TELA Bio Announces Commercial Launch of OviTex™ Reinforced BioScaffolds for Ventral Hernia Repair and Abdominal Wall Reconstruction
MALVERN, Pa., July 13, 2016 /PRNewswire/ — TELA Bio, Inc., a surgical reconstruction company leading the development of Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced the commercial launch of the company’s OviTex™ portfolio of products for use in ventral hernia repair and abdominal wall reconstruction following U.S. Food and Drug Administration (FDA) 510(K) clearance. 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.
“We are committed to collaborating closely with leading surgeons to reinvigorate the soft tissue reconstruction implant market and bring high performance, cost-effective solutions to hospitals, surgeons and patients,” said Antony Koblish, president and CEO of TELA Bio. “Surgeons have been telling us that integrating polymer and biologic materials represented a necessary evolution in hernia repair that minimizes the amount of foreign material left behind and provides the promise of a durable repair. We have developed an extensive pre-clinical research data set to support our products. These data have consistently demonstrated important performance advantages over commercially available biologic and synthetic materials.”
In the U.S. there are about 350,000 ventral hernia repairs performed each year, representing a common but often challenging procedure for general and plastic reconstructive surgeons. In an effort to improve long-term recurrence rates, surgical meshes are often used to reinforce soft tissue. Currently available options for soft tissue reinforcement include biologic materials that provide a scaffold for cellular repopulation and remodel into a patient’s tissue, or synthetic materials that are less prone to laxity issues seen with some biologics. However, neither option is ideal. Clinical results with biologics are mixed over time, proving increasingly unacceptable given their high cost. Long-term presence of synthetics in patients has been shown to pose risks due to a sustained inflammatory response, and they also have been shown to complicate future abdominal surgeries, which many of these patients undergo. TELA Bio seeks to fill a product innovation void in the market by purposefully designing implants that integrate polymer and biologic materials, harnessing their benefits and mitigating their pitfalls.
“Without an ideal surgical mesh implant, over the last decade many surgeons have focused on learning novel hernia repair techniques to accommodate for older technology implants,” said Dr. Stephen Ferzoco, a Boston-based hernia surgeon. “The reinforced technology in the OviTex portfolio combines the strength advantages of synthetics with a natural biologic material, offering the best of both worlds and helping surgeons achieve successful patient outcomes without the need to learn new techniques.”
The OviTex portfolio includes six products with a range of sizes, thicknesses, and degrees of reinforcement that allows surgeons to 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. The FDA granted 510(K) clearance for the resorbable polymer products in March 2016 and recently granted the same clearance for permanent polymer products in June 2016. TELA Bio is poised to enroll post-market clinical studies following initial commercialization.
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 BioScaffolds (RBSs) 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. TELA Bio plans to launch OviTex in North America and the European Union, and 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.
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