TELA Bio, Inc., a surgical reconstruction company leading the development and commercialization of OviTex Reinforced BioScaffolds (RBSs) for soft tissue repair, today declared that its partner Aroa Biosurgery, a soft-tissue repair company based in New Zealand that develops and manufactures medical products to increase healing, has been granted EC Certification (CE Mark) allowing for the commercial launch of OviTex RBSs in the European Union (EU).
"We are excited to declare that our strategic partner has received a CE Mark for OviTex RBSs and look forward to bringing the benefits of this inventive solution to the European market," said Antony Koblish, president and CEO of TELA Bio. "Historically, biologic products have had limited success in Europe due to their high price points, but our unique supply chain allows us to deliver OviTex RBSs at a significant cost reduction that is well-suited for the healthcare landscape overseas."
"Securing EC Certification will provide the opportunity for patients with complex hernia in Europe to gain access to the advantages of OviTex RBSs," said Brian Ward, CEO of Aroa Biosurgery. "We are pleased that TELA Bio can now build on their growing success in the United States and begin a commercial rollout in Europe."
TELA Bio first commercialized OviTex RBSs in the U.S. for ventral hernia repairs and abdominal wall reconstruction procedures in July 2016. They are a distinct class of surgical implants that integrate biologic and synthetic materials in a uniquely embroidered construction that permits movement of fluid and cells through the construct. The biologic material, derived from ovine rumen, permits for functional tissue remodeling, while the polymer provides additional strength and developed handling.
More than 2000 implantations with OviTex RBSs have been completed to date in a wide range of hernia procedures using a variety of surgical techniques. Data from a retrospective study presented at the Americas Hernia Society International Hernia Congress 2018 showed the use of OviTex RBSs in abdominal wall reconstruction procedures led to low recurrence and complication rates.i TELA Bio has initiated a post-market clinical study, BioScaffold Reconstruction of Abdominal wall and Ventral hernia defects with Open or laparoscopic repair (BRAVO), to further estimate the safety and efficacy of OviTex RBSs.