24-Month BRAVO study results showed a 2.6% recurrence rate in diverse clinical scenarios
Robotic Reinforced Biologic Augmented Repair (ReBAR) study showed a 1.9% recurrence rate at two-year mark
MALVERN, Pa., Aug. 04, 2022 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today 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.
24-Month results of the BRAVO Study: A prospective, multi-center study evaluating the clinical outcomes of ventral hernias treated with OviTex 1S Permanent Reinforced Tissue Matrix
AHS presentation on Friday, September 16th, 10:20-10:30 a.m.ET
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.
These BRAVO 24-Month results follow the publication of the BRAVO 12-Month study, released in November 2021 in the Journal of Clinical Medicine.
Robotic Reinforced Biologic Augmented Repair (ReBAR) of Over 150 Inguinal Hernias: 2-Year Outcomes
AHS presentation on Wednesday, September 14th, 11:20-11:30 a.m.ET
This retrospective study examined the two-year recurrence rate of the robotic-assisted reinforced biologic augmented repair (ReBAR) of inguinal hernias from June 2018 to April 2022. All repairs employed the standard robotic transabdominal preperitoneal (rTAPP) approach combined with the novel ReBAR technique, which consists of suture closure of the defect followed by a biologic mesh reinforcement. After two years, only three recurrences were identified from the 157 inguinal hernias repaired using the ReBAR technique - a rate of 1.9%, and only two SSOs were identified in this cohort.
“We are proud to share these positive clinical results for both our BRAVO patient population and those who underwent a ReBAR repair. We believe this research demonstrates that we’re succeeding in our mission to provide an effective portfolio of tissue reinforcement solutions while minimizing the permanent synthetic polymer footprint,” stated Antony Koblish, President and CEO of TELA Bio. "Today’s patients are eager for a repair solution that is more natural and contains less permanent foreign bodies. These results show that OviTex not only meets these criteria but also contributes to increasing patient quality of life.”
About TELA Bio, Inc.
TELA Bio, Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient's own anatomy. The Company is committed to providing surgeons with advanced, economically effective soft-tissue reconstruction solutions that leverage the patient's natural healing response while minimizing long-term exposure to permanent synthetic materials. For more information, visit www.telabio.com.
About OviTex
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 Tissue Matrix 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 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, 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, data obtained from clinical studies using our product may not be indicative of outcomes in other surgical settings, and 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.
Investor Contact
Greg Chodaczek
347-620-7010
ir@telabio.com
Media Contact
Alyson Kuritz
908-892-7149
alyson@0to5.com
