Smith+Nephew's REGENETEN Bioinductive Implant Supports Rotator Cuff Tear Treatment.

Smith+Nephew, a global medical technology company, has announced new evidence supporting its REGENETEN Bioinductive Implant. The implant is designed to treat rotator cuff tears and other tendon and extra-articular ligament injuries. The American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guideline (CPG) on the Management of Rotator Cuff Injuries now recognizes the value of bioinductive implants in rotator cuff repair. This is based on independent analysis of studies and AAOS CPGs provide evidence-based recommendations for current orthopaedic procedures.

Smith+Nephew (LSE:SN, NYSE:SNN), a global medical technology company, has announced significant updates for its REGENETEN Bioinductive Implant, which is designed to treat rotator cuff tears and other tendon and extra-articular ligament injuries. The company's latest advancements include new clinical evidence and expanded market access, aimed at improving patient outcomes and increasing the adoption of the implant.

The American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guideline (CPG) on the Management of Rotator Cuff Injuries now recognizes the value of bioinductive implants in rotator cuff repair. This recognition is based on independent analysis of studies and aligns with the AAOS CPGs' evidence-based recommendations for current orthopaedic procedures. The AAOS CPG states that the use of bioinductive tendon implants to augment rotator cuff repair or as an alternative to standard repair can lead to lower re-tear rates and better patient-reported outcomes Smith+Nephew unveils major clinical evidence and patient access updates for its REGENETEN™ Bioinductive Implant^[1].

Two-year results from a Randomized Controlled Trial (RCT) conducted by Dr. Miguel A. Ruiz Ibán and colleagues demonstrated a sustained 65% relative reduction in re-tear rates when using the REGENETEN Bioinductive Implant to augment the repair of full-thickness rotator cuff tears . The trial showed that two-year re-tear rates were 12.3% (7/57) with the REGENETEN Implant compared to 35.1% (20/57) with standard repair (p=0.004). These results build on previously reported 1-year results, which have already had a significant impact on patient access and adoption.

Smith+Nephew is also expanding the indications for the REGENETEN Bioinductive Implant in the US to include extra-articular ligament injuries. This new indication will initially focus on hip capsule repair, with potential for future expansions to other extra-articular ligament repairs. The company has completed more than 150,000 procedures globally since the implant's introduction in 2014, highlighting its transformative impact on patients requiring tendon or extra-articular ligament repair .

Scott Schaffner, President Global Sports Medicine at Smith+Nephew, commented, "These significant updates for the REGENETEN Implant are the culmination of many years of hard work from both the Smith+Nephew team and the surgeon community. We are excited about its future potential to treat even more patients who require surgical repair of soft tissue injuries every year."

The REGENETEN Bioinductive Implant is part of Smith+Nephew's comprehensive Advanced Healing Solutions portfolio, which aims to redefine biological healing in rotator cuff repair. Smith+Nephew's portfolio focuses on the repair, regeneration, and replacement of soft and hard tissue, with a mission to restore people's bodies and self-belief through technology.

For more information about Smith+Nephew and the REGENETEN Bioinductive Implant, please visit www.smith-nephew.com.

References:
Smith+Nephew unveils major clinical evidence and patient access updates for its REGENETEN™ Bioinductive Implant^[1] American Academy of Orthopedic Surgeons (AAOS). Rotator Cuff Repair Clinical Practice Guideline. Available at: https://www.aaos.org/quality/quality-programs/rotator-cuff/. [Accessed August 2025].
Ruiz Iban MA, et al. Arthroscopy. Apr 08 2025 [ePub Ahead of Print].
Smith+Nephew. Internal Data.