Inovedis Hits 50-Case Milestone with SINEFIX™, a Breakthrough in Rotator Cuff Repair

MINNEAPOLIS, July 24, 2025 /PRNewswire/ -- Inovedis Inc., an innovative orthopedic technology company, today announced the completion of 50 successful surgeries using its SINEFIX™ Rotator Cuff Repair System in the U.S., a major milestone that signals a shift in soft tissue-to-bone healing approaches. This breakthrough system aims to transform the approach to rotator cuff surgery by addressing biomechanical fixation and the critical role of blood flow in tendon-to-bone healing while offering a simpler, more effective surgical technique for rotator cuff repair surgery.

These initial 50 surgeries were completed with key orthopedic surgeons throughout the United States including Christopher Dougherty, DO, a leader in sports and orthopedic medicine. "After the initial use of SINEFIX, I saw the immense benefits provided versus traditional suture anchors," commented Dr. Dougherty. "Not only does SINEFIX simplify the repair sequence by eliminating knot-tying and suture management, its broad PEEK plate design distributes load evenly over the tendon preserving tendon microcirculation and potentially improving patient healing."

Rotator cuff repairs continue to experience unacceptably high failure rates, with structural re-tear or non-healing reported in a substantial fraction of cases despite advances in surgical technique. These failures are often not due to inadequate initial repair strength, in fact, modern suture-anchor constructs are extremely strong, but rather due to the mechanical and biological consequences of how sutures interact with tendon tissue during healing. High-strength sutures and tightly tied knots can inadvertently damage the very tissue they are meant to fix, leading to compromised biology and eventual mechanical failure.

The SINEFIX implant was designed to address the shortcomings of suture-based fixation and represents a completely different approach to rotator cuff repair. Rather than threads cutting through tendon as with suture anchors, SINEFIX uses a small polyether-ether-ketone (PEEK) implant that effectively "staples" the tendon to bone over a broad area. In practice, the device consists of a base that sits on the tendon surface and small fixation prongs that are driven into bone, clamping the tendon down. By securing a wide swath of tendon tissue against the bone, SINEFIX eliminates the point-loading of sutures – there are no concentrated suture anchor points. The pressure is distributed evenly across the repair footprint.

"SINEFIX replaces traditional suture anchors and has proved to reduce surgery time due to its' simplified surgical technique. I have observed that patients treated with SINEFIX have shockingly very low pain at 3 weeks after surgery and are doing significantly well. As this technology becomes widely adopted, I am confident that it will drive better outcomes for patients, revolutionizing the field of rotator cuff tear surgery and improving the standard of care." Keith Hall, MD.

Lukas Floess, CEO and co-founder of Inovedis, expressed his enthusiasm for this groundbreaking achievement, stating, "This pivotal accomplishment underscores Inovedis' unwavering commitment to the orthopedic community and our dedication to improving patient outcomes through continuous advancements in soft tissue to bone repair. We are immensely motivated to expand the reach of this essential technology and make it accessible to more surgeons and patients in the US and globally. Reaching 50 successful surgeries is a huge milestone for Inovedis and is just the very beginning for us."

ABOUT INOVEDIS

Inovedis is a cutting-edge medical technology company dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions. SINEFIX™, their first commercially available product designed for rotator cuff tears, aims to transform the approach to rotator cuff surgery by addressing not just biomechanical fixation, but the critical role of blood flow in tendon-to-bone healing.

SINEFIX is not approved for sale outside the U.S.

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MEDIA CONTACT:
Ronda Taylor
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SOURCE Inovedis Inc.