TELA Bio, Inc. announced that two studies examining clinical outcomes with use of its OviTex Reinforced Tissue Matrix will be presented at the 2022 American Hernia Society (AHS) Meeting. The conference, taking place from September 14-16, 2022, in Charlotte, North Carolina, will highlight the outcomes of two studies that underscore the efficacy of OviTex. TELA Bio's prospective, single-arm, multi-center clinical trial was designed to evaluate the clinical performance of OviTex 1S with permanent polymer embroidery for primary or recurrent ventral hernias in 92 enrolled patients.

OviTex 1S Permanent demonstrated a 2.6% recurrence rate in ventral hernias repaired using open, laparoscopic, or robotic techniques at the 24-month time point. Surgical site occurrences (SSOs) were observed in 38% of the study population, where 78% of all enrolled patients were characterized as high risk for experiencing an SSO based on at least one known risk factor. These risk factors included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (=75 years).

This study included diverse clinical scenarios for ventral hernias as OviTex 1S was utilized in open and minimally invasive procedures, various planes of placement, and CDC wound classes I-III. The use of OviTex 1S in BRAVO patients also resulted in clinically meaningful improvements in their quality of life and perceived health. Improvements were reported as early as 90 days after surgery and this improvement persisted over the 24 months of follow-up.