Introduction - nanoMAG LLC, an engineered biomaterials manufacturer, is developing and commercializing next generation, magnesium (Mg) biocompatible materials with applications in craniofacial and orthopaedic medicine. The overall goal of this SBIR Fast Track project is to develop a bioabsorbable Mg implant for mechanical fixation in craniofacial surgical procedures. This will include confirming function and biocompability, followed by large animal studies required both by FDA and OEM device manufacturers to advance the commercialization of these devices. Significance - Commercial bioabsorbable polymer alloys exist; but they are not strong enough for load bearing and rigid fixation applications (they are FDA approved for only non-load bearing applications). Non- bioabsorbable titanium (Ti) and stainless steel are also used in craniofacial procedures; but complications can occur that necessitate a secondary surgery to remove the devices. Surgical removal is advocated in 60% of cases involving young patients (1). Removal of Ti implants can be extremely difficult, threatened by screw- head fracture, nerve damage, infection and bone refracture (1,2,3,4,5,6). There is a critical need for stronger bioabsorbable materials for craniofacial devices. Long Term Goal and Relevance to NIDCR mission - BioMg 250 will enable rigid craniofacial fixations while obviating the pain, cost, stress and infection risk of secondary operations. The Product - nanoMAG's products are bone fixation devices (plates, screws, tubing) produced from bioabsorbable Mg based alloy, BioMg 250, for use in craniofacial devices. Phase I Hypothesis and Specific Aims - An experimental methodology and protocol for functional evaluation of BioMg 250 can be developed based on a pilot animal study. A mandible fracture model pilot animal study in swine will demonstrate the feasibility of the technology, providing fully documented protocol and procedures developed for General Laboratory Procedure (GLP) animal studies to be carried out in Phase II. Phase II Hypothesis and Specific Aims - GLP Large animal craniofacial implant studies in conjunction with biocompatibility testing will demonstrate the efficacy and safety of bioabsorbable BioMg 250 implants for load bearing devices. Expected outcomes - carefully executed and fully documented pre-clinical large animal studies to support submission of data to FDA regulatory examiners as well as to OEM strategic partners. .
Relevance ? This project is relevant to the NIDCR Research Topic of development of materials and devices for craniofacial reconstruction. Specifically it is focused on craniofacial bone fixation. As to public health, the target is to save patients from the cost, pain, stress and infection risk of secondary implant removal surgeries.