MALVERN, PA — TELA Bio Inc. (NASDAQ: TELA) has received U.S. Food and Drug Administration clearance for a fully resorbable surgical mesh developed and manufactured at its Malvern facility, expanding the medical technology company’s soft-tissue reconstruction portfolio and establishing a new internally produced product line.
The FDA granted 510(k) clearance for the Liora Monofilament Scaffold, a synthetic implant designed to reinforce soft tissue during surgical procedures, TELA Bio disclosed October 5.
Liora is the company’s first fully resorbable synthetic product designed and produced in-house, marking an expansion of its manufacturing capabilities beyond its existing portfolio.
The device was developed at TELA Bio’s ISO 8-certified cleanroom in Malvern, where the company conducts controlled-environment manufacturing operations.
FDA 510(k) clearance permits a medical device to be marketed after the agency determines it is substantially equivalent to a legally marketed predicate device. The pathway differs from the FDA’s premarket approval process.
The clearance gives TELA Bio an additional product category in the soft-tissue reconstruction market, where surgical meshes are used to provide structural reinforcement during tissue repair.
“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,” Chief Executive Officer Heather Getz said.
“The addition of Liora to our portfolio expands the options available to surgeons and patients for their soft tissue reconstruction needs.”
The development also reflects TELA Bio’s investment in internal product engineering and manufacturing, with Liora representing the first implant fully developed in its Malvern cleanroom.
The company plans to provide additional information about the product during its third-quarter earnings conference call, expected in early November.
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