17 Jun Smith+Nephew’s revolutionary REGENETEN™ Bioinductive Implant receives CE Mark
Supports the body’s natural healing response to facilitate new tendon-like tissue growth for rotator cuff repairs.1-5
LONDON, June 16, 2020 /PRNewswire/ — Smith+Nephew (LSE:SN,NYSE:SNN), the global medical technology business, is pleased to announced that its REGENETEN Bioinductive Implant has successfully received CE Mark certification allowing the implant to now be used and sold in key European markets. With more than 40,000 procedures completed since its US introduction, the REGENETEN implant has had a transformative impact on the way surgeons approach rotator cuff procedures.
The collagen-based REGENETEN Bioinductive Implant supports the body’s natural healing response by inducing the growth of new tendon-like tissue1-3,6 to biologically augment the existing tendon and disrupt 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 is completely resorbed within six months.*7
“This is the most exciting advance in the field of rotator cuff surgery in my career and has the prospect of completely transforming patient outcomes,” commented Mr Chris Peach, Consultant Shoulder and Elbow Surgeon, Orthteam Centre, UK and Chairman of the Research Committee of the British Elbow and Shoulder Society. “A biologics solution for a biologic problem; a completely new approach for rotator cuff tear repair and reinforcement that will change patient outcomes,” added Prof Emilio Calvo, MD, PhD, MBA, Shoulder and Elbow Reconstructive Surgery Unit, Universidad Autónoma, Spain.
The REGENETEN Bioinductive Implant arrives in Europe with extensive clinical evidence covering the entire spectrum of rotator cuff disease, from partial thickness tears2 to difficult-to-treat large (3-5cm) and massive (5cm+) thickness tears6.
“I am very excited about this new product. Biological enhancement and tendon regeneration is the way forward. I believe REGENETEN is changing the way we think about and manage rotator cuff pathology. We can now expect consistent improvement in patient outcomes,” commented Carlos Cobiella LMS FRCS Ed (Tr & Orth), Consultant Shoulder & Elbow and Sports Surgeon, University College Hospital, London, UK.
The implant will be available to use on the 310,000+ rotator cuff procedures that take place each year in Europe in a market that is worth an estimated $175 million annually8.
“We are delighted to gain CE Mark for REGENETEN and be able to offer up this ground-breaking technology to our customers in Europe,” commented Terry Byca, Senior Director Marketing EMEA, Smith+Nephew. “The US market has demonstrated over the last five years that REGENETEN is changing surgeons traditional approach to rotator cuff repair; biological healing is imperative and our Advanced Healing shoulder repair products together with REGENETEN take us into a new era for joint repair.”
*On human biopsy (n=1) and in-vivo sampling
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Smith+Nephew, Internal Market Procedure Data
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 16,000+ 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 $4.9 billion in 2018. 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.
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: economic and financial conditions in the markets we serve, especially those affecting health care 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 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 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. © 2019 Smith+Nephew. All rights reserved.