Humacyte (HUMA) investor relations material

Technology overview and clinical progress

• Developed an engineered tissue platform producing implantable human tissues at commercial scale, using human cells seeded on degradable scaffolds, resulting in universally implantable, non-immunogenic blood vessels.

• Over 700 patients treated with no immune rejection; first FDA approval for a 40 cm, 6 mm diameter engineered blood vessel received in late 2024, with market launch in Q1 2025.

• Vertically integrated manufacturing ensures quality and stability; key partnerships include Fresenius Medical Care and the Department of Defense.

Trauma and vascular injury indication

• Symvess, the approved vessel, is off-the-shelf, non-immunogenic, and indicated for urgent revascularization when vein is not available.

• Clinical data from civilian and wartime settings (including Ukraine) showed low infection rates (0.9%), superior patency, and lower amputation rates compared to synthetic grafts.

• Retrospective comparison with vein (gold standard) showed similar outcomes for amputation, infection, and mortality, supporting use when vein is unavailable.

• Economic models indicate lower total hospital costs due to reduced complications, despite higher acquisition cost ($17,000–$20,000).

Hemodialysis access and ongoing studies

• Phase III trial compared the vessel to fistula (gold standard) in 240 patients, showing better function at 6 and 12 months, especially in women and high-risk men.

• V012 trial, the first dialysis study focused solely on women, is nearing interim analysis; positive results could lead to a secondary FDA indication filing in late 2026.

• Vessel maintains diameter in dialysis and PAD settings, with long-term durability and low infection rates.