Inovedis Marks First Milestone With Rotator Cuff Repair Solution

Inovedis Inc. has completed 50 successful surgeries in the United States using its SINEFIX Rotator Cuff Repair System, a solution that represents a change in soft tissue-to-bone healing approaches.

“This pivotal accomplishment underscores Inovedis’ commitment to the orthopedic community and our dedication to improving patient outcomes through continuous advancements in soft tissue to bone repair,” Inovedis Co-Founder/CEO Lukas Floess said. “We are immensely motivated to expand the reach of this technology and make it accessible to more surgeons and patients in the U.S. and globally. Reaching 50 successful surgeries is a huge milestone for Inovedis and is just the very beginning for us.”

The system attempts 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.

The initial 50 surgeries were completed with key orthopedic surgeons throughout the United States including Christopher Dougherty, D.O., a sports/orthopedic surgeon. “After the initial use of SINEFIX, I saw the immense benefits provided versus traditional suture anchors,” Dr. Dougherty said. “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, as modern suture-anchor constructs are extremely strong. Rather, failures occur because of the mechanical and biological consequences of the way sutures interact with tendon tissue during healing. High-strength sutures and tightly tied knots can inadvertently damage the tissue they are meant to fix, leading to compromised biology and eventual mechanical failure.

The SINEFIX implant is designed to address the shortcomings of suture-based fixation and represents a completely different approach to rotator cuff repair, according to Inovedis. Rather than threads cutting through tendon as with suture anchors, SINEFIX uses a small polyetheretherketone (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 three weeks after surgery and are doing significantly well. As this technology becomes widely adopted, I am confident it will drive better outcomes for patients, revolutionizing the field of rotator cuff tear surgery and improving the standard of care,” stated Keith Hall, M.D.

Inovedis is a medical technology company offering solutions that contribute optimized patient care and minimize the complexity of surgical interventions. SINEFIX, the company’s first commercially available product designed for rotator cuff tears, aims to transform the approach to rotator cuff surgery by addressing both biomechanical fixation and the critical role of blood flow in tendon-to-bone healing.

SINEFIX is not approved for sale outside the United States.