Smith+Nephew Shares Positive Study Data for its REGENETEN Bioinductive Implant

New trial results are showing significant improvements in outcomes for partial-thickness rotator cuff tear patients treated with Smith+Nephew’s REGENETEN Bioinductive Implant in isolation.^1,*

Compared with a traditional suture anchor repair, early recovery time was halved¹ for patients returning to daily activities such as:

• Driving: 2.3 vs 5.1 weeks (p<0.001)^1,**
• Office work: 1.7 vs 3.6 weeks (p=0.009)^1,**
• Return to moderate-intensity household chores: 3.8 vs 8.4 weeks (p<0.001)^1,**

The randomized controlled study, recently published in the Orthopaedic Journal of Sports Medicine, also found that REGENETEN Implant patients experienced better quality of life at six weeks and three months and high tendon healing rates at one year, comparable to suture anchor-based repairs.¹ This is the third study to demonstrate the REGENETEN Bioinductive Implant improves outcomes compared with traditional rotator cuff repair techniques.^2-7

“We conducted a randomised controlled study of patients with symptomatic partial-thickness rotator cuff tears and found that those patients treated with the tendon sparing REGENETEN Bioinductive Implant recovered functional independence much faster than patients treated with standard surgery,” said Dr. Allan Wang, clinical professor of Orthopedic Surgery at the University of Western Australia. “Time to sling removal, return to driving, office duties, and household tasks all occurred sooner with the REGENETEN Bioinductive Implant. Importantly, these milestones were achieved without an increase in patients’ pain and without compromise in rotator cuff tendon healing on 12-month MRI scans. This study marks an important shift in the evolving standard of care for partial-thickness rotator cuff tears.”

With more than 250,000 procedures⁸ completed globally since its 2014 introduction, the REGENETEN Bioinductive Implant has offered a better solution for patients with rotator cuff injuries every year.⁹ The collagen-based implant supports the body’s natural healing response to form new tissue to biologically augment repairs.^2-5, 10

This evidence follows the recent revision to the American Academy of Orthopaedic Surgeons Clinical Practice Guideline on the “Management of Rotator Cuff Injuries,” which highlights the value of bioinductive implants in rotator cuff repair based on an independent analysis of studies.

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

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration, and replacement of soft and hard tissue. Its 17,000 employees strive to make a difference to patients’ lives through 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 more than 100 countries and generated $5.8 billion in 2024 sales. Smith+Nephew is a constituent of the FTSE100.

* Compared with standard arthroscopic rotator cuff repair.

** Rehabilitation protocols differed between treatment groups: isolated REGENETEN Bioinductive Implant use employed a faster post-op rehab protocol vs traditional repair.

References
¹ Wang A, et al. Orthop J Sports Med. 2026;14(3):23259671261418675.
² Bokor DJ, et al. Muscles, Ligaments Tendons J 2016;6(1):16-25.
³ Bokor DJ, et al. Muscles, Ligaments Tendons J 2019;9(3):338-347.
⁴ Ruiz Iban MA, et al. Arthroscopy. 2025;41(10):3869-3879.
⁵ Ruiz Iban MA, et al. Arthroscopy. 2024;40(6):P1760-1773.
⁶ 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].
⁷ Camacho Chacón et al. J Shoulder Elbow Surg. 2024;33(9):1894-1904.
⁸ Smith+Nephew. Internal Data.
⁹ FDA. 510(k) Premarket Notification: K242631 [Accessed May 2025]
¹⁰ Arnoczky SP, et al. Arthroscopy. 2017;33(2):278-283.