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

Rhea-AI Summary

Smith+Nephew (NYSE:SNN) has announced significant updates for its REGENETEN Bioinductive Implant, a medical device for treating rotator cuff tears and soft tissue injuries. The American Academy of Orthopaedic Surgeons (AAOS) has issued a strong recommendation for bioinductive implants, highlighting their value in rotator cuff repair.

A key two-year randomized controlled trial demonstrated a 65% relative reduction in re-tear rates when using REGENETEN (12.3% vs 35.1% with standard repair). Additionally, Smith+Nephew has received approval to market the implant for extra-articular ligament injuries in the US, expanding its treatment potential beyond the current 150,000 procedures completed globally since 2014.

Positive

• Strong AAOS recommendation supporting bioinductive implants in rotator cuff repair
• Clinical trial shows 65% reduction in re-tear rates compared to standard repair
• New FDA approval for extra-articular ligament injuries expands market potential
• Successful track record with over 150,000 procedures completed globally since 2014

Negative

• None.

Insights

Medical Device Specialist

REGENETEN implant shows 65% lower re-tear rates, gains AAOS endorsement, and expands to new ligament applications.

The new clinical evidence for Smith+Nephew's REGENETEN Bioinductive Implant represents a significant advancement in soft tissue repair technology. The MALLAMANGUITO randomized controlled trial results are particularly impressive, demonstrating a 65% relative reduction in re-tear rates at two years (12.3% vs. 35.1%, p=0.004) compared to standard repairs. This addresses one of the most persistent challenges in rotator cuff surgery - the durability of repairs.

The American Academy of Orthopaedic Surgeons' Strong Recommendation in their Clinical Practice Guidelines is a pivotal development. AAOS guidelines significantly influence treatment protocols and standard of care in orthopedics. Their statement that bioinductive implants "can lead to lower re-tear rates and better patient reported outcomes" provides independent validation from the field's most respected body.

Perhaps equally important is the expanded indication for extra-articular ligament injuries in the US. This regulatory clearance substantially broadens the potential applications beyond rotator cuff tears to include hip capsule repairs initially, with likely expansion to other ligament repairs. The collagen-based implant's mechanism - facilitating the body's natural healing response to form new tissue - represents a biologically advanced approach compared to purely mechanical solutions.

With 150,000 procedures completed globally since 2014, REGENETEN has moved beyond early adoption to become an established technology with substantial real-world experience. This combination of strong clinical evidence, expanded indications, and regulatory recognitions positions it as an increasingly essential component of the surgical armamentarium for soft tissue injuries.

Healthcare Business Analyst

The clinical and regulatory updates for Smith+Nephew's REGENETEN implant strengthen the company's position in the high-growth sports medicine segment. Three key developments create substantial commercial value:

• The AAOS guideline endorsement typically accelerates both physician adoption and insurance coverage - addressing the two primary market barriers for medical devices
• The two-year clinical data showing 65% reduction in re-tear rates provides compelling differentiation in the competitive rotator cuff market
• The expanded indication for extra-articular ligament repairs significantly increases the addressable market beyond the existing rotator cuff applications

The market opportunity is substantial - while REGENETEN has been used in 150,000 procedures globally since 2014, the press release notes over 1 million annual procedures for tendon or extra-articular ligament repair, suggesting considerable growth potential remains. The hip capsule repair indication provides a natural expansion pathway, allowing Smith+Nephew to leverage the same sales channels while targeting the same orthopedic surgeons who already use the product.

For Smith+Nephew specifically, strengthening their Sports Medicine portfolio is strategically important as this segment typically offers higher margins compared to large joint reconstruction. The biological/regenerative approach also positions them well in a growing segment of orthopedics focused on tissue preservation rather than replacement. The compelling clinical outcomes provide justification for premium positioning in an increasingly value-focused healthcare environment.

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
Smith+Nephew        david.snyder@smith-nephew.com

* 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.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, which is available on the SEC’s website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.

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FAQ

What is the success rate of Smith+Nephew's REGENETEN implant in rotator cuff repairs?

Clinical trials showed a 87.7% success rate with only 12.3% re-tear rate when using REGENETEN, compared to 64.9% success rate with standard repair.

What new indication has the FDA approved for Smith+Nephew's REGENETEN implant?

The FDA has approved REGENETEN for extra-articular ligament injuries in the US, initially focusing on hip capsule repair with potential for future expansions.

How many REGENETEN procedures has Smith+Nephew performed globally?

Over 150,000 procedures have been completed globally since the implant's introduction in 2014.

What did the AAOS recommend regarding Smith+Nephew's bioinductive implants?

AAOS issued a Strong Recommendation stating that bioinductive tendon implants can lead to lower re-tear rates and better patient reported outcomes in rotator cuff repair.

What were the results of the MALLAMANGUITO trial for SNN's REGENETEN implant?

The two-year trial results showed a 65% relative reduction in re-tear rates with REGENETEN (12.3%) compared to standard repair (35.1%).