Press Release
medical magnesium receives FDA Breakthrough Device designation for their bioabsorbable traumaorthopedic plate system based on mm.X magnesium implant platform
Jan. 11, 2023, 11:00 CET
Aachen, Germany, Jan. 11, 2023/ — medical magnesium GmbH, a Aachen-based medtech company creating bioabsorbable implants, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device status for their orthopedic and trauma care plate system.
„The Breakthrough Device designation for our bioabsorbable orthopedic plates recognizes our ability to address one of the biggest unmet clinical needs in orthopedic surgery and traumatology,” said Kilian Reuß, CEO and co-founder of medical magnesium. Routinely performed surgical removal of conventional implants is undoubtedly a major burden for patients, especially in pediatric surgery. The bioabsorbable plate system will eliminate this burden and reduces the total costs of care significantly.
The mm.X plate system is currently under development and has shown tremendous potential in in-vitro and in-vivo tests. “The breakthrough device designation allows us to regularly synchronize our development process with the FDA and to clearly meet the patients‘ and physician‘s requirements for safe and well-
performing medical devices early on. The on-going collection of promising clinical data on other products of the mm.X family currently marketed in Europe further enriches the exchange with the FDA greatly.” Dr. Michael Gertig, VP Regulatory & Clinical Affairs
About medical magnesium
medical magnesium is a medtech company for bioabsorbable implants based in Aachen, Germany – founded in 2018 by Florian Coppers, Kilian Reuß from RWTH Aachen University. The high-tech company offers a wide range of CE marked bioabsorbable magnesium implants in Europe to a growing number of orthopedic surgeons recognizing the need for a single surgery therapy the and value for their patients. medical magnesium seeks to provide this kind of treatment to American patients soon.
About the FDA Breakthrough Device Program
The FDA Breakthrough Device program enables expedited regulatory assessment of novel technologies with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency‘s mission to protect and promote public health.
Contact
Kilian Reuß
Medical Magnesium GmbH
Philipsstraße 8
52068 Aachen
info@medical-magnesium.com
+49 241 927845023
