TELA Bio Highlights Published Clinical Research from 2022 Showcasing Safety and Performance of Reinforced Biologic for Hernia Indications
Recent research of OviTex® Reinforced Tissue Matrix demonstrated favorable results in various hernia and abdominal wall reconstruction applications
MALVERN, Pa., March 16, 2023 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today highlights six studies published in 2022. The data across these studies demonstrate favorable outcomes with the use of OviTex Reinforced Tissue Matrix that support its use as a better alternative to traditional synthetic and biologic mesh products.
It is estimated that over two million hernia repairs will be performed this year within the United States, Europe, and the United Kingdom. Of critical importance to surgeons and patients is the incorporation of a hernia reinforcement material that will help limit the potential for complications such as infection and hernia recurrence.
Launched in June 2016, OviTex has been rigorously studied in the clinical setting since its commercialization. Recently, two European and four US published clinical studies demonstrated favorable outcomes with the use of OviTex Reinforced Tissue Matrix.1–6 These publications evaluated a total of 280 OviTex patients in both prospective and retrospective studies across a range of patient characteristics, procedural approaches, and planes of placement, including bridged repair. Three studies directly compared OviTex to pure biologics or permanent synthetics, with favorable results for OviTex. These favorable outcomes included lower complication rates and lower recurrence rates for OviTex in comparison to pure biologics1,5, as well as lower surgical site occurrences and similar recurrence rates for OviTex in comparison to permanent synthetics6.
“We are pleased to showcase these six studies,” said Marissa Conrad, Vice President of Clinical Affairs. “As hernia patients become more educated about their treatment options, it’s important they are aware of published research demonstrating that effective, more natural materials are available for their repair.”
- Sivaraj, D.; Henn, D.; Fischer, K. S.; Kim, T. S.; Black, C. K.; Lin, J. Q.; Barrera, J. A.; Leeolou, M. C.; Makarewicz, N. S.; Chen, K.; Perrault, D. P.; Gurtner, G. C.; Lee, G. K.; Nazerali, R.* Reinforced Biologic Mesh Reduces Postoperative Complications Compared to Biologic Mesh after Ventral Hernia Repair. Plastic Reconstr Surg - Global Open 2022, 10 (2), e4083. DOI: 10.1097/GOX.0000000000004083
- G., 3rd DeNoto.* Bridged Repair of Large Ventral Hernia Defects Using an Ovine Reinforced Biologic: A Case Series. Ann Medicine Surg 2022, 75, 103446. DOI: 10.1016/j.amsu.2022.103446
- Timmer, A. S.; Claessen, J. J. M.; Koning, I. M. B. de; Haenen, S. M.; Belt, E. J. T.; Bastiaansen, A.; Verdaasdonk, E. G. G.; Wolffenbuttel, C. P.; Schreurs, W. H.; Draaisma, W. A.; Boermeester, M. A.* Clinical Outcomes of Open Abdominal Wall Reconstruction with the Use of a Polypropylene Reinforced Tissue Matrix: A Multicenter Retrospective Study. Hernia 2022, 26 (5), 1241–1250. DOI: 10.1007/s10029-022-02604-y
- DeNoto, G.; Ceppa, E. P.; Pacella, S. J.; Sawyer, M.; Slayden, G.; Takata, M.; Tuma, G.; Yunis, J.* 24-Month Results of the BRAVO Study: A Prospective, Multi-Center Study Evaluating the Clinical Outcomes of a Ventral Hernia Cohort Treated with OviTex® 1S Permanent Reinforced Tissue Matrix. Ann Medicine Surg 2022, 83, 104745. DOI: 10.1016/j.amsu.2022.104745
- Goetz, M.; Jurczyk, M.; Junger, H. J.; Brunner, S. M.; Brennfleck, F. W.* Semiresorbable biologic hybrid meshes for ventral abdominal hernia repair in potentially contaminated settings: lower risk of recurrence. Updates Surg. 2022 Dec;74(6):1995-2001. DOI: 10.1007/s13304-022-01378-3
- Sivaraj, D.; Fischer, K. S.; Kim, T. S.; Chen, K.; Tigchelaar, S. S.; Trotsyuk, A. A.; Gurtner, G. C.; Lee, G. K.; Henn, D.; Nazerali, R. S.* Outcomes of Biosynthetic and Synthetic Mesh in Ventral Hernia Repair. Plastic Reconstr Surg - Global Open 2022, 10 (12), e4707. DOI: 10.1097/GOX.0000000000004707
*Indicates one or more surgeons are paid consultants of TELA Bio, Inc.
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. The following adverse events have been reported for surgical repair of hernias (with or without the use of surgical mesh): pain, infection, hernia recurrence, adhesion, bowel obstruction, bleeding, fistula, seroma, perforation, mesh migration, and mesh contraction. For additional important safety information, please see the OviTex Instructions for Use at www.telabio.com/ovitex.html.
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.
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, that data obtained from clinical studies using our product may not be indicative of outcomes in other surgical settings, and other 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.