Medical Magnesium ready for EU market entry

EIT Health Catapult Finalist announces EU market entry thanks to their recent CE mark achievement for its resorbable implant systems based on their mm.X technology. 

At the end of last year, EIT Health Alumni and medtech spin-off of EIT Health´s core partner RWTH Aachen, medical magnesium has reported that their three innovative implant systems (1.) Interference screw mm.IF , (2.) Compression screw mm.CS and (3.) Arthrodesis implant mm.PIP have obtained CE mark in the medical device highest risk class and are in the starting blocks to revolutionize the European sports, extremity and traumatology surgery market in 28 countries.

The high-tech company medical magnesium develops metallic bioabsorbable implants for orthopaedic and trauma surgery made of magnesium. The implants are mechanically stable and physiologically degradable after fracture healing. A second surgery to remove the implants becomes needless and subsequently relieves both patients and the healthcare system.

In the case of bone fractures, doctors use plates or screws to fix the traumatized bone parts and to allow them to grow together again. In a second operation, the implants are removed after 12 to 18 months. This is necessary to avert the risk of infection from permanent implants and to eliminate “stress shielding”. Stress shielding refers to the reduction in bone density as a result of the removal of normal stress from the bone by an implant. This phenomenon is becoming a thing of the past thanks to the mm.X implant technology developed by the engineers Florian Coppers and Kilian Reuß, both graduates of RWTH Aachen. Their implants are made of magnesium, which is more than suitable as an implant material. Contrary to the standard used resorbable polymer materials or biocomposite ceramics, magnesium has the strength of a metal and the ability to be biologically absorbed and converted into magnesium oxide and hydrogen gas in the body. The two reaction products are safely processed and an intact bone structure is formed at the former implant site. As a result, the implants are able to safely stabilize fractures up to the point of healing.

The resorbable mm.X implant systems have been developed and manufactured in Germany. Its successful biocompatibility can be guaranteed thanks testing in former preclinical studies and laboratory chemistry. The hydrogen produced by the degradation process could be reduced to a minimum level so that it is tolerated by the body. This is made possible through a special alloying process and a surface modification. Here are medical magnesium´s three implant systems based on mm.X technology which have received approvals and are now ready to conquer the European market: The (1.) interference screw mm.IF (available in all standard lengths and diameters) is intended for use in reconstructive surgery after soft tissue injuries, for fixation of cruciate ligament transplants, and other applications. The mm.IF screw securely fixes a graft, which is usually autologous to the body, so that complete healing is ensured. The (2.) compression screw mm.CS (available in three diameters and different lengths) will be used in traumatology and osteosynthesis. The mm.CS fixes bone fragments securely and primarily stable in order to ensure a controlled healing process. Wearing tight shoes may often lead to malpositions of the forefoot like a hammer or claw toe malalignment. Through the (3.) arthrodesis implant mm.PIP (available in various anatomical sizes, angles and lengths) the toe is directed into its natural anatomical position.

Our vision is to enable surgeons to improve patient care through our highly functional resorbable mm.X implants. Our first market approvals now open up exactly this path and more implants […] are already in development”, states Kilian Reuß, CEO and Co-founder of medical magnesium.