regulatory
confidence high
sentiment positive
materiality 0.55
TELA Bio wins FDA 510(k) clearance for Liora fully resorbable surgical mesh
TELA Bio, Inc.
- FDA granted 510(k) clearance for Liora Monofilament Scaffold, a fully resorbable synthetic surgical mesh for soft tissue reinforcement.
- Liora is the first implant fully developed in TELA Bio's ISO 8 certified cleanroom in Malvern, PA, and the first fully resorbable synthetic product in its portfolio.
- CEO Heather Getz called the clearance 'a significant milestone' that expands options for surgeons and patients in soft tissue reconstruction.
- Company says Liora expands its footprint in the soft tissue reconstruction market; more details to come on the Q3 earnings call expected in early November.