TELA Bio® Announces New Data on Use of OviTex in a Range of Hernia Repair Applications, Including Novel ReBAR (Reinforced Biologic Augmented Repair) Technique
Positive results presented at the 2021 Society of American Gastrointestinal and Endoscopic Surgeons Meeting show advancement in hernia repair options
MALVERN, Pa., Sept. 13, 2021 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: 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 details of the clinical research presented last week at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting in Las Vegas, Nevada.
Two poster presentations revealed new data, while a third video presentation demonstrated a novel surgical technique that leverages the unique properties of OviTex® Reinforced Tissue Matrix.
Robotic Assisted ReBAR of 111 Inguinal Hernias, presented by Dr. Cory Banaschak, DO and Dr. Paul Szotek, MD, MBA, FACS, Medical Director of the Indiana Hernia Center, revealed a 2.7% recurrence rate, a 1.8% surgical site occurrence rate, and no infections in patients with at least one year of follow-up. The authors concluded that robotic transabdominal preperitoneal (rTAPP) inguinal hernia repair with OviTex presents a viable and more natural repair alternative in minimally invasive surgery, an approach typically reserved for permanent synthetic meshes. Dr. Szotek stated, "The Reinforced Biologic Augmented Repair, or the ReBAR technique, applies sound hernia surgery principles while leveraging the benefits of a reinforced biologic material with a low synthetic foreign body burden. Our initial goals in adopting OviTex were to lower recurrences while decreasing the amount of synthetic foreign body implanted. That's what patients are increasingly looking for, and it makes a lot of clinical sense if you can achieve it. With over five years of experience utilizing the ReBAR technique with OviTex, it appears that we are on the way to achieving these goals."
Additional data on hernia repairs performed by Drs. Szotek and Banaschak employing the ReBAR technique was recently highlighted in an article entitled, Minimizing Retained Foreign Body in Hernia Repair Using a Novel Technique: Reinforced Biologic Augmented Repair (ReBAR) published in the Journal of Clinical and Medical Research. In this prospective study of 619 implants using the ReBAR technique for a variety of open and minimally invasive inguinal and abdominal hernia repairs the authors reported an overall recurrence rate of 1.3%.
Use of Ovine Reinforced Tissue Matrix in Bridged Incisional Hernia Repair, presented by Dr. DeNoto III, MD, FACS, Director of General Surgery at St. Francis Hospital in New York, analyzed recurrence rates in the treatment of abdominal hernias that require reinforcement in the absence of a primary repair. "These are some of the most complex and challenging patients to reduce the potential of a future hernia recurrence," said Dr. DeNoto. In this series, patients with bridged repairs using OviTex had a 14% recurrence rate. "To put the results of our study in perspective, at similar time points we have seen recurrence rates more than double when repaired with human or porcine mesh products. This is a major reason why patients presenting with bridged repairs are so difficult to treat and why an effective reinforcement option is much needed."
For more information on the SAGES poster presentations, visit https://epostersonline.com/sages2021/
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 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 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 and the development of new variants of COVID-19, such as the delta variant, including but not limited to 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, our ability to enhance our product offerings, that data from studies related to our products may not be replicated in later studies or indicative of future data, development and manufacturing problems, capacity constraints or delays in production of our products, maintenance of coverage and adequate reimbursement for procedures using our products, 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.