MAGNESIUM DEVELOPMENT COMPANY ANNOUNCES FDA BREAKTHROUGH DEVICE DESIGNATION FOR RESORBABLE HC SCREW

GRAND RAPIDS, Mich., Jan. 24, 2022 /PRNewswire/ -- Magnesium Development Company (MDC), a company with an innovative magnesium (Mg) alloy technology set out to solve what seemed to be an unsolvable problem: the need for a material for use in multiple orthopedic applications that provides appropriate strength for a given indication while not interfering with imaging or requiring the need for future hardware removal procedures. MDC's fixation solution, the HC Screw, has received the FDA's Breakthrough Device designation, having exceeded the criteria required for participation in the Breakthrough Device Program. The objective of this program is to streamline the regulatory review process for qualifying medical devices that treat debilitating diseases and shorten the time required to get breakthrough technologies into clinical use to benefit both patients and healthcare providers.

Mark Hanes, PhD, Senior Technical Director, said, "MDC was founded on the belief that a resorbable metal technology has the potential to significantly advance the treatment of patients in orthopedics. MDC is developing implants utilizing BioMg 250, a patented alloy composition that contains a unique blend of Magnesium and other elements, all of which are essential for healthy bone formation.  Notably, MDC's proprietary alloy does not make use of rare earth elements, and accomplishes the objectives for the material technology through a combination of alloying and mechanical formation processes. Our HC Screw is an exclusive and proprietary technology that has been formulated to provide the strength and handling properties of metal during the healing process and then fully resorbs when no longer needed. The alloy's radiolucency is similar to cortical bone and thus does not produce imaging artifacts that are common with other metallic implants. Magnesium alloys have the potential to provide a significant advancement in the standard of care for orthopedics and we are proud to bring this material technology to market."

Rob Ball, a member of MDC's Board of Directors said, "MDC has been working for an extensive period of time to establish the scientific foundation which proves the benefits that can be derived from this unique and exciting material technology. It is encouraging to understand that FDA recognizes the opportunity to benefit a wide range of patients."

The company's many targeted devices may include devices for repair and reconstruction of foot and ankle conditions, as well as addressing sports medicine applications. For more information, visit MDC online at https://magnesiumdevelopment.com.

SOURCE Magnesium Development Company

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