TELA Bio Announces Settlement of Litigation with LifeCell
TELA Bio to maintain full rights to manufacture and sell its OviTex™ Reinforced BioScaffolds
MALVERN, Pa., Nov. 21, 2016 /PRNewswire/ — TELA Bio, Inc., a surgical reconstruction company leading the development of Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced that it has settled all litigations and disputes between TELA Bio and LifeCell, and that all pending state and federal court actions between the two companies have been dismissed. Terms of the agreement are confidential. The settlement will allow TELA Bio to continue to manufacture and sell its OviTex™ portfolio of products for use in ventral hernia repair and abdominal wall reconstruction, including a hydrated version of OviTex.
“We are very pleased that we were able to achieve a satisfactory resolution to all litigations and disputes between TELA Bio and LifeCell,” said Antony Koblish, president and CEO of TELA Bio, adding, “With this successful action, TELA Bio is now free to focus on our strategy to advance our commercial plan for our portfolio of six OviTex products in an environment of fair competition and further develop our robust product pipeline to expand our offerings for surgeons and patients.”
In July 2016 TELA Bio announced that the U.S. Food and Drug Administration (FDA) granted 510(K) clearance for OviTex RBSs. OviTex RBSs feature an embedded polymer and an intact extracellular matrix (ECM), a biologic building block derived from ovine rumen, in layered constructs designed for multi-directional cell repopulation and healthy tissue remodeling. Thus far, OviTex RBSs have been implanted in more than 150 patients and have been used in the full range of hernia procedures involving open, laparoscopic and robotic surgical techniques.
“TELA Bio is focused on providing innovative cost effective hernia repair implants that support natural healing and durability,” Mr. Koblish added. “Our products are designed to provide surgeons and patients with durable repairs while minimizing the potential for prolonged foreign body reactions often associated with use of currently available polymer-based implants.”
The OviTex portfolio includes six products in a range of sizes, thicknesses, and degrees of reinforcement. Surgeons can choose the appropriate product for each procedure and surgical technique. OviTex RBSs are available with either permanent (polypropylene) polymer or resorbable (polyglycolic acid) polymer reinforcement.
About TELA Bio, Inc.
TELA Bio, Inc. is a privately owned company focused on bringing innovative, cost-effective, surgical reconstruction solutions to surgeons, hospitals and patients. The company’s OviTex™ Reinforced BioScaffold (RBS) products, designed for hernia repair and abdominal wall reconstruction procedures, integrate polymer and biologic materials through engineering design principles. The OviTex portfolio is supported by high-quality, data-driven science and extensive pre-clinical research that has consistently demonstrated the advantages of an RBS over commercially available materials for certain patients and procedures. OviTex is commercially available in the U.S., and TELA Bio plans to launch OviTex in the European Union. The company is collaborating with leading surgeons to drive rapid product development and establish TELA Bio as a leader in surgical reconstruction. To learn more about TELA Bio visit http://www.telabio.com.
Berry & Company Public Relations
SOURCE TELA Bio, Inc.
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