for Dialysis Access,” was delivered by Maisha Clancy, MA, Process Development Engineer at Humacyte. Research demonstrated that despite repeated cannulations for dialysis access, the ATEV was observed to maintain long-term structural integrity self-repair with smooth muscle cell repopulation in explants up to 5.5 years post-implantation.

Arteriovenous (AV) fistulas remain the standard of care for vascular access in patients undergoing dialysis, with arteriovenous grafts, including ePTFE grafts, also used as alternatives. Both types require frequent cannulation to provide access to the patient’s blood for dialysis, often exceeding 300 needle punctures annually. Repetitive cannulation can damage the conduit wall and endothelium, contributing to hematoma, pseudoaneurysm, infection, thrombosis, and stenosis. Under the research program presented at the VASA meeting, histological characterization of cannulation tracts was performed in explanted ATEV and ePTFE samples that had been used as AV access conduits for up to 5.5 years.

Researchers observed that despite repeated cannulations, ATEVs maintained long-term structural integrity in explants up to 5.5 years post-implantation. Repeated cannulation sites in the ATEVs showed evidence of self-repair, with smooth muscle cell repopulation of the graft wall and access tracts. Functional tissue remodeling occurred at the ATEV cannulation sites, including capillary ingrowth and organized collagen deposition with predominant collagen III expression. Growth factor, glycoprotein, and proteoglycan presence was observed, evidencing matrix regeneration in the ATEVs. In cannulation sites and cannulation adjacent walls, ATEVs were observed to have greater resistance to bacterial infection than ePTFE grafts.

"These findings support the continued evaluation of ATEVs as a potential durable, self-repairing, and infection-resistant vascular access solution for long-term hemodialysis in patients at high risk for AV fistula failure," said Clancy. "The observations of lower grade injury in ATEVs, together with evidence of active cellular repair and bacterial containment, highlights their regenerative capacity and ability to support improved host defenses."

Humacyte anticipates that top-line interim results from its ongoing V012 Phase 3 study in dialysis access will be available for reporting on June 11, 2026 at the Society of Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM) in Boston. The V012 study is specifically focused on female patients with end-stage renal disease (ESRD) requiring dialysis, a population in which results from the completed V007 Phase 3 trial already showed meaningful advantages for ATEV over AV fistulas. Subject to results from the V012 study, Humacyte plans to submit a supplemental Biologics License Application (sBLA) for a second indication in AV access for hemodialysis during 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 plans, anticipated timeline and ability to file applications for, and obtain marketing approvals from, the FDA and other regulatory authorities, including the European Medicines Agency, for our ATEVs and product candidates; 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 and the public perception thereof; the implementation of our business model and strategic plans for 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 March 31, 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What research did Humacyte (HUMA) present at the 2026 VASA dialysis meeting?

Humacyte presented research on its acellular tissue engineered vessel (ATEV) for dialysis access, showing structural integrity and self-repair after repeated cannulations. According to Humacyte, explants up to 5.5 years post-implantation showed smooth muscle cell repopulation and functional tissue remodeling.

How does Humacyte's ATEV respond to repeated cannulation for dialysis access?

Humacyte reports that ATEVs maintained long-term structural integrity despite frequent cannulation, with evidence of self-repair at cannulation sites. According to Humacyte, the graft wall showed smooth muscle cell repopulation, capillary ingrowth, and organized collagen deposition, indicating active tissue regeneration over time.

Did Humacyte's ATEV show differences versus ePTFE grafts in infection resistance?

Yes. According to Humacyte, ATEVs at cannulation sites and adjacent walls were observed to have greater resistance to bacterial infection than ePTFE grafts. Histological analysis also showed matrix regeneration features such as growth factor, glycoprotein, and proteoglycan presence in ATEV samples.

When will Humacyte (HUMA) report V012 Phase 3 dialysis access interim results?

Humacyte anticipates reporting top-line interim results from the V012 Phase 3 dialysis access study on June 11, 2026. According to Humacyte, these data will be presented at the Society for Vascular Surgery’s Vascular Annual Meeting (VAM) in Boston.

What patient population is included in Humacyte's V012 Phase 3 dialysis access trial?

The V012 Phase 3 study focuses on female patients with end-stage renal disease (ESRD) requiring dialysis. According to Humacyte, earlier V007 Phase 3 results in this population showed meaningful advantages for ATEV compared with arteriovenous fistulas in dialysis access.

How could the V012 Phase 3 trial impact future regulatory plans for Humacyte's ATEV?

Subject to V012 results, Humacyte plans to submit a supplemental Biologics License Application (sBLA) for ATEV in arteriovenous access for hemodialysis in the second half of 2026. According to Humacyte, ATEV remains investigational outside its extremity vascular trauma approval.

Is Humacyte's ATEV currently approved for dialysis access indications?

No. For dialysis access and other non-trauma uses, ATEV is still investigational and not approved for sale by the FDA or other regulators. According to Humacyte, ATEV currently holds FDA approval only for an extremity vascular trauma indication.