Humacyte, Inc. released the 36‑month follow‑up results for its Symvess acellular tissue‑engineered vessel in the Journal of Vascular Surgery Cases, Innovations and Techniques. The study, which followed 54 patients who received Symvess when autologous vein was not an option, reports a 92.9% infection‑free rate from months 3 to 36 and limb‑salvage rates of 87.3% at 12 months and 82.5% at 24 months.
The data also show that five patients (9%) underwent amputation of the treated limb within the first 30 days and eight patients (15%) had an amputation by the end of the 36‑month period. No graft ruptures or mechanical failures were observed, and there were no deaths attributable to Symvess. The study’s adverse event profile includes graft thrombosis, pyrexia, and pain, all of which were managed without long‑term sequelae.
These results confirm the durability and safety of Symvess in a high‑risk, contaminated trauma population, but the small sample size and the severity of the injuries limit the generalizability of the findings. The study’s population was largely composed of patients with extensive tissue loss and infection, which may inflate complication rates relative to a broader clinical setting.
Commercially, Symvess was launched in February 2025 and by August 2025 had received value‑analysis committee approval at 82 civilian hospitals. The product is priced at $29,500 per unit, and Humacyte has submitted a New Technology Add‑On Payment application to CMS that could provide additional reimbursement starting October 1, 2025. In Q2 2025, the company generated $0.3 million in revenue, with $0.1 million attributable to U.S. Symvess sales, reflecting early market penetration but modest volume.
Financially, Humacyte continues to operate at negative margins and a low Altman Z‑Score, underscoring ongoing liquidity challenges. The company announced a $77.5 million credit facility in December 2025 to support working capital and product development, but the debt burden remains a headwind to profitability. The long‑term data, while encouraging for clinical adoption, do not yet translate into significant revenue growth.
Dr. Laura Niklason, CEO of Humacyte, said the 36‑month data “demonstrate that an off‑the‑shelf conduit can perform safely and with durability in the most challenging trauma cases, reinforcing our commitment to expanding access to this life‑saving technology.”
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