TELA Bio, Inc., a commercial-stage medical technology company, focuses on providing soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s anatomy. The company provides a portfolio of OviTex Reinforced Tissue Matrix (OviTex) products for hernia repair and abdominal wall reconstruction; and OviTex PRS Reinforced Tissue Matrix products to address the unmet needs in plastic and reconstructive surgery, as well as OviTex for Laparoscopic and Robotic Procedures, a sterile reinforced tissue matrix derived from ovine rumen with polypropylene fiber intended to be used in laparoscopic and robotic-assisted hernia surgical repairs. It markets its products through a single direct sales force, principally in the United States. The company was incorporated in 2012 and is headquartered in Malvern, Pennsylvania.
TELA Bio Announces 510(k) Clearance for Liora™ Monofilament Scaffold for Soft Tissue Reinforcement
TELA Bio received FDA 510(k) clearance for its Liora Monofilament Scaffold, a fully resorbable surgical mesh for soft tissue reinforcement.
Liora is the first implant fully developed in the company's ISO 8 certified cleanroom in Malvern, PA, and expands its soft tissue reconstruction portfolio.
Additional launch details are expected on the Q3 earnings call in early November.