regulatory
confidence high
sentiment positive
materiality 0.65
TELA Bio receives FDA 510(k) clearance for OviTex PRS Long-Term Resorbable
TELA Bio, Inc.
- FDA granted 510(k) clearance on March 23, 2023 for OviTex PRS Long-Term Resorbable.
- Product reinforces soft tissue in plastic and reconstructive surgery where weakness exists.
- Complements existing OviTex PRS Permanent and Short-Term Resorbable configurations.
- Design features bi-directional stretch and a fully resorbable long-term polymer.
- CEO Antony Koblish states it expands clinical utility and demonstrates tunable design capabilities.