Five Presentations, One Leading Innovation: Humacyte’s Acellular Tissue Engineered Vessel Takes Center Stage at VEITH 2026

The planned November regulatory submission concerns dialysis access, beyond Symvess’s approved extremity vascular trauma indication.

Rhea-AI Summary

Humacyte (HUMA) will feature its acellular tissue engineered vessel in five presentations at the VEITHsymposium on November 17–21, 2026.

Four presentations on November 18 will cover an infected-field reconstruction case, interim Phase 3 dialysis-access results in women, integrated outcomes from three Phase 3 trials and long-term explant evidence. A November 19 presentation will update Symvess clinical experience in military and civilian trauma settings. Humacyte plans to submit a supplemental biologics license application for arteriovenous access for hemodialysis in November. That use remains investigational.

1 point · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Humacyte plans a November supplemental biologics license application for arteriovenous access for hemodialysis.

Negative

• None.

Argus 15 min delay 9 alerts

+1.12% vs previous close $0.5966 last price 2.6x rel. volume Open Argus

Details

Market Reaction – HUMA

$0.55 – $0.63 Day Range

$165.73M Mkt Cap at Last Price

On Nov 11, the day this news came out, the latest delayed price for HUMA is 1.12% above the previous close. Our momentum scanner has recorded 9 alerts for this stock so far that day. The latest delayed price is $0.60. Relative volume is elevated at 2.6x what this stock usually trades by this time of day.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Historical Context

1 past event · Latest: Oct 23

1 event

1. Oct 23

   Phase 3 results

   24h Move

   +5.4%

   V012 met its primary endpoint, with higher catheter-free days and earlier functional access than fistula.

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

Key Terms

supplemental bla, phase 3, boxed warning, anastomotic failure, +1 more

5 terms

supplemental bla regulatory

"Company slated to submit Supplemental BLA in AV access for hemodialysis in November."

A supplemental BLA is an application to the U.S. regulator asking permission to change an already approved biologic medicine — for example to add a new use, alter dosing, change how it’s made, or update labeling. Investors watch these filings because approval can unlock new sales or lower costs (like adding a popular new feature to an existing product), while denial or delays can limit growth and affect a company’s revenue outlook.

phase 3 medical

"Presentations include interim Phase 3 results in women"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

boxed warning regulatory

"IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE"

A boxed warning is the strongest safety alert a drug regulator places on a medication’s official label to highlight life‑threatening or very serious risks, similar to a bold red flag attached to a product. For investors, it matters because this warning can reduce sales, increase regulatory scrutiny, raise liability and monitoring costs, and change market perception of the drug’s future revenue and risk profile.

anastomotic failure medical

"Anastomotic failure has occurred in patients treated with Symvess."

Anastomotic failure is when a surgical connection between two bodily structures—most often sections of intestine—is unable to hold and leaks, separates, or closes. For investors, it matters because such failures can increase patient complications, lengthen hospital stays, raise treatment costs, trigger product recalls or lawsuits, and slow or block regulatory approvals and market adoption of surgical devices, materials, or therapies designed to create or protect these joins.

thrombosis medical

"Thrombosis has occurred in patients treated with Symvess."

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.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

– Presentations include interim Phase 3 results in women, integrated outcomes from three Phase 3 dialysis access trials and long-term human explant data.

– Podium presentation to provide an update on clinical results with Symvess® in military and civilian trauma settings.

– Company slated to submit Supplemental BLA in AV access for hemodialysis in November.

DURHAM, N.C., Nov. 11, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that its acellular tissue engineered vessel (ATEV) will be featured in five presentations at the 53rd Annual VEITHsymposium, taking place November 17-21, 2026, at the New York Hilton Midtown in New York City. Four abstracts will be presented on Wednesday, November 18, as part of the Associate Faculty program, followed by a podium presentation on Thursday, November 19, on clinical results with Symvess in military and civilian settings.

The VEITHsymposium provides vascular surgeons and other vascular specialists with updates on the most current information about new developments in clinical practice and relevant research. The symposium has over 1,300 presentations on important advancements in the treatment of vascular disease. The ATEV presentations will cover vascular reconstruction in an infected field, interim Phase 3 results in women receiving hemodialysis, integrated durability and safety outcomes across three Phase 3 trials, histologic evidence from explanted vessels, and clinical experience with Symvess in military and civilian vascular trauma.

“Vascular surgeons create dialysis access and repair arteries in some of the most challenging settings, and VEITH puts our data in front of the people who make those decisions. These presentations bring together interim Phase 3 results in women, integrated safety and durability outcomes across three Phase 3 trials, evidence of low atherogenic remodeling from ATEVs that remained in patients long-term, and an update from the trauma surgeons who have used Symvess in military and civilian settings,” said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte.

Presentation Details:

Associate Faculty Program, Session 3: Lower Extremity Arterial – Part 1

• Title: Bioengineered Human Acellular Vessel for Vascular Reconstruction in an Infected Field: A Case Report
• Presenter: Rishi Kundi, M.D., University of Maryland School of Medicine
• Date and time: Wednesday, November 18, 2026, 11:32 AM ET
• Location: Concourse A, Concourse Level, New York Hilton Midtown

Associate Faculty Program, Session 5: Arterial-Venous Access

• Title: Randomized Controlled Trial of Acellular Tissue Engineered Vessel vs. Arteriovenous Fistula for Hemodialysis Access in Females with End-Stage Kidney Disease: Phase 3 CLN-PRO-V012 Interim Analysis
• Presenter: Young Erben, M.D., Mayo Clinic, Jacksonville, Florida
• Date and time: Wednesday, November 18, 2026, 2:22-2:27 PM ET
• Location: Concourse A, Concourse Level, New York Hilton Midtown
  
• Title: Durability and Safety of Acellular Tissue Engineered Vessels for Hemodialysis Access: Integrated Outcomes from Three Phase 3 Randomized Trials
• Presenter: Mohamad A. Hussain, M.D., Ph.D., Mass General Brigham
• Date and time: Wednesday, November 18, 2026, 2:28-2:33 PM ET
• Location: Concourse A, Concourse Level, New York Hilton Midtown
  
• Title: Long-Term Human Explant Evidence of Low Atherogenic Remodeling in Acellular Tissue Engineered Blood Vessels (ATEV)
• Presenter: Alexis Lauria, M.D., RPVI, Medical College of Georgia at Augusta University
• Date and time: Wednesday, November 18, 2026, 2:34-2:39 PM ET
• Location: Concourse A, Concourse Level, New York Hilton Midtown

Podium Presentation Session 50

• Title: Update On The Clinical Results And The Future Of A Tissue Engineered Biologic Vascular Conduit (Formerly The Human Acellular Vessel – Now Symvess) In Military And Civilian Settings
• Presenter: Todd E. Rasmussen, M.D., FACS, Mayo Clinic, Rochester, New York
• Date and Time: Thursday, November 19, 2026, 11:50 AM ET
• Location: Grand Ballroom East, 3^rd Floor, New York Hilton Midtown
• Date and time: Thursday, November 19, 2026, 11:50 AM ET
  

INDICATION

Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: GRAFT FAILURE

Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.

CONTRAINDICATIONS

DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. 

WARNINGS AND PRECAUTIONS

• Graft Rupture
  

Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia.

• Anastomotic Failure
  

Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin.

• Thrombosis
  

Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess.

• Transmission of Infectious Diseases
  

Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing.

ADVERSE REACTIONS

The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain.

Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for Symvess.

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.

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.

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 September 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

FAQ

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

What will Humacyte present at VEITHsymposium 2026?

Humacyte’s vessel will feature in five presentations covering dialysis access, vascular reconstruction and trauma care. Four presentations are scheduled for November 18, with a November 19 podium presentation updating clinical results with Symvess in military and civilian settings.

When does Humacyte plan to submit its dialysis-access application?

Humacyte plans to submit a supplemental biologics license application in November 2026 for arteriovenous access for hemodialysis. This use of the acellular tissue engineered vessel remains investigational and is not approved for sale.