Results from the first-ever randomized control trial for the REGENETEN Implant in partial-thickness rotator cuff repair

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces compelling new randomized control trial (RCT) data confirming significant outcome improvements for patients with partial-thickness rotator cuff tears treated with the 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,**
• Moderate-intensity household chores: 3.8 vs 8.4 weeks (p<0.001)1,**    
   

The study, recently published in the Orthopaedic Journal of Sports Medicine, also concluded that REGENETEN Implant patients enjoyed a better quality of life at 6 weeks and 3 months, and high rates of tendon healing at 1 year, comparable to suture anchor-based repairs.1 This is the third RCT demonstrating that the REGENETEN Bioinductive Implant improves outcomes versus 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 introduction in 2014, the REGENETEN Bioinductive Implant has had a transformative impact, offering a better solution for thousands of patients with rotator cuff injuries every year.9 The collagen-based implant supports the body’s natural healing response to facilitate the formation of 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 comprehensive Advanced Healing Solutions portfolio – redefining biological healing in rotator cuff repair. To learn more about the REGENETEN Bioinductive Implant, please click here.

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Dave Snyder                +1 (978) 749-1440
Smith+Nephew            david.snyder@smith-nephew.com

* 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.

About Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 17,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Founded in Hull, UK, in 1856, we now operate in around 100 countries, and generated annual sales of $6.2 billion in 2025. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.

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