Disclaimers and References

† Non human primate data on file. Animal test results may not necessarily be indicative of clinical performance.

*TELA Bio sales data. | **Data on File

Important Safety Information: OviTex Reinforced Tissue Matrix Permanent 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. OviTex Reinforced Tissue Matrix Long-Term Resorbable 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 materials. OviTex Inguinal is indicated for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of inguinal hernias that require the use of reinforcing material to obtain the desired surgical outcomes. Caution: Federal (US) law restricts this device to sale by or on order of a physician. Do not use OviTex in patients known to be sensitive to materials of ovine (sheep) origin. Use of OviTex in this patient population may result in an allergic or immunological reaction. The following adverse events have been reported for surgical repair of hernias (with or without the use of surgical mesh): pain, infection, dysphagia, 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. Healthcare professionals must use their own clinical judgment in evaluating appropriate treatment options for a particular patient. Treatment of a specific patient should be based on individual needs and the medical care deemed necessary by the patient’s treating physician. 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. Please contact your TELA Bio representative if you have questions about TELA Bio products Individual markets. Please contact your TELA Bio representative if you have questions about TELA Bio products. † Non human primate data on file. Animal test results may not necessarily be indicative of clinical performance. References: 1. Overbeck, N.; Nagvajara, G.M.; Ferzoco, S.; May, B.C.H.; Beierschmitt, A.; Qi, S. In-vivo evaluation of a reinforced ovine biologic: A comparative study to available hernia mesh repair materials. Hernia 2020, 24, 1293–1306. 2. Lun S, Irvine S.M., Johnson K.D., Fisher N.J., Floden E.W., Negron L., Dempsey S.G., McLaughlin R.J., Vasudevamurthy M., Ward B.R., May B.C., A functional extracellular matrix biomaterial derived from ovine forestomach, Biomaterials 31(16) (2010) 4517-29. 3. Irvine, S. M.; Cayzer, J.; Todd, E. M.; Lun, S.; Floden, E. W.; Negron, L.; Fisher, J. N.; Dempsey, S. G.; Alexander, A.; Hill, M.C.; O’Rouke, A.; Gunningham, S. P.; Knight, C.; Davis, P. F.; Ward, B.R.; May, B. C. H. Quantification of in vitro and in vivo angiogenesis stimulated by ovine forestomach matrix biomaterial. Biomaterials 2011, 32 (27), 6351−61. 4. Dempsey SG, Miller CH, Hill RC, Hansen KC, May BCH. Functional Insights from the Proteomic Inventory of Ovine Forestomach Matrix. J Proteome Res. 2019 Apr 5;18(4):1657-1668. doi: 10.1021/acs.jproteome.8b00908. Epub 2019 Mar 25. PMID: 30879303. 5. Fernandez, Luis. Definitive ClosureUsing an Ovine Reinforced Tissue Matrix in the Complex Open Abdomen after Penetrating Thoraco-Abdominal Trauma. Poster Presented at: Abdominal Wall Reconstruction Conference; June 8-11, 2022; Virtual. 6. Goetz, M., Jurczyk, M., Junger, H., Schlitt, H. J., Brunner, S. M., & Brennfleck, F. W. (2022). Semiresorbable biologic hybrid meshes for ventral abdominal hernia repair in potentially contaminated settings: lower risk of recurrence. Updates in surgery, 74(6), 1995–2001. https://doi.org/10.1007/s13304-022-01378-3 7. Ankney C, Banaschak C, Sowers B, Szotek P. Minimizing Retained Foreign Body in Hernia Repair Using a Novel Technique: Reinforced Biologic Augmented Repair (ReBAR). J Clin Med Res. 2021;3(4):1-11. https://doi.org/10.37191/ Mapsci-2582-4333-3(4)-073 8. 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. (2022).Outcomes of Biosynthetic and Synthetic Mesh in Ventral Hernia Repair. Plastic and reconstructive surgery. Global open, 10(12), e4707. https://doi.org/10.1097/GOX.0000000000004707 9. Parker, M. J., Kim, R. C., Barrio, M., Socas, J., Reed, L. R., Nakeeb, A., House, M. G., & Ceppa, E. P. (2021). A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highestrisk patients. Surgical endoscopy, 35(9), 5173–5178. https://doi.org/10.1007/s00464-020-08009-1 10. DeNoto, G., III, Ceppa, E. P., Pacella, S. J., Sawyer, M., Slayden, G., Takata, M., Tuma, G., & Yunis, J. (2022). 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. Annals of Medicine and Surgery, 2022, 104745, ISSN 2049-0801. https://doi.org/10.1016/j.amsu.2022.104745 11. 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. (2022). Reinforced Biologic Mesh Reduces Postoperative Complications Compared to Biologic Mesh after Ventral Hernia Repair. Plastic and reconstructive surgery. Global open, 10(2), e4083. https://doi.org/10.1097/GOX.0000000000004083 12. Sawyer M. (2018). New Ovine Polymer-Reinforced Bioscaffold in Hiatal Hernia Repair. JSLS : Journal of the Society of Laparoendoscopic Surgeons, 22(4), e2018.00057. https://doi.org/10.4293/JSLS.2018.00057 13. DeNoto, G., III (2022). Bridged repair of large ventral hernia defects using an ovine reinforced biologic: A case series. Annals of medicine and surgery (2012), 75, 103446. https://doi. org/10.1016/j.amsu.2022.103446 14. Ferzoco, S. (2018). Early Experience Outcome of a Reinforced Bioscaffold in Inguinal Hernia Repair: A Case Series. International Journal of Surgery Open, 12. 9-11. https://doi.org/10.1016/j.ijso.2018.06.001 15. Ankney C, Banaschak C, Sowers B, Szotek P (2021) Minimizing Retained Foreign Body in Hernia Repair Using a Novel Technique: Reinforced Biologic Augmented Repair (ReBAR). Maples. 2021 July 16. Al-Qudimat AR, Altahtamouni SB, Singh K, Aboumarzouk OM, Elakkad M. Clinical Outcome of OviTex Reinforced Tissue Matrix in Hernia Repair: A Systematic Review and Meta-Analysis, Qatar Medical Journal 2025(1):22 https://doi.org/10.5339/2025.22 17. McCranie AS, Blades C, Dawson S, Foppiani J, Allenby T, Winocour J, Cohen J, Mathes DW, Kaoutzanis C. Abdominal Wall Reinforcement Using OviTex after Deep Inferior Epigastric Perforator Flap. J Reconstr Microsurg. 2025 Mar 11. doi: 10.1055/a2555-2348. Epub ahead of print. PMID: 40068894. 18. Abed M, Bradley A, Ghazanfar A. Use of OviTex 1S, Reinforced Tissue Matrix, For the Repair of Post Renal Transplant Incisional Hernias: Four Case Reports. World J Clin Cases 2025; 13(18): 99749 [DOI: 10.12998/wjcc.v13.i18.99749] 19. Sweitzer K, O’Shea A, Tawil C, Weissberg J, Tomtschik J, Butterfield J, Fowler C, Langstein H, Bell D. Hernia Recurrence and Complications After Abdominal Reconstruction With Reinforced Versus Nonreinforced Biologic Mesh. Ann Plast Surg. 2024 Apr 1;92(4S Suppl 2):S196-S199. doi: 10.1097/SAP.0000000000003875. PMID: 38556672 20. Lake SP, Deeken CR, Agarwal AK. Reinforced Tissue Matrix to Strengthen the Abdominal Wall Following Reversal of Temporary Ostomies or to Treat Incisional Hernias. World Journal of Gastrointestinal Surgery. 2024 Mar;16(3):823-832. DOI: 10.4240/wjgs.v16.i3.823. PMID: 38577081; PMCID: PMC10989334 21. Bloemendaal ALA. Robotic Retromuscular (Recurrent) Parastomal Hernia Repair (r-Pauli-Repair) With Synthetically Reinforced Biological Mesh; Technique, Early Experience, and Short-Term Follow-Up. J Abdom Wall Surg. 2023 Dec 13;2:12059. doi: 10.3389/jaws.2023.12059. PMID: 38312416; PMCID: PMC10831679 22. Kim TS, Sivaraj D, Lakhlani D, Johnstone T, Szotek P, Henn D, Nazerali RS. Ventral Hernia Repair With Onlay Placement of Biosynthetic Ovine Rumen Is Noninferior to Retrorectus Placement. Plast Reconstr Surg Glob Open. 2025 Apr 2;13(4):e6666. doi: 10.1097/ GOX.0000000000006666. PMID: 40182300; PMCID: PMC11964383 23. Anthony N. Dardano DO, FACS, Iakov Efimenko, MD , Taylor Florio, MD , Monali Mahedia, MD and Andrew M. Klapper, MD. Rapid Revascularization Following Application of Ovine Forestomach Matrix Graft in Complex Facial and Scalp Trauma. Trauma Cases Rev 2024, 10:105 24. Dempsey SG, Miller CH, Schueler J, Veale RWF, Day DJ, May BCH (2020) A novel chemotactic factor derived from the extracellular matrix protein decorin recruits mesenchymal stromal cells in vitro and in vivo. PLoS ONE 15(7): e0235784. https://doi.org/10.1371/journal. pone.0235784 25. Smith, M. J., S. G. Dempsey, R. W. Veale, C. G. Duston-Fursman, C. A. F. Rayner, C. Javanapong, D. Gerneke, S. G. Dowling, B. A. Bosque, T. Karnik, M. J. Jerram, A. Nagarajan, R. Rajam, A. Jowsey, S. Cutajar, I. Mason, R. G. Stanley, A. Campbell, J. Malmstrom, C. H. Miller and B. C. H. May (2021). “Further structural characterization of ovine forestomach matrix and multi-layered extracellular matrix composites for soft tissue repair.” J Biomater Appl 36(6): 996-1010. 26. Negron, L., S. Lun and B. C. H. May (2012). ‘Ovine forestomach matrix biomaterial is a broad spectrum inhibitor of matrix metalloproteinases and neutrophil elastase.’ Int Wound J 11(4): 392–39