Smith+Nephew (NYSE: SNN) today announced new evidence highlighting the clinical performance of its Regeneten bioinductive implant.
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.
Two-year results from the MALLAMANGUITO trial demonstrated a sustained 65% relative reduction in re-tear rates with Regeneten. It evaluated the implant in augmenting the repair of full-thickness rotator cuff tears. Two-year re-tear rates came in at 12.3% (7/57) with Regeneten, compared to 35.1% (20/57) with standard repair.
Smith+Nephew previously reported positive data on the implant in September 2022, then added more evidence in January 2024. It says the latest data support its further adoption as it continues to substantially invest in research to expand access and indications.
The company also said that AAOS issued a clinical practice guideline (CPG) on the management of rotator cuff injuries. This highlights the value of bioinductive implants in rotator cuff repair, according to Smith+Nephew.
Additionally, the company said it can, for the first time, market Regeneten for extra-articular ligament injuries in the U.S. The new indication expansion offers opportunities to reach more patients with soft tissue injuries throughout the body. Smith+Nephew plans to initially focus on hip capsule repair with abundant opportunities for future expansions in other extra-articular ligament repairs.
“These significant updates for the Regeneten implant are the culmination of many years of hard work from both the Smith+Nephew team and surgeon community,” said Scott Schaffner, president of Global Sports Medicine at Smith+Nephew. “We are excited about its future potential to treat even more patients who require surgical repair of soft tissue injuries every year.”
