MALVERN, PA — TELA Bio, Inc. (NASDAQ: TELA) announced the recent publication of the 12-month analysis from the BRAVO Study in the Journal of Clinical Medicine.
TELA Bio’s prospective, single arm, multicenter, post market BRAVO study was designed to evaluate the clinical performance of OviTex 1S with permanent polymer for primary or recurrent ventral hernias. A total of 75 patients were evaluated at 12 months, with only two (2.7%) patients demonstrating hernia recurrence adjacent to the original repair, leaving the primary hernia repair and OviTex intact. The 12-month analysis also showed low surgical site occurrence and surgical site infection rates. Twenty-four-month follow-up has been completed with overall hernia recurrence rates remaining below 5%. Final analysis is underway, and the 24-month BRAVO study results will be presented in a future peer-reviewed publication.
“On behalf of the entire investigator team, we are pleased to see the 12-month clinical data of the BRAVO study in publication. These 12-month results are quite encouraging and appear to be staying steady in our 24-month assessments. These results are all the more promising as our hernia recurrence rates are low and 79% of our BRAVO patient population at 12 months presented with one or more comorbidities known to increase risk of complications in hernia repair,” said principal investigator, Dr. George DeNoto III, MD, FACS, Director of General Surgery at St. Francis Hospital in New York. “With more and more patients expressing reservations about traditional hernia mesh to their doctors, it’s critical that newer hernia reinforcement materials such as OviTex are rigorously evaluated in the clinical setting.”
In addition to primary surgical outcomes, patient quality of life was also assessed as part of the BRAVO study. The authors reported that all patient-reported assessments showed significant improvement in quality of life at 12 months post-surgery.
“This initial publication of the BRAVO study represents an important checkpoint for TELA Bio’s corporate mission. Since inception, our overarching goal has been to address the very well documented shortcomings of legacy synthetic and biologic hernia mesh. During the design process of OviTex, we incorporated input from over 100 general and plastic surgeons and prior to commercialization conducted what we believe to be the most extensive pre-clinical research of its kind to validate performance,” stated Antony Koblish, President and CEO of TELA Bio. “We believe this published research demonstrates that we’re succeeding in our mission and further supports what we’ve been seeing over the past five years and in nearly 20,000 commercial implantations of our products, of which more than 18,000 were for hernia applications.”
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