Humacyte’s Symvess Delivers 87.3% Limb Salvage, 92.9% Infection-Free Rate
In the Phase 2/3 V005 trial of 54 extremity arterial trauma patients treated with Humacyte’s Symvess, limb salvage rates reached 87.3% at 12 months and 82.5% at 24 months during 36-month follow-up. The acellular vessel achieved a 92.9% infection-free rate from month 3–36 with no structural failures or diameter changes.
1. V005 Trial Cohort and Design
In the Phase 2/3 V005 trial, 54 adult extremity arterial trauma patients received Symvess implants when autologous vein reconstruction was not feasible. Patients were monitored for limb salvage, infection incidence and structural integrity through 36 months of follow-up.
2. Limb Salvage and Infection Outcomes
Limb salvage rates were 87.3% at month 12 and 82.5% at month 24, remaining stable through month 36. The graft maintained a 92.9% infection-free rate from month 3 to month 36, with just three conduit infections and no infections occurring after day 37.
3. Structural Durability and Diameter Stability
Duplex ultrasound assessments showed an average mid-graft diameter consistently near 6 mm over three years, with no evidence of vessel dilatation or narrowing. No unprovoked structural failures, ruptures or conduit-related deaths were reported during the trial period.
4. Clinical Application and Safety Profile
Symvess is indicated as an off-the-shelf vascular conduit for urgent extremity arterial repair when autologous veins are unavailable. Its long-term safety profile features low infection and failure rates, though graft rupture and thrombosis risks necessitate antiplatelet therapy and close monitoring for anastomotic complications.