Inovedis has received the US Food and Drug Administration (FDA) approval for its new implant system, SINEFIX, for rotator cuff tears repair.
Using a simplified surgical technique, the implant system helps refix the rotator cuff tendon to the bone.
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In contrast to traditional surgery, the new technique not only provides effective mechanical reinforcement of the fixed tendon but also stimulates the intrinsic healing capability of the patient.
The staple implant has been designed to create a flat and even contact between tendon and bone.
The device ensures uniform shear stress and prevents punctual pressure peaks while maintaining blood circulation to support the healing process.
It will be inserted using a two-step technique: the base plate is placed in position and the fixation points are driven into the bone using a hammer and the company’s specialised SINEFIX instruments.
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By GlobalDataThis technique helps reduce surgery time and lower the risk of complications due to surgical errors.
Inovedis founder and CEO Lukas Flöss said: “With FDA clearance we will now initiate a first mover application to generate real-world experience in the US to evaluate the potential of the technology.
“We are looking forward to the launch of SINEFIX at the upcoming American Orthopaedic Society for Sports Medicine annual meeting on 13-16 July in Washington DC, followed by enrolling clinical sites into our limited market release to begin gathering experience around SINEFIX.”
Established in 2019, Inovedis concluded a financing round led by High-Tech Gründerfonds after initial funding from the Startup BW PreSeed.
