regulatory
confidence high
sentiment positive
materiality 0.80
Vericel gets FDA approval for NexoBrid to treat severe thermal burns in adults
Vericel Corp
- FDA approved NexoBrid (anacaulase-bcdb) for eschar removal in adults with deep partial- and full-thickness thermal burns.
- Approval based on Phase 3 DETECT study meeting primary endpoint of complete eschar removal vs placebo.
- NexoBrid showed shorter time to eschar removal and lower incidence of surgical removal vs standard of care.
- Commercial launch expected in Q2 2023; company plans to establish it as new standard of care.
- Expands Vericel's target addressable market beyond sports medicine into severe burn care.