MINNEAPOLIS, Minn., July 22, 2025 — Inovedis Inc., a pioneering orthopedic technology firm, today announced the successful completion of 50 surgical procedures in the U.S. utilizing its SINEFIX™ Rotator Cuff Repair System. This significant achievement marks a pivotal moment in approaches to soft tissue-to-bone healing. The innovative system aims to revolutionize rotator cuff surgery by addressing both biomechanical fixation and the crucial role of blood flow in tendon-to-bone healing, while also providing a simpler, more effective surgical technique for repairing rotator cuffs.

These initial 50 operations were performed by leading orthopedic surgeons across the United States, including Christopher Dougherty, DO, a prominent figure in sports and orthopedic medicine. Dr. Dougherty remarked, “Following my initial experience with SINEFIX, I observed substantial advantages compared to traditional suture anchors. SINEFIX not only streamlines the repair process by eliminating the need for knot-tying and suture management, but its broad PEEK plate design also evenly distributes load over the tendon, thereby preserving tendon microcirculation and potentially enhancing patient recovery.”

Rotator cuff repairs continue to face unacceptably high failure rates, with a considerable percentage of cases experiencing structural re-tears or non-healing despite advancements in surgical methods. These failures are frequently not due to insufficient initial repair strength—modern suture-anchor constructs are remarkably robust—but rather stem from the mechanical and biological consequences of how sutures interact with tendon tissue during the healing phase. High-strength sutures and tightly secured knots can inadvertently harm the very tissue they are intended to repair, leading to compromised biological healing and eventual mechanical breakdown.

The SINEFIX implant was engineered to overcome the limitations of suture-based fixation, representing a fundamentally different approach to rotator cuff repair. Instead of threads cutting through the tendon, as is common with suture anchors, SINEFIX employs a small polyether-ether-ketone (PEEK) implant that effectively “staples” the tendon to the bone across a wide area. In practice, the device comprises a base that rests on the tendon surface and small fixation prongs driven into the bone, clamping the tendon securely. By fastening a wide section of tendon tissue against the bone, SINEFIX eliminates the concentrated stress points of sutures, ensuring pressure is distributed uniformly across the repair footprint.

“SINEFIX replaces conventional suture anchors and has been shown to reduce surgery time due to its simplified surgical approach. I have noticed that patients treated with SINEFIX experience remarkably low pain levels at three weeks post-surgery and are recovering exceptionally well. As this technology gains widespread adoption, I am confident it will lead to improved patient outcomes, transforming the field of rotator cuff tear surgery and elevating the standard of care,” stated Keith Hall, MD.

Lukas Floess, CEO and co-founder of Inovedis, conveyed his excitement regarding this significant accomplishment, saying, “This crucial achievement highlights Inovedis’ steadfast dedication to the orthopedic community and our commitment to enhancing patient outcomes through continuous innovations in soft tissue-to-bone repair. We are profoundly driven to expand the reach of this vital technology and make it accessible to more surgeons and patients across the U.S. and globally. Reaching 50 successful surgeries is a momentous occasion for Inovedis and signifies merely the beginning for us.”

ABOUT INOVEDIS

Inovedis is an advanced medical technology company committed to providing innovative solutions that both optimize patient care and reduce the complexity of surgical procedures. SINEFIX™, their initial commercially available product designed for rotator cuff tears, aims to transform the approach to rotator cuff surgery by focusing not only on biomechanical fixation but also on 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
ronda.taylor@inovedis.com