TELA Bio, Inc. (NASDAQ: TELA) announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its Liora Monofilament Scaffold, a fully resorbable surgical mesh device intended for soft tissue reinforcement.

According to the company, Liora is the first product to be fully developed in TELA Bio's ISO 8 certified cleanroom in Malvern, Pa., and the first fully resorbable synthetic product in its portfolio to be designed and produced in-house.

"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."

The company said it will provide additional details on the product during its third quarter earnings call, expected to be held in early November.