First Treatments Begin With SINEFIX Rotator Cuff Repair System

The first U.S. patients have undergone treatment with Inovedis Inc.’s SINEFIX Rotator Cuff Repair System, which changes the approach to rotator cuff surgery by addressing the biomechanical fixation and critical role of blood flow in tendon-to-bone healing.

Rotator cuff repairs have historically been plagued by high failure rates despite advancements in surgical techniques. Many traditional methods focus on strengthening the tendon to the bone fixation, but new findings suggest that overemphasis on fixation might actually hinder the healing process. The key, according to Inovedis, lies in minimizing tension and evenly distributing pressure over the largest possible contact surface between tendon and bone, promoting better circulation and biological healing.

“Rotator cuff surgery requires biomechanical stability, but excessive tension can compromise blood flow and slow healing,” explained Dr. Brian Cohen, an orthopedic surgeon involved in SINEFIX’s U.S. launch. “Despite improved fixation methods, retear rates remain high. The SINEFIX implant controls compression without straining the tendon, preserving blood flow and potentially setting a new standard in rotator cuff repair.”

The SINEFIX system, designed for tendon ruptures up to 2 cm, features a simplified two-step process using a PEEK (polyether ether ketone) plate and two PEEK anchors, equipped with additional teeth to prevent tendon slippage. This design keeps the tendon vital by maintaining blood circulation, which is essential for biological healing. The system eliminates the need for complex suture management, making it a more accessible technique for surgeons and improving patient outcomes.

“Rotator cuff repair surgeries are among the most common soft tissue procedures, with over half a million performed each year in the U.S. alone,” Inovedis Co-Founder and SINEFIX inventor Dr. Stefan Welte stated. “Unfortunately, traditional methods using suture anchors have not yielded significant improvements in patient recovery. Our vision is to revolutionize biomechanical fixation and enhance biological healing. The success of these first cases in the U.S. brings us closer to that goal.”

SINEFIX’s introduction represents a potential turning point in rotator cuff injury treatment, offering new hope for improved recovery and long-term healing.

“The simplicity of SINEFIX’s surgical technique, which eliminates the need for knot tying, is a critical step toward making this groundbreaking technology available to surgeons worldwide,” Inovedis CEO Tom Anstead. “Our first successful cases in the U.S. mark a significant achievement for our team.”

Inovedis is a medical technology startup offering innovative solutions that optimize patient care and minimize the complexity of surgical interventions.  Since its founding in 2019, Inovedis has been developing SINEFIX to simplify rotator cuff tear surgery and improve patient outcomes. SINEFIX received U.S. Food and Drug Administration clearance in 2023.

SINEFIX is not approved for sale outside the United States.