Humacyte Announces Publication of Long-Term Results for Ukrainian Patients Treated in Real-World Combat Setting with Symvess™

Rhea-AI Summary

Humacyte (Nasdaq: HUMA) announced publication of long-term real-world results for Symvess treating wartime extremity vascular trauma in Ukraine, published Oct 6, 2025 in Military Medicine. In 17 patients followed up to 18 months the study reported 87.1% patency, 100% limb salvage, and zero infections, amputations, or deaths. The 30-day primary and secondary patency was 93.8%. No immunologic rejection was observed. Symvess is indicated as an off-the-shelf acellular tissue engineered vessel for adult extremity arterial injury when autologous vein is not feasible. Important safety information includes a Boxed Warning for graft failure, risk of thrombosis, anastomotic failure within 36 days in trials, and potential transmissible-agent risk despite negative test results.

Positive

• 87.1% patency at up to 18 months
• 100% limb salvage in 17 treated patients
• Zero infections, amputations, or deaths through 18 months
• 93.8% primary/secondary patency at 30 days

Negative

• Boxed Warning: graft failure can cause life‑threatening hemorrhage
• Anastomotic failure observed within 36 days in trials
• Adverse reactions ≥10%: thrombosis, fever, pain
• Manufacturing uses donor-derived cells with transmission risk (no infections reported)

Insights

Clinical Vascular Specialist

Publication reports strong real‑world wartime outcomes for Symvess with sustained patency and zero limb loss, infection, or deaths through follow‑up.

Humacyte deployed Symvess as an off‑the‑shelf acellular tissue engineered vessel for urgent extremity arterial repair, avoiding autologous vein harvest and saving operative time. The study followed 17 combat‑injured patients and reports a 30‑day primary and secondary patency of 93.8% and a sustained patency of 87.1% at up to 18 months, with zero amputations, infections, or deaths.

The findings support the device’s practical mechanism in time‑critical, contaminated wounds, but the release appropriately discloses serious safety constraints: a boxed warning for graft rupture and documented risks of anastomotic failure and thrombosis requiring antiplatelet therapy. These risks materially affect real‑world use and require careful perioperative monitoring and adherence to antiplatelet regimens.

Watch for broader sample sizes, reproducibility in other settings, and formal postmarket surveillance results over the next 12–24 months; regulatory or clinical uptake signals and any reports addressing graft rupture or anastomotic failures are the highest‑impact follow‑ups. The reported metrics provide actionable, short‑ to mid‑term evidence but derive from a small series of 17 patients, so validation in larger cohorts remains the critical next milestone.

- Results published in Oxford Academic’s Military Medicine Journal -

- After up to 18 months of follow-up patients were observed to have zero infections, amputations or deaths and a high rate of patency -

DURHAM, N.C., Oct. 06, 2025 (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 in Oxford Academic’s Military Medicine of positive long-term results from its humanitarian program using Symvess to treat wartime vascular trauma injuries in Ukraine. The publication, titled "Evaluating the Safety and Efficacy of Humacyte Acellular Tissue-Engineered Vessel in a Real-World Combat Setting: A Retrospective Observational Multicenter Study,” reported that trauma patients with wartime injuries treated with Symvess were observed to have a continued high rate of patency (87.1%), 100% limb salvage, and zero cases of conduit infection in 17 patients with extremity injuries followed for up to 18 months.

“War is changing, and our military medicine needs to keep pace,” said Oleksandr Sokolov, M.D., Ph.D., a Ukrainian vascular surgeon who treated patients with Symvess under the humanitarian program. “With the growing scale and complexity of missile- and drone-related trauma, prolonged delays and infection risk amplify the medical challenge, exposing critical gaps in timely treatment and long-term recovery. Immediate availability of a biologic conduit enables faster reconstruction and offers a practical alternative even when autologous vein is not feasible. Long-term outcomes reinforce my conclusion from using Symvess: Biologic conduits hold strong potential to advance vascular trauma care by shortening reconstruction time, reducing acute ischemia duration, lowering complication rates, and improving limb salvage.”

Battlefield vascular injuries are some of the most difficult for surgeons to treat because of time pressure and the potential for infection. Unlike traditional autologous vein grafts, which require harvesting a patient’s vein during surgery, Symvess (acellular tissue engineered vessel (ATEV™)) is designed to be immediately available off-the-shelf — saving critical surgical time in wartime situations. Symvess has also showed low rates of infection.

The publication described the outcomes of 17 patients treated with treated with Symvess whose injuries included combat-related extremity vascular trauma from gunshots, blasts, and shrapnel. At 30 days of follow up, the primary measurement point in the study, patients treated with Symvess had incurred zero deaths, zero amputations, and zero cases of infection. The 30-day primary and secondary patency rate was 93.8%. The long-term results published for the first time in Military Medicine confirmed these earlier positive outcomes. At up to 18 months of follow up, patients were observed to have suffered zero deaths, zero infections, and zero amputations. Furthermore, Symvess demonstrated continued high levels of patency (87.1%) and no instances of immunological rejection.

“These outcomes not only validate the strong results we saw at the 30-day mark, but also demonstrate that patients can sustain these benefits over time, even when sustaining devastating combat wounds,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Humacyte’s goal has always been to improve outcomes and reduce complications for patients, and we know that goes far beyond immediate follow up. Our soldiers — and surgeons — deserve the cutting-edge in patient care, and we are excited to be offering them a new option.”

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, 2024 and Form 10-Q for the quarter ended March 31, 2025, 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

What long-term results did Humacyte (HUMA) publish for Symvess on Oct 6, 2025?

The publication reported in 17 Ukrainian wartime patients up to 18 months follow-up: 87.1% patency, 100% limb salvage, and zero infections, amputations, or deaths.

What was Symvess 30-day performance reported in the study for HUMA?

At 30 days the study reported a 93.8% primary and secondary patency rate with zero deaths, amputations, or infections.

What is the approved indication for Symvess (HUMA)?

Symvess is indicated as an off‑the‑shelf vascular conduit for adult extremity arterial injury when urgent revascularization is needed and autologous vein is not feasible.

What safety warnings should investors note about Symvess (HUMA)?

Symvess includes a Boxed Warning for graft failure causing life‑threatening hemorrhage, risk of thrombosis, and anastomotic failure observed within 36 days.

Did the study report any immunologic rejection or transmissible infections for Symvess?

The study reported no immunologic rejection and no transmissible‑agent infections were reported during clinical testing.

How many patients were included in the published Humacyte (HUMA) humanitarian study?

The retrospective multicenter study described outcomes for 17 patients with combat-related extremity vascular injuries.