Smith+Nephew Launches REGENETEN◊ Bioinductive Implant in India

Smith+Nephew has announced the launch of its REGENETEN Bioinductive Implant in India. With more than 100,000 procedures completed globally since its introduction, the REGENETEN implant has had a transformative impact on the way surgeons approach rotator cuff procedures.

The collagen-based REGENETEN Bioinductive Implant supports the body’s natural healing response to facilitate the growth of new tendon-like tissue^1-3,6 to biologically augment the existing tendon and change the course of disease progression.1-5 Delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury, the implant is about the size of a postage stamp and by 6 months, the implant is no longer visible, with new tendon-like tissue and oriented collagen suggestive of functional loading.^*7

The REGENETEN Bioinductive Implant arrives in India with more than 10 years of clinically demonstrated results in 18 studies covering the entire spectrum of rotator cuff disease, from partial thickness tears² to large (3-5cm) and massive (5cm+) full-thickness tears.⁶ Most recently, new data from a triple-blinded randomized controlled trial has shown that the addition of the REGENETEN Bioinductive Implant to a conventional rotator cuff repair delivers a relative reduction of 86% in re-tear rates at 12 months vs. conventional surgery alone.⁸

The prevalence of rotator cuff disease in India was estimated to be 150,000 in 2022 with approximately 28,000 patients undergoing rotator cuff repair procedures. The total rotator cuff repair market in India is expected to reach 33,000 cases in 2023 and 39,000 in 2024, with year-over-year growth of 15%.⁹

“We are beyond excited to bring the REGENETEN Bioinductive Implant to India and advance the standard of care for patients suffering from rotator cuff disease,” commented Joaquin Lasso, Managing Director, South Asia for Smith+Nephew. “The clinical evidence speaks for itself – REGENETEN Bioinductive Implant is changing the game in rotator cuff repair and generating positive outcomes for thousands of patients all over the world.”

The REGENETEN Bioinductive Implant is part of Smith+Nephew’s comprehensive Advanced Healing Solutions portfolio – redefining biological healing in rotator cuff repair.

^◊ Trademark of Smith+Nephew. Certain marks registered US Patent and Trademark Office.

1. Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J 2016;6(1):16-25.
2. Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2018 27(2):242-251.
3. Van Kampen C, Arnoczky S, Parks P, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: a histological evaluation in sheep. Muscles Ligaments Tendons J. 2013;3(3):229-235.
4. Bokor DJ, Sonnabend DH, Deady L, et al. Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up. Muscles, Ligaments Tendons J 2019;9(3):338-347.
5. McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA, 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491-500.
6. Thon SG, O’Malley L, O’Brien MJ, Savoie FH. Evaluation of Healing Rates and Safety With a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes. Am J Sports Med 2019;47(8):1901-1908.
7. Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283
8. Ruiz Iban MA, García Navlet M, Moros Marco S, et al. The Effect On Healing Rate Of The Addition Of A Bioinductive Implant To A Rotator Cuff Repair. Preliminary Report. SECEC. 2022.
9. Smith+Nephew, Internal Market Procedure Data

Source: Smith+Nephew