Rotator Cuff Injuries

Data published online in Arthroscopy highlighted the success of Regeneten against the standard of care. One-year results found that medium and large full-thickness rotator cuff tears repaired and augmented with the implant had better tendon healing. Regeneten provides a patient-centric treatment supporting the body’s natural healing process, according to S+N. The aim is for the collagen-based implant to change the course of tear progression, aid return to normal activity and reduce re-tears compared to conventional surgery. Smith+Nephew previously reported positive data on the implant in September 2022. About the data from Smith+Nephew Results included a significantly lower re-tear rate, at 8.3% with Regeneten against 25.8% with the standard of care. The implant also had a three-times lower risk of re-tear and no difference in the number of serious or minor complications. The blinded, multi-center trial compared the healing rate of the tears with and without augmentation with Regeneten. In total, 124 patients with repairable medium and large full-thickness posterosuperior rotator cuff tears were randomized to receive either an arthroscopic transosseous equivalent double-row rotator cuff repair or the same repair augmented with Regeneten. Dr. Miguel Ruiz Ibán, the study’s principal investigator, said the trial showed substantial, significant reduction in re-tear risk. The head of the shoulder and elbow unit at Hospital Universitario Ramón y Cajal in Madrid, Spain, said data supports the use of the implants to reduce re-tear rates in the studied population. “Smith+Nephew is committed to proving the value of our technology through support for clinical evidence generation. “We are pleased and excited by the opportunity presented by this evidence to drive adoption of, and access to, the Regeneten bioinductive implant,” said Christie Van Geffen, SVP sports medicine global marketing at Smith+Nephew. “Our goal is to help surgeons improve the care of many more patients with rotator cuff injuries.”

First published randomized controlled trial for market-leading implant demonstrates impressive outcomes for rotator cuff tears Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces standout results for its REGENETEN Bioinductive Implant from a recently completed randomized controlled trial (RCT). Published online in Arthroscopy in December, the report concluded that at one-year, medium and large full-thickness rotator cuff tears repaired and augmented with the REGENETEN Bioinductive Implant had better tendon healing compared to the standard of care,1 as evidenced by: A significantly lower re-tear rate (8.3 vs 25.8%; p=0.01)A three times lower risk of re-tear (RR=0.32; 95% CI:0.13–0.83)No difference in the number of serious or minor complications The blinded, multi-centre RCT compared the healing rate of full-thickness rotator cuff tears repaired with and without augmentation with the REGENETEN Bioinductive Implant. In total, 124 patients with reparable medium and large (1–4cm) full-thickness posterosuperior rotator cuff tears were randomized to receive either an arthroscopic transosseous equivalent double-row rotator cuff repair or the same repair augmented with the REGENETEN Bioinductive Implant. Dr. Miguel Ruiz Ibán, Head of the Shoulder and Elbow Unit at Hospital Universitario Ramón y Cajal in Madrid, Spain, and Principal Investigator for the study commented on the results, “Rotator cuff repair is traditionally associated with re-tear rates in excess of 20%, presenting a challenge for surgeons and patients alike. This RCT demonstrates that the REGENETEN Bioinductive Implant substantially and significantly reduced this risk. With no increase in complications seen in our study, these findings support the use of the implant to reduce re-tear rates in the population studied.” With more than 100,000 procedures completed globally since its introduction in 2014, the REGENETEN Bioinductive Implant has had a transformative impact, offering a better solution for more than 1 million2 people having surgery for a rotator cuff tear each year. The collagen-based implant supports the body’s natural healing response to facilitate the formation of new tendon-like tissue to biologically augment the existing tendon and change the course of rotator cuff tear progression.1,3-8 Smith+Nephew's REGENETEN Bioinductive Implant “Smith+Nephew is committed to proving the value of our technology through support for clinical evidence generation,” said Christie Van Geffen, SVP Sports Medicine Global Marketing at Smith+Nephew. “We are pleased and excited by the opportunity presented by this evidence to drive adoption of, and access to, the REGENETEN Bioinductive Implant. Our goal is to help surgeons improve the care of many more patients with rotator cuff injuries.” 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. - ends - Media Enquiries David SnyderSmith+Nephew +1 978-749-1440 david.snyder@smith-nephew.com References Ruiz Ibán MA, Navlet MG, Marco SM, et al. Augmentation of a transosseous equivalent repair in posterosuperior non-acute rotator cuff tears with a bioinductive collagen implant decreases the re-tear rate at one year. A randomised controlled trial. Arthroscopy. Published online 12/27/2023.iData Research. Rotator cuff repair and reconstruction market size, share and trends analysis (2023). Available at: https://idataresearch.com/product/rotator-cuff-repair-reconstruction-market-size-share-and-trends-analysis-global-2023-2029-medsuite-includes-grafts-allografts-xenograft-synthetic-and-1-more/#. Accessed December 19, 2023.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.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 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. About Smith+NephewSmith+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 business units 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 X, LinkedIn, Instagram or Facebook. Forward-looking StatementsThis 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. 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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 healthcare 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 and financial 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; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; 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, which is available on the SEC’s website at www. sec.gov, 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 in US Patent and Trademark Office. Smith+Nephew's REGENETEN Bioinductive Implant Attachment REGENETEN Patch 2024

Raises $4 Million in New Equity Funding ALBSTADT, Germany, Oct. 5, 2023 /PRNewswire/ -- Inovedis GmbH, a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions, announced the successful close of a Series A funding round totaling $4 million. This funding was supported by participation from all of Inovedis's initial seed round investors including High-Tech Gründerfonds, MBG Mittelständische Beteiligungsgesellschaft Baden-Württemberg, Volksbank Albstadt ChancenKapital, Start-UP BW Innovation Fonds, angel investors, and an initial investment by Renolit SE, the current manufacturer of the SINEFIX implant. Inovedis will use the recent funding to support the commercial launch of the SINEFIX® implant system in the United States where there are over 1 million rotator cuff surgeries each year. The funding will also go towards sponsoring a clinical study taking place in Germany to generate data needed in support of CE marking and expansion of sales into Europe. SINEFIX allows refixation of the rotator cuff tendon to bone with a simplified surgical technique optimized for minimally invasive surgery. The new technique requires minimal instrumentation, and removes the complexity of suture management and knot tying which is time-consuming, and requires an extensive range of instruments. According to Prof. Dr. Philip Kasten, orthopedic surgeon and lead investigator in the SINEFIX CE mark clinical study, "Approximately 70% of all patients have a partial thickness rotator cuff tear, while only 28% have a full thickness tear. SINEFIX offers an effective treatment solution for small and partial thickness tears. In contrast to current treatment options, there is no need to detach the tendon completely prior to reattachment and fills an important gap in treating rotator cuff patients." "The SINEFIX surgical technique will shorten the procedure time and potentially improve the tendon to bone fixation while using less implants," says Dr. Stefan Welte, inventor of SINEFIX and co-founder. "This is due to the higher pull-out forces than double row fixation with suture anchors allowing the implant to be used in porous bones. This simplified technique is designed to reduce the risk of complications due to surgical errors and significantly shortens surgery time, contributing to time and cost savings in clinical surgeries." "The new funding brings significant financial capital to accelerate the launch of SINEFIX and innovations that promote improvements in the way rotator cuff tears are treated today," says Lukas Flöss, Founder and CEO. "We are looking forward to starting a limited market release in the U.S. to begin gathering experience around SINEFIX and working on future product generations." ABOUT INOVEDIS Inovedis GmbH is a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions. Since its founding in 2019, Inovedis has been developing SINEFIX™ to simplify rotator cuff tear surgery and improve patient outcomes. SINEFIX received FDA clearance in 2023. SINEFIX is not approved for sale outside the U.S. To learn more, visit our website and follow us on LinkedIn. MEDIA CONTACT: Lukas Flöss, Founder and CEO [email protected] Phone: +49 (0) 7432 - 13099 20 Logo - SOURCE Inovedis GmbH