Symvess Commercial Growth
Symvess sales grew to $0.5M in Q1 2026 from $0.1M in Q1 2025 (+400%), with units rising to 29 from 5 (+480%). Management reported sequential unit growth and expanding usage across ~30+ sites with evidence of colleague adoption beyond initial index surgeons.
Dialysis Phase III (V012) Progress and Near-Term Milestone
V012 enrollment reached 120 patients; prespecified interim topline results are expected for presentation by June 11, 2026 (Vascular Annual Meeting). If positive, the trial will stop per protocol and Humacyte plans a supplemental BLA submission for dialysis in H2 2026.
CTEV (Coronary Tissue Engineered Vessel) Advancement
IND for CTEV was submitted in late 2025, first large-scale manufacturing lot is nearing completion in the commercial facility, and a Phase I/II CABG trial is planned to commence in H2 2026. Vessels are 3.5 mm diameter, tailored for coronary use.
Commercial Leadership Strengthening
Company added senior commercial and clinical leaders to accelerate launch: James Mercadante as Chief Commercial Officer and Dr. Todd Rasmussen as Chief Surgical Officer, plus expanded field commercial talent focused on IDNs and surgeon education.
International and Strategic Engagements
Submitted MAA for Israel which was accepted for review (180 working-day review); announced $1.475M purchase commitment from the Kingdom of Saudi Arabia to support clinical evaluation and outreach; received dedicated U.S. Department of Defense funding for evaluation and incorporation of biologic vascular repair technologies; regained ex-U.S. rights enabling outreach to Middle East, Europe and Japan.
Restructuring, Cost Savings and Cash Position
Implemented workforce reduction of 45 employees (~25%) to focus resources on commercialization; estimated one-time severance and termination benefits of ~$0.8M (mostly Q2 2026) and projected net savings of ~$14.3M for remainder of 2026. Cash, cash equivalents and restricted cash were $48.9M as of March 31, 2026; net cash used of $2.0M in Q1 2026.