MALVERN, PA — TELA Bio, Inc. (“TELA”), a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, announced the results of an interim analysis from the company’s post-market BRAVO study evaluating the clinical performance of OviTex for the treatment of ventral hernias.
The data have been submitted to a medical journal for publication, and show low surgical complication and hernia recurrence rates at various time points up to 24-months postoperatively.
“These results continue to validate the effectiveness of OviTex in improving patient outcomes in ventral hernia repair,” said Antony Koblish, President and CEO of TELA Bio. “We remain confident that additional follow-up data will further establish OviTex as an optimal treatment option to improve patient care and address surgeon needs.”
The interim analysis includes patient cohorts at the 90-day, 12-month and 24-month follow-up periods. At 90 days post-op, there were no recurrences, reoperations, or implant removals among the 85 patients analyzed. At 12 months, 57 patients have been assessed, with only one patient experiencing a recurrence.
Notably, this recurrence occurred in a location adjacent to the original repair in an area of abdominal weakness and the initial repair using OviTex remained intact. Of the 20 patients that have reached 24-month follow-up, none experienced a recurrence or long-term complication.
“We continue to be encouraged by the compelling results from our BRAVO study,” said Principal Investigator Dr. George DeNoto III, MD, FACS, Director of General Surgery at St. Francis Hospital in New York. “The interim results highlight positive patient outcomes with OviTex and the promise of this advanced biologic solution to provide a durable hernia repair as seen by low recurrence rates at 12- and 24-month follow-up with no long-term complications to date.”
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