nanoMAG has invented a bioabsorbable magnesium metal alloy, BioMg 250, for craniomaxillofacial trauma and reconstruction fixation (1,2,3). This novel and proprietary alloy is intended to obviate the cost and pain of secondary removal surgery, required for 20% of patients with existing absorbable and non-absorbable implants. BioMg 250?s biocompatible chemistry and novel nanostructure afford application in self-tapping screws and load-bearing CMF fixation systems, which is not possible for bioabsorbable polymers. With the support of NIH grant R44DE024919-0351, nanoMAG has completed through 78 weeks a BioMg mandible fixation study in 76 canines, in which bone healing was faster and mechanical properties were comparable to Titanium controls. Using healing data, performance observations, and absorption rate data from this study, hardware is being designed for a smaller and simpler BioMg Midface Fixation System which will be the subject of the proposed project. The project plan includes combining data from mandible and midface studies to earn FDA Investigational Device Exemption (IDE) approval. In order to obtain IDE approval, the key Research Plan activities in this project, coming from extensive dialogue with the FDA, are: a. Screw and plate mechanical and absorption design with BioMg 250 thermomechanical processing development to maximize performance b. Complete organ, blood, and urine analyses for mandible preclinical to support systemic toxicity c. New CMF midface safety and efficacy pre-clinical trial through full absorption d. Absorption mechanism analyses of the new midface pre-clinical trial e. Supply chain development through packaging and sterilization of devices f. Test method development and validation for benchtop absorption/corrosion As to the Commercialization Plan, this project will leverage the mandible study to support design and development activities leading up to FDA IDE approval of the BioMg Midface Fixation System. The plan is led by an experienced management team of entrepreneurs and backed by a) academic leaders in orthopedic medicine and engineering from University of Pittsburgh, The University of Michigan, and Michigan State University, b) Contract Research Organizations with GLP laboratories, c) individuals, both internal and external, with medical device approval experience. CMF device manufacturers will oversee and support the project with consulting and provision of commercial devices as control samples.
BioMG 250, a bioabsorbable Magnesium alloy, has been invented by nanoMag to obviate the painful and costly hardware removal operations that are often needed for permanent implants. Following nanoMAG?s promising in-vivo ? NIH sponsored - campaign in a craniomaxillofacial canine model, a pre- clinical midface study is designed to respond to the FDA request for complete absorption along with organ analyses. nanoMAG?s Commercialization Plan for the BioMg Midface Fixation System will be augmented by BioMg 250?s development under FDA compliant Quality Management System control, in collaboration with leading US biomedical companies and Orthopedic Surgeons ? to enable application for FDA Investigational Device Exemption approval and to establish the mechanism to market. (3 sentences)