TELA Bio Announces 12-Month Analysis from BRAVO Study of OviTex® for Ventral Hernia Repair
MALVERN, Pa., March 18, 2021 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("TELA"), a commercial-stage medical technology company focused on designing, developing, and marketing innovative tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today announced the results of the 12-month analysis from the company's post-market BRAVO study evaluating the clinical performance of OviTex Reinforced Tissue Matrix for the treatment of ventral hernias. The data have been submitted to a medical journal for publication and demonstrate minimal postoperative surgical complications and hernia recurrence rates at 12-months with interim results up to 24-months.
"These results continue to be outstanding and compare very favorably to results published for synthetics, resorbable synthetics, or biologics," said Antony Koblish, President and CEO of TELA Bio. "We look forward to the completion of the BRAVO trial later this year and the presentation of our full two-year dataset, which we believe will demonstrate the clinical benefits of OviTex for use in the treatment of ventral hernias."
The analysis includes the full patient cohort at the 12-month follow-up and an interim cohort at the 24-month follow-up. The final 12-month analysis includes 76 patients, of whom two patients experienced a recurrence, both adjacent to the original repair, with the OviTex repairs remaining intact. Fifty-one (51) patients reached the 24-month follow-up, with none experiencing a recurrence.
"The data from the BRAVO study continues to demonstrate that Ovitex is an excellent choice for the treatment of ventral hernias," said Principal Investigator Dr. George DeNoto III, MD, FACS, Director of General Surgery at St. Francis Hospital in New York. "We are encouraged by the results of the complete data set of the BRAVO study that reveal the long-term outcomes and durability surgeons are seeking when choosing a material to use in hernia repair."
About TELA Bio, Inc.
TELA Bio Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on designing, developing, and marketing innovative tissue reinforcement materials to address unmet needs in soft tissue reconstruction. The company is committed to providing patients with advanced, economically effective biologic material repair solutions to patients to minimize long-term exposure to permanent synthetic materials and improve clinical outcomes. TELA Bio's OviTex® and OviTex PRS Reinforced Tissue Matrix products are purposefully designed to address the shortcomings of existing reinforcement materials in hernia repair, abdominal wall reconstruction and plastic and reconstructive surgery. For more information, visit www.telabio.com.
OviTex Reinforced Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome. Do not use OviTex in patients known to be sensitive to materials of ovine (sheep) origin. For prescription use only. For additional important safety information, please see the OviTex Reinforced BioScaffold Instructions for Use.
The statements made or results achieved by TELA Bio customers described herein were achieved in their specific setting. Due to variations in clinical experience and technique, there is no guarantee that these results are typical. A surgeon must use his or her own clinical judgment when deciding which products are appropriate for the treatment of a particular patient. Always refer to the package insert, product label, and/or instructions for use before using any TELA Bio product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of TELA's management. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others, the impact to our business of the ongoing COVID-19 pandemic, including any impact on our ability to market our products, demand for our products due to deferral of procedures using our products or disruption in our supply chain, our ability to achieve or sustain profitability, our ability to gain market acceptance for our products and to accurately forecast and meet customer demand, our ability to compete successfully, that data from earlier studies related to our products and interim data from ongoing studies may not be replicated in later studies or indicative of future data, our ability to enhance our product offerings, development and manufacturing problems, capacity constraints or delays in production of our products, maintenance of coverage and adequate reimbursement for procedures using our products, product defects or failures. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and TELA assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.
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