RemeOs™ Screw - Magnesium implants
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.
Under the Breakthrough Devices Program, FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Screws in the U.S. market.
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. Now for the first time, surgeons can use safe bioresorbable materials in load-bearing indications. The strength of patented RemeOs™ implants is closer to traditional (stainless steel, titanium) metal implants than polymer implants. With the upcoming RemeOs™ implants, the surgeon can achieve a similar fixation as with traditional metal implants. Also, operation technique principles with RemeOs™ implants are the same as with traditional metal implants.
In many cases, traditional metal implants have to be removed due to long term adverse effects. Removal surgery increases the patient’s discomfort and the risk of complications. RemeOs™ implants eliminate the need for implant removal. Stress-shielding associated with traditional metal implants may result in bone atrophy and osteolysis. RemeOs™ resorbable metal implants resorb into bone, assisting in the healing process. Due to implant resorption, the risks of any implant-related long-term complications will be eliminated.