Humacyte Announces Presentation of Symvess® Long-Term Safety and Efficacy Results at VESS Meeting
Rhea-AI Summary
Humacyte (Nasdaq: HUMA) presented 36-month V005 trial results for Symvess at the VESS Annual Winter Meeting on Feb 18, 2026. Symvess showed 92.9% infection-free rate from months 3–36, 87.3% limb salvage at 12 months and durable vessel diameter with no dilatation or narrowing through 36 months.
No conduit-related deaths or spontaneous structural failures were reported; three conduit infections occurred overall.
Positive
- Infection-free rate of 92.9% from months 3–36
- Limb salvage 87.3% at 12 months
- Limb salvage 82.5% at 24 months
- No dilatation or narrowing of mid-graft diameter through 36 months
- No conduit-related deaths or spontaneous structural failures reported
Negative
- Boxed warning: risk of life-threatening graft failure from rupture
- Anastomotic failure observed within first 36 days in trials
- Thrombosis risk reported; antiplatelet therapy recommended
- Transmission risk from donor-derived materials despite testing safeguards
- Common adverse reactions include graft thrombosis, fever, and pain
News Market Reaction – HUMA
In the Feb 18 session, HUMA declined 5.26%, reflecting a notable negative market reaction. Argus tracked a peak move of +6.2% during that session. Argus tracked a trough of -2.9% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 09 | DoD funding news | Positive | +30.0% | Targeted FY2026 U.S. DoD funding for Symvess procurement and evaluation. |
| Jan 08 | Health economics data | Positive | -2.5% | Five-year hospital charge analysis highlighting high costs of complications and Symvess benefits. |
| Jan 05 | Israel MAA plan | Positive | +8.7% | Plan to file Israel MAA for Symvess with 120 working‑day review expectation. |
| Dec 22 | V005 results publication | Positive | -3.6% | Journal publication of three‑year V005 Phase 2/3 Symvess extremity trauma outcomes. |
| Dec 16 | Credit facility | Neutral | -5.1% | Credit facility up to $77.5M with initial $40M tranche to refinance debt and fund growth. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent Symvess-focused positive news has produced mixed follow‑through, with some strong gains but also selloffs on favorable trial and publication updates.
Over the last few months, Humacyte has highlighted Symvess across funding, clinical, and market-access milestones. On Dec 16, 2025, it secured a credit facility up to $77.5 million, followed by publication of three-year V005 data on Dec 22, 2025. In early January 2026, it announced an Israel MAA plan and economic data on extremity arterial injuries. On Feb 9, 2026, new U.S. Department of Defense funding underscored military interest in Symvess. Today’s VESS presentation reiterates the same long-term safety and durability profile in trauma repair.
Key Terms
acellular tissue engineered vessel medical
limb salvage medical
duplex ultrasound medical
graft failure medical
anastomotic failure medical
thrombosis medical
antiplatelet therapy medical
vascular conduit medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Data presented at Annual Winter Meeting 2026 for the Vascular & Endovascular Surgery Society -
- After up to 36 months of follow-up, extremity arterial trauma patients had high rates of limb salvage, low rates of infection, and no unprovoked structural failures -
- Long-term durability results showed no dilatation nor narrowing of Symvess diameter out to 36 months -
DURHAM, N.C., Feb. 18, 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 long-term data assessing the durability of Symvess in extremity arterial trauma patients at the Annual Winter Meeting 2026 for the Vascular & Endovascular Surgery Society (VESS) in Olympic Valley, CA.
The presentation, titled “Long-Term Outcomes of the Acellular Tissue Engineered Vessel in Extremity Arterial Trauma Repair: Results from the V005 Trial,” was delivered by Michael Curi, MD, MPA, Chief, Division of Vascular Surgery, Vice Chair, Department of Surgery, Assoc Prof of Surgery, Rutgers – New Jersey Medical School. In the V005 trial, Symvess maintained long-term structural integrity, exhibited low infection rates, and supported high rates of limb salvage in patients who were followed for up to 36 months.
"These long-term results demonstrate the potential of Symvess to meet the needs of trauma patients when autologous vein is not available or feasible," said Dr. Curi. "During the V005 study, there were sustained low rates of infection, no conduit related deaths, and excellent Symvess durability out to three years—outcomes that translate into meaningful benefits for patients facing life or limb threatening injuries where autologous reconstruction is not an option."
Among those treated in the V005 Phase 2/3 study were 54 patients who underwent extremity vascular repair with Symvess for whom treatment with autologous vein, the standard of care, was not feasible. Within this patient population, once early complications from the traumatic injuries resolved, the rates of conduit infection, limb salvage, and patient survival plateaued and remained relatively constant through the three years of follow-up. Symvess maintained an infection-free rate of
Long-term mechanical durability was also demonstrated during the V005 study. Duplex ultrasound was used to evaluate patency and mid-vessel diameter at each follow-up visit through month 36. Average mid-graft vessel diameter did not materially depart from the baseline of 6mm over 36 months. In addition, there was no evidence of trends in either dilatation or narrowing for Symvess diameter out to 36 months. Adverse events and serious adverse events declined over time, supporting the long-term durability of this vascular repair. Importantly, no deaths, amputations, or mechanical failures were attributed to Symvess. Also, there was no evidence of spontaneous ruptures or structural failures in any patient throughout the follow-up period.
Vascular wounds are challenging for surgeons to treat, and autologous vein grafts have traditionally served as the standard of care due to their durability and low infection rates. However, autologous grafts are not always feasible in injury settings where veins are damaged or there is little time to harvest. Symvess (acellular tissue engineered vessel (ATEV)) is designed to be immediately available off-the-shelf — saving critical surgical time in emergency situations — and has also consistently demonstrated low rates of infection.
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 ≥
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 September 30, 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
