Tela Bio said today that its partner Aroa Biosurgery won CE Mark approval in the European Union for its OviTex Reinforced BioScaffold, which Tela Bio will commercially launch in the region.
Malvern, Penn.-based Tela Bio said that is has offered the OviTex RBS for ventral hernia repairs and abdominal wall reconstruction procedures in the US since July 2016.
The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Tela Bio said. The company touted that more than 2,000 procedures have been performed with the OviTex RBSs to date.
“Securing EC Certification will provide the opportunity for patients with complex hernia in Europe to gain access to the advantages of OviTex RBSs. We are pleased that Tela Bio can now build on their growing success in the United States and begin a commercial rollout in Europe,” Aroa Biosurgery CEO Brian Ward said in a press release.
Results from a retrospective study of the OviTex RBSs, presented at the Americas Hernia Society International Hernia Congress 2018, showed that use of the devices led to a low recurrence rate and a low complication rate. Tela Bio said it has launched a post-market clinical study of the scaffolds to continue evaluation their safety and efficacy.
“We are excited to announce that our strategic partner has received a CE Mark for OviTex RBSs and look forward to bringing the benefits of this innovative solution to the European market. Historically, biologic products have had limited success in Europe due to their high price points, but our unique supply chain enables us to deliver OviTex RBSs at a significant cost reduction that is well-suited for the healthcare landscape overseas,” Tela Bio prez & CEO Antony Koblish said in a prepared statement.
In March, Tela Bio said that it landed a $1 million investment from ProMedica, a not-for-profit healthcare group serving northwest Ohio and southern Michigan.