The company´s next-generation patented bioresorbable metal, RemeOs™, is in the clinical phase with promising interim results. RemeOs™ is based on naturally occurring essential metals in the human body: magnesium, zinc and calcium. The material does not contain any rare-earth elements (REE), foreign to the human body like Yttrium, Gadolinium, Neodymium, nor any other (REE).
RemeOs™ Screw has received Breakthrough Device Designation from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in traumatology and orthopedic surgery. FDA requires breakthrough technology to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions or diseases. In addition, breakthrough technology must either represent a completely new form of treatment or offer significant advantages over existing approved or cleared alternatives, including the potential to reduce the need for hospitalization, improve patients’ quality of life and create long-term clinical benefit, or alternatively represent a form of treatment that is in the best interest of patients.
Clinical trials have shown excellent results proving the safety and functionality of the material. Its high mechanical properties and degradation characteristics are well suitable for load-bearing clinical applications as well as in pediatrics. This alloy has been developed over the course of eight years and marks an important milestone in materials research.