FDA Grants TELA Bio Clearance of OviTex PRS Long-Term Resorbable


MALVERN, PATELA Bio, Inc. (NASDAQ: TELA) announced that the U.S. Food and Drug Administration recently granted 510(k) clearance for the Company’s OviTex PRS Long-Term Resorbable product. OviTex PRS Long-Term Resorbable is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

OviTex PRS Long-Term Resorbable complements the Company’s existing OviTex PRS portfolio, which includes OviTex PRS Permanent and OviTex PRS Short-Term Resorbable configurations. The OviTex PRS portfolio consists of products with two or three layers of high-quality tissue derived from ovine rumen, which is reinforced with either permanent or resorbable polymer for added strength, stabilization, and controlled stretch. These products are designed to improve outcomes by facilitating functional tissue remodeling while controlling the degree and direction of stretch. OviTex PRS Long-Term Resorbable enhances the OviTex PRS portfolio with specific design features including bi-directional stretch and a fully resorbable, long-term polymer for reinforcement.

“The OviTex PRS portfolio is integral to our mission to deliver next-generation soft-tissue repair solutions that offer clinical effectiveness and economic benefits,” said Antony Koblish, President and CEO of TELA Bio. “This new offering expands the clinical utility of the OviTex PRS portfolio and demonstrates our ability to leverage the tunable design of OviTex PRS to meet the varying needs of surgeons and patients in plastic and reconstructive surgery.”

To learn more, please www.ovitexprs.com.

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