TELA Bio , a Malvern, Pennsylvania-based commercial-stage medical technology company focused on soft tissue reconstruction, announced on October 5, 2026 that the U.S. Food and Drug Administration has granted 510(k) clearance for its Liora™ Monofilament Scaffold.
“FDA 510(k) clearance is a significant milestone for TELA Bio as Liora is the first fully resorbable synthetic product in our portfolio to be designed and produced in-house by our team of innovative engineers,” said Heather Getz, CEO of TELA Bio. “The addition of Liora to our portfolio expands the options available to surgeons and patients for their soft tissue reconstruction needs.”
Designed and Built in Malvern
Liora is a fully resorbable surgical mesh for soft tissue reinforcement. It is the first implant fully developed in TELA Bio’s ISO 8-certified cleanroom in Malvern, and the company says it will help TELA Bio expand its footprint in the soft tissue reconstruction market. TELA Bio plans to share more details on Liora during its third-quarter earnings call, expected in early November.
About TELA Bio
TELA Bio is a commercial-stage medical technology company developing soft tissue reconstruction solutions that prioritize preserving and restoring the patient’s own anatomy. Its products are designed to work with the body’s natural healing response while minimizing long-term exposure to permanent synthetic materials.
