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

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Smith & Nephew plc

Sep 14, 2022, 08:00 ET

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.

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Smith+Nephew's REGENETEN Bioinductive Implant
Smith+Nephew's 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:

  1. Patients who received a REGENETEN Bioinductive Implant presented a retear rate of 3.5%. (n=29)
  2. Patients who received a TOE repair alone presented a re-tear rate of 25% which is in-line with published re-tear rates on similar tear types.1,2 (n=28)

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 patients5,9-18,20, the REGENETEN implant has been shown to change the course of tear progression in early studies5-7,19, 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

  1. Kim Y-S, Lee H-J, Jin H-K, Kim S-E, Lee J-W. Conventional En Masse Repair Versus Separate Double-Layer Double-Row Repair for the Treatment of Delaminated Rotator Cuff Tears. The American Journal of Sports Medicine. 2016;44(5):1146-1152
  2. Hein J, Reilly JM, Chae J, Maerz T, Anderson K. Retear Rates After Arthroscopic Single-Row, Double-Row, and Suture Bridge Rotator Cuff Repair at a Minimum of 1 Year of Imaging Follow-up: A Systematic Review. Arthroscopy. 2015 Nov;31(11):2274-81.
  3. Smith + Nephew internal data analysis derived from Decision Resources Group, Global Report 2018 & SmartTRAK DATA Analytics 2022
  4. 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. MLTJ. 2013;3(3):229-235
  5. Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J 2016;6(1):16-25.
  6. 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
  7. 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.
  8. 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.
  9. McIntyre LF, McMillan S, Trenhaile SW, Bishai SK, Bushnell BD. Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry. Arthrosc Sports Med Rehabil. 2021 Aug 20;3(5):e1473-e1479
  10. Bushnell BD, Connor P, Harris HW, Ho CP, Trenhaile SW, Abrams JS. Two-year outcomes with a bioinductive collagen implant used in augmentation of arthroscopic repair of full-thickness rotator cuff tears: Final results of a prospective multi-center study. J Shoulder Elbow Surg. 2022 Jul 1:S1058-2746
  11. Micheloni GM, Salmaso G, Zecchinato G, Giaretta S, Barison E, Momoli A. Bio-inductive implant for rotator cuff repair: our experience and technical notes. Acta Biomed. 2020 Dec 30;91(14-S)
  12. Thon SG, O'Malley L 2nd, O'Brien MJ, Savoie FH 3rd. Evaluation of Healing Rates and Safety With a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes. Am J Sports Med. 2019 Jul;47(8):1901-1908
  13. Arnoczky SP, Bishai SK, Schofield B, Sigman S, Bushnell BD, Hommen JP, Van Kampen C. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017 Feb;33(2):278-283
  14. Camacho-Chacon JA, Cuenca-Espierrez J, Roda-Rojo V, Martin-Martinez A, Calderon-Meza JM, Alvarez-Alegret R, Martin-Hernandez C. Bioinductive collagen implants facilitate tendon regeneration in rotator cuff tears. J Exp Orthop. 2022 Jun 8;9(1):53
  15. Bushnell BD, Bishai SK, Krupp RJ, McMillan S, Schofield BA, Trenhaile SW, McIntyre LF. Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry. Orthop J Sports Med. 2021 Aug 13;9(8
  16. Dai A, Campbell A, Bloom D, Baron S, Begly J, Meislin R. Collagen-Based Bioinductive Implant for Treatment of Partial Thickness Rotator Cuff Tears. Bull Hosp Jt Dis (2013). 2020 Sep;78(3):195-201
  17. Schlegel TF, Abrams JS, Angelo RL, Getelman MH, Ho CP, Bushnell BD. Isolated bioinductive repair of partial-thickness rotator cuff tears using a resorbable bovine collagen implant: two-year radiologic and clinical outcomes from a prospective multicenter study. J Shoulder Elbow Surg. 2021 Aug;30(8):1938-1948
  18. Yeazell S, Lutz A, Bohon H, Shanley E, Thigpen CA, Kissenberth MJ, Pill SG. Increased stiffness and reoperation rate in partial rotator cuff repairs treated with a bovine patch: a propensity-matched trial. J Shoulder Elbow Surg. 2022 Jun;31(6S):S131-S135
  19. McIntyre L, Bishai SK, Brown PB, Bushnell BD, Trenhaile SW. Patient-Reported Outcomes Following Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. Arthroscopy. 2019 35(8):2262-2271
  20. Bokor DJ, Sonnabend D, Deady L et al. Preliminary investigation of a biological augmentation of rotator cuff repairs using a collagen implant: a 2-year MRI follow-up. MLTJ. 2015;5(3):144-150
  21. Smith + Nephew 2019. An overview of the outcomes associated with the standard of care for the surgical treatment of rotator cuff tears. Internal Report EO/SPM/REGENETEN/005/v1.

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

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 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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SOURCE Smith & Nephew plc

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