Clinical Evidence Updates Released for REGENETEN Bioinductive Implant

Smith+Nephew is sharing new evidence and market updates that highlight the clinical performance of its REGENETEN Bioinductive Implant, which treats rotator cuff tears and other tendon and extra-articular ligament injuries throughout the body:

AAOS Clinical Practice Guideline (CPG) on the Management of Rotator Cuff Injuries¹
For the first time, recent updates to the American Academy of Orthopaedic Surgeons (AAOS) CPG on the Management of Rotator Cuff Injuries highlight the value of bioinductive implants in rotator cuff repair, based on independent analysis of studies:

• AAOS CPGs provide evidence-based recommendations for current orthopedic diagnostic, treatment, and postoperative procedures
• Analyzing RCTs for bioinductive implants, AAOS issued a strong recommendation that, “The use of bioinductive tendon implants to augment rotator cuff repair, or as an alternative to standard repair, can lead to lower re-tear rates and better patient reported outcomes.”

Randomized Controlled Trial (RCT) Results²
Two-year results of the MALLAMANGUITO RCT from Dr. Miguel A. Ruiz Ibán and colleagues demonstrated a sustained 65% relative reduction in re-tear rates when using the REGENETEN Bioinductive Implant to augment repair of full-thickness rotator cuff tears:²

• Two-year re-tear rates were 12.3% (7/57) with the REGENETEN Implant vs. 35.1% (20/57) with standard repair (p=0.004).
• These results build on previously reported one-year results that have already made a significant impact in supporting patient access and adoption.³

Extra-Articular Ligaments
For the first time, Smith+Nephew is marketing the REGENETEN Bioinductive* Implant for extra-articular ligament injuries in the United States.⁴ This new indication expansion offers opportunities to reach more patients with soft tissue injuries throughout the body. It will initially focus on hip capsule repair with abundant opportunities for future expansions in other extra-articular ligament repairs.

With more than 150,000 procedures⁵ completed globally since its introduction in 2014, the REGENETEN Bioinductive Implant has had a transformative impact, offering a better solution for the more than 1 million people having tendon or extra-articular ligament repair annually.⁶ The collagen-based implant supports the body’s natural healing response to facilitate the formation of new tissue to biologically augment repairs and support natural healing processes.^7-11

“These significant updates for the REGENETEN Implant are the culmination of many years of hard work from both the Smith+Nephew team and surgeon community,” said Scott Schaffner, president of Global Sports Medicine at Smith+Nephew. “We are excited about its future potential to treat even more patients who require surgical repair of soft tissue injuries every year.”

The REGENETEN Bioinductive Implant is part of Smith+Nephew’s Advanced Healing Solutions portfolio.

Smith+Nephew is a portfolio medical technology business focused on repairing, regenerating, and replacing soft and hard tissue. Its 17,000 employees make a difference to patients’ lives through the company’s product portfolio, and the invention and application of new technologies across three global business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management. Founded in Hull, U.K., in 1856, Smith+Nephew operates in around 100 countries, and generated $5.8 billion in 2024 sales. Smith+Nephew is a constituent of the FTSE100.

* Bioinductivity has been demonstrated only in tendon tissue

References
1 American Academy of Orthopedic Surgeons (AAOS). Rotator Cuff Repair Clinical Practice Guideline. Available at: https://www.aaos.org/quality/quality-programs/rotator-cuff/. [Accessed August 2025].
2 Ruiz Iban MA, et al. Arthroscopy. Apr 08 2025 [ePub Ahead of Print].
3 Ruiz Iban MA, et al. Arthroscopy. 2024;40(6):P1760-1773.
4 iData Research. Rotator Cuff Global Incidence, 2024.
5 Smith+Nephew. Internal Data.
6 FDA. 510(k) Premarket Notification: K242631 [Accessed May 2025]
7 Bokor DJ, Sonnabend D, Deady L, et al. Evidence ofhealing of partial-thickness rotator cuff tears following arthroscopicaugmentation with a collagen implant: a 2-year MRI follow-up. Muscles,Ligaments Tendons J 2016;6(1):16-25.
8 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.
9 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.
10 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.
11 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.
12 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.