TELA Bio Announces 510(k) Clearance for Liora™ Monofilament Scaffold for Soft Tissue Reinforcement
Globe Newswire•05/10/2026•08:00 ET
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Key Highlights
- ➤FDA grants 510(k) clearance for TELA Bio’s Liora Monofilament Scaffold
- ➤Liora is fully resorbable and designed for soft tissue reinforcement
- ➤Liora is TELA Bio’s first fully resorbable synthetic product developed in-house
- ➤Third-quarter earnings call expected in early November to provide more details
Expert Statements
Heather Getz, CEO of TELA Bio
“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.”
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.”
MALVERN, Pa., Oct. 05, 2026 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (“TELA Bio” or the “Company”), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the Company's Liora Monofilament Scaffold (“Liora”) product.
Liora is a fully resorbable surgical mesh device for soft tissue reinforcement that will enable TELA Bio to expand its footprint in the soft tissue reconstruction market and is the first implant to be fully developed in the Company’s ISO 8 certified cleanroom in Malvern, PA.
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