Study shows Smith+Nephew's REGENETEN◊ Bioinductive Implant sets new standard of recovery for partial-thickness rotator cuff tears

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Smith & Nephew plc

21 Jul, 2021, 12:00 GMT

LONDON, July 21, 2021 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, today announces study results showing patients treated with just its REGENETEN Bioinductive Implant for partial-thickness rotator cuff tears (>3mm) experienced significantly improved shoulder function during early recovery compared to patients receiving a REGENETEN Implant plus traditional surgical repair, with equivalent efficacy at one year.1  

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Presented at the AOSSM-AANA Combined 2021 Annual Meeting, study investigators compared the use of a REGENETEN Implant alone (without surgical repair) to a REGENETEN Implant plus traditional surgical repair for the treatment of partial-thickness rotator cuff tears in 227 patients across 19 US surgical centers.

Key findings of the study included:

  • Compared with traditional surgical repair, patients reported a significant improvement in shoulder function in the early post-operative period (weeks 2 and 6) with the REGENETEN Implant alone
  • Treatment with the REGENETEN Implant alone demonstrated equivalent efficacy to REGENETEN plus traditional surgical repair with minimal revisions across both treatment groups at 1 year
  • Among all patients receiving a REGENETEN Implant, patients reported significant improvements in pain, function and quality of life from at 1 year compared with pre-surgery values

"The results of this pioneering study show that using REGENETEN alone simplifies the surgical procedure. It is less invasive and can potentially lower risk of complications when compared with the current standard of care," said Dr. Brad Bushnell, Chairman of the Orthopedic Department at the Harbin Clinic. "Using REGENETEN alone gives my patients the best chance for a quicker recovery with less pain and greater function."

Smith+Nephew's collagen-based REGENETEN Bioinductive Implant supports the body's natural healing response by inducing the growth of new tendon-like tissue2-5 to biologically augment the existing tendon and disrupt disease progression.2-6 Delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury, the implant is about the size of a postage stamp and is completely resorbed within six months.*4,7

"Since its introduction in 2014, the REGENETEN Implant has had a transformative impact on the way surgeons approach rotator cuff procedures," said Scott Schaffner, SVP and GM, Global Sports Medicine, Smith+Nephew. "As access to the REGENETEN Implant expands and we continue to gather data, we're excited to learn about the short and longer-term benefits it delivers to patients to help them live their life unlimited." 

Smith+Nephew's REGENETEN Bioinductive Implant is available in the US, Europe and other select countries worldwide. To learn more about the REGENETEN Implant, please visit https://rediscoveryourgo.com/shoulder-technology/regeneten-bioinductive-implant/

*On human biopsy (n=1) and in-vivo sampling

References

  1. Bushnell BD, et al. Treatment of partial-thickness rotator cuff tear repairs with a resorbable bioinductive bovine collagen implant: 1-year results from a prospective multi-center registry. Presented at: AOSSM-AANA Combined 2021 Annual Meeting, July 7-11, Nashville, Tennessee.
  2. 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.
  3. 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.
  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. Muscles Ligaments Tendons J. 2013;3(3):229-235.
  5. 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.
  6. 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.
  7. 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

About Smith+Nephew
Smith+Nephew is a portfolio medical technology business that exists 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, Advanced Wound Management and Sports Medicine & ENT.

Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $4.6 billion in 2020. 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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