New randomized controlled trial shows that addition of Smith+Nephew's REGENETEN™ Bioinductive Implant delivers 86% reduction in rotator cuff re-tear rates at 12 months

LONDON, Sept. 14, 2022 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE: SNN), the global medical technology company, today announces promising new data furthering a number of published studies supporting the use of its REGENETEN Bioinductive Implant in rotator cuff repair. Interim analysis from a randomized controlled trial (RCT) shows a significant reduction in the re-tear rate of full-thickness rotator cuff repairs when using the REGENETEN Bioinductive Implant.

The multicentre, triple-blinded RCT results were presented last week by Prof. Miguel Angel Ruiz-Ibán, MD., PhD., Hospital Universitario Ramon Y Cajal, Madrid Spain, at the 2022 SECEC-ESSE Congress in Dublin, Ireland. Re-tear rates of patients with medium to large full-thickness tears were measured following either an arthroscopic supraspinatus transosseous equivalent (TOE) repair alone, or the same TOE repair with the addition of a REGENETEN Bioinductive Implant.

At 12 months follow-up, repairs with the added REGENETEN Bioinductive Implant resulted in significantly lower re-tear rates than those with a TOE repair alone (p= 0.022). Specifically, the RCT reported:

There were no differences in postoperative complications between groups.  

"Traditional rotator cuff procedures and the resulting re-tear rates present a challenge and a concern for both surgeons and patients alike," commented Prof. Ruiz-Ibán. "The interim results from this RCT are encouraging and indicate that the Smith+Nephew REGENETEN Bioinductive Implant may significantly improve re-tear rates. I look forward to the completion of this investigation in 2023 and further use of the implant."

With the potential to aid approximately 545,000 annual rotator cuff procedures, globally³, the REGENETEN Bioinductive Implant provides a patient centric treatment supporting the body's natural healing response to facilitate healing of rotator cuff tears.^4-8 With at least 12 published clinical studies including 709 patients^5,9-18,20, the REGENETEN implant has been shown to change the course of tear progression in early studies^5-7,19, aid return to normal activity¹⁹ and reduce re-tears versus conventional surgery.^20,21

"New RCT evidence supporting the use of our REGENETEN™ Bioinductive Implant for improved patient outcomes continues to grow," said Christie Van Geffen, VP Sports Medicine Joint Repair at Smith+Nephew. "No other bioinductive treatment has the amount of science behind it supporting the clinical value for thousands of patients with rotator cuff tears."  

The REGENETEN Bioinductive Implant is part of Smith+Nephew's comprehensive Advanced Healing Solutions portfolio - redefining biological healing in rotator cuff repair along with expanded applications for Gluteus Medius and Achilles tears.^* To learn more about the REGENETEN Bioinductive Implant, please click here.

References

*The REGENETEN implant is currently approved for use in treating Gluteus Medius and Achilles tears only in the U.S.

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 18,000 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 franchises of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.2 billion in 2021. 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 Twitter, 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 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: risks related to the impact of COVID-19, such as the depth and longevity of its impact, government actions and other restrictive measures taken in response, material delays and cancellations of elective procedures, reduced procedure capacity at medical facilities, restricted access for sales representatives to medical facilities, or our ability to execute business continuity plans as a result of COVID-19; economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers (including, without limitation, as a result of COVID-19); 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 compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers (including, without limitation, as a result of COVID-19); competition for qualified personnel; strategic actions, including acquisitions and dispositions, 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; 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, 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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