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Smith+Nephew Launches REGENETEN Bioinductive Implant in Japan

bioinductive-implant-launch

Smith+Nephew announces the launch of its REGENETEN Bioinductive Implant allowing access to thousands of patients in Japan. With more than 100,000 procedures completed globally since its introduction in the US and Europe, REGENETEN has had a transformative impact on the way surgeons approach rotator cuff repair.

The biocompatible and purified collagen-based REGENETEN Bioinductive Implant induces new tendon-like growth by taking advantage of natural wound healing processes 1-7 which can help create an environment conducive to healing1-3,5,6,8-13. Delivered arthroscopically through a small incision over the location of the damaged rotator cuff, the implant is about the size of a postage stamp and is completely resorbed within six months2,9*

With more than 18 published clinical studies conducted globally6,8-10,13-20, the REGENETEN Bioinductive Implant arrives in Japan with extensive clinical evidence covering the entire spectrum of rotator cuff disease, from partial thickness tears to large (3-5cm) and massive (5cm+) full-thickness tears6. Additionally, with the potential to aid approximately 14,000 annual rotator cuff procedures in Japan21, REGENETEN provides a patient-centric treatment shown to change the course of tear progression3-5,11, aid return to normal activity11, and reduce re-tears versus conventional surgery by up to 86%10,22-23.

“Smith+Nephew’s REGENETEN is a first-in-class bioinductive implant technology in Japan. With the most clinical publications in its category, we are very excited to have this new bioinductive solution to aid treatment for thousands of patients across Japan with rotator cuff tears”, said Shinya Dobashi, Senior Vice President and Managing Director, North Asia, Smith+Nephew.

The REGENETEN Bioinductive Implant is part of Smith+Nephew’s comprehensive Advanced Healing Solutions portfolio – redefining biological healing in rotator cuff repair. To learn more about the REGENETEN Bioinductive Implant, please click here.

*Composed of type I collagen

  1. Smith & Nephew. Internal report: REGENETEN Collagen Implant Physical Characteristics. 2020;
  2. Van Kampen C, et al. Muscles Ligaments Tendons J. 2013;3(3):229-35.
  3. Bokor D, et al. Muscles Ligaments Tendons J. 2019;9(3):338-47;
  4. Bokor DJ, et al. Muscles Ligaments Tendons J. 2016;6(1):16-25;
  5. Schlegel TF, et al. J Shoulder Elbow Surg. 2018;27(2):242-51;
  6. Thon SG et al. Am J Sports Med. 2019;47(8):1901-8.
  7. McElvany MD, et al. Am J Sports Med. 2015;43(2):491-500.
  8. Bokor DJ, et al. Muscles, Ligaments Tendons J. 2016;6(1):16-25;
  9. Arnoczky SP, et al. Arthroscopy. 2017;33(2):278-83;
  10. Bokor DJ et al. Muscles Ligaments Tendons J. 2015;5(3):144-50;
  11. McIntyre LF, et al. Arthroscopy. 2019;35(8):2262-71;
  12. Material and Structural Testing Core, Mayo Clinic 2019. Internal Report. EO/SPM/REGENTEN/001/V1.
  13. McIntyre LF, McMillan S, Trenhaile SW, Bishai SK, Bushnell BD. Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry. Arthrosc Sports Med Rehabil. 2021 Aug 20;3(5):e1473-e1479
  14. Bushnell BD, Connor P, Harris HW, Ho CP, Trenhaile SW, Abrams JS. Two-year outcomes with a bioinductive collagen implant used in augmentation of arthroscopic repair of full-thickness rotator cuff tears: Final results of a prospective multi-center study. J Shoulder Elbow Surg. 2022 Jul 1:S1058-2746
  15. Micheloni GM, Salmaso G, Zecchinato G, Giaretta S, Barison E, Momoli A. Bio-inductive implant for rotator cuff repair: our experience and technical notes. Acta Biomed. 2020 Dec 30;91(14-S)
  16. Camacho-Chacon JA, Cuenca-Espierrez J, Roda-Rojo V, Martin-Martinez A, Calderon-Meza JM, Alvarez-Alegret R, Martin-Hernandez C. Bioinductive collagen implants facilitate tendon regeneration in rotator cuff tears. J Exp Orthop. 2022 Jun 8;9(1):53
  17. Bushnell BD, Bishai SK, Krupp RJ, McMillan S, Schofield BA, Trenhaile SW, McIntyre LF. Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry. Orthop J Sports Med. 2021 Aug 13;9(8
  18. Dai A, Campbell A, Bloom D, Baron S, Begly J, Meislin R. Collagen-Based Bioinductive Implant for Treatment of Partial Thickness Rotator Cuff Tears. Bull Hosp Jt Dis (2013). 2020 Sep;78(3):195-201
  19. Schlegel TF, Abrams JS, Angelo RL, Getelman MH, Ho CP, Bushnell BD. Isolated bioinductive repair of partial-thickness rotator cuff tears using a resorbable bovine collagen implant: two-year radiologic and clinical outcomes from a prospective multicenter study. J Shoulder Elbow Surg. 2021 Aug;30(8):1938-1948
  20. Yeazell S, Lutz A, Bohon H, Shanley E, Thigpen CA, Kissenberth MJ, Pill SG. Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. J Shoulder Elbow Surg. 2022 Jun;31(6S):S131-S135
  21. DRG 2021 report. Smith + Nephew analysis of market size and addressable tears.
  22. Smith + Nephew 2019. An overview of the outcomes associated with the standard of care for the surgical treatment of rotator cuff tears. Internal Report EO/SPM/REGENETEN/005/v1.
  23. Ruiz Iban MA, Navlet MG, Marco SM, et al. The Effect on healing rate of the addition of a bioinductive implant to a rotator cuff repair. Preliminary report presented at: The European Society for Surgery of the Shoulder and Elbow (SECEC) Annual Congress; September 7–9, 2022; Dublin, Ireland.

Source: Smith+Nephew

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