Tela Bio said today it initiated a post-market clinical study of its OviTex reinforced bioscaffold designed for soft tissue repair, enrolling the 1st patient at La Jolla, Calif.’s Scripps Clinic.
The Ovitex reinforced bioscaffolds are designed for hernia repair or abdominal wall reconstructions, Tela Bio said. The scaffolds are designed with either permanent polymer or resorbable polymers, and are a mix of biologic and synthetic materials.
“We are committed to providing surgeons with the advanced soft tissue repair materials they need, and that means we must continue to innovate and tailor OviTex products based on real-world experience. Surgeon feedback on OviTex performance and surgical handling has been positive so far, and we are excited to initiate a formal clinical data collection program that will support future efforts to refine surgical mesh design and develop new clinical protocols for hernia repair,” Tela Bio chief medical officer Dr. Maarten Persenaire said in a press release.
In the Bravo study, Malvern, Penn.-based company will explore the use of the OviTex in 100 ventral hernia patients, monitoring the incidence of early post-operative surgical site occurrences, wound-related events and other complications within 3 months of surgery.
Study researchers will follow up at 90 days, 12 months and 24-months, recording the incidence of true hernia recurrence, surgical site occurrences and other complications occurring more than 3 months post-surgery. Patient quality of life and pain assessments will also be recorded, the company said.
“Many of the biologic materials available today have the flexibility I need, but lack consistent long-term durability that is required for success in soft tissue reconstruction. OviTex RBSs are an exciting advance because they feature the benefits of both polymer and biologic materials, strength and safety in one. I applaud this young company for taking the right approach to post-market research,” principal investigator Dr. George DeNoto III of New York’s St. Francis Hospital said in a prepared statement.
“We are pleased to be the first clinical site to enroll a patient in the post-market study. OviTex RBSs are a promising new technology for hernia repair and we look forward to learning more about how this mesh design can impact the lives of our patients,” Dr. Salvatore Pacella of La Jolla, Calif.’s Scripps Green Hospital said in a prepared release.
In January, Tela Bio raised $7.4 million in a new round of equity financing, with money coming from 16 unnamed investors, according to an SEC filing.