11 July 2023

Smith+Nephew launches REGENETEN◊ Bioinductive Implant in India for rotator cuff repair

Supports the body’s natural healing response to facilitate new tendon-like tissue growth and changes the course of rotator cuff disease progression1-5

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces the launch of its REGENETEN Bioinductive Implant in India. With more than 100,000 procedures completed globally since its introduction, the REGENETEN implant has had a transformative impact on the way surgeons approach rotator cuff procedures.

 

REGENETEN Patch.tif

The collagen-based REGENETEN Bioinductive Implant supports the body’s natural healing response to facilitate the growth of new tendon-like tissue1-3,6 to biologically augment the existing tendon and change the course of disease progression.1-5 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 by 6 months, the implant is no longer visible, with new tendon-like tissue and oriented collagen suggestive of functional loading.*7

The REGENETEN Bioinductive Implant arrives in India with more than 10 years of clinically demonstrated results in 18 studies covering the entire spectrum of rotator cuff disease, from partial thickness tears2 to large (3-5cm) and massive (5cm+) full-thickness tears.6 Most recently, new data from a triple-blinded randomized controlled trial has shown that the addition of the REGENETEN Bioinductive Implant to a conventional rotator cuff repair delivers a relative reduction of 86% in re-tear rates at 12 months vs. conventional surgery alone.8

The prevalence of rotator cuff disease in India was estimated to be 150,000 in 2022 with approximately 28,000 patients undergoing rotator cuff repair procedures. The total rotator cuff repair market in India is expected to reach 33,000 cases in 2023 and 39,000 in 2024, with year-over-year growth of 15%.9

“We are beyond excited to bring the REGENETEN Bioinductive Implant to India and advance the standard of care for patients suffering from rotator cuff disease,” commented Joaquin Lasso, Managing Director, South Asia for Smith+Nephew. “The clinical evidence speaks for itself – REGENETEN Bioinductive Implant is changing the game in rotator cuff repair and generating positive outcomes for thousands of patients all over the world.”

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.

 

Enquiries

Media

 

Dave Snyder

+1 978 749 1440

Smith+Nephew

 

 

 

About Smith+Nephew

Smith+Nephew is a portfolio medical technology company 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 19,000 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 2022. 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, 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; 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); 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); 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.

◊ Trademark of Smith+Nephew. Certain marks registered US Patent and Trademark Office.

References
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Thon SG, O’Malley L, O’Brien MJ, Savoie FH. 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;47(8):1901-1908.
  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
  8. Ruiz Iban MA, García Navlet M, Moros Marco S, et al. The Effect On Healing Rate Of The Addition Of A Bioinductive Implant To A Rotator Cuff Repair. Preliminary Report. SECEC. 2022.
  9. Smith+Nephew, Internal Market Procedure Data

 

Title

Text

Explore