Smith+Nephew unveils major clinical evidence and patient access updates for its REGENETEN™ Bioinductive Implant

Smith+Nephew ((LSE:SN, NYSE:SNN), the global medical technology company, today announces new evidence and market updates that highlight the clinical performance of its REGENETEN Bioinductive Implant and support its further adoption. Substantial investment into research to expand access and indications have led to these important results designed to help surgeons treat more patients who suffer from 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 orthopaedic diagnostic, treatment, and postoperative procedures
• Analyzing RCTs for bioinductive implants, AAOS have 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 1-year results which have already made a significant impact in supporting patient access and adoption.³

Extra-articular Ligaments

For the first time, Smith+Nephew is able to market the REGENETEN Bioinductive* Implant for extra-articular ligament injuries in the US.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 each year.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 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 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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Media Enquiries

Dave Snyder                +1 (978) 749-1440

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* 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.

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 $5.8 billion in 2024. 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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