# Commercialization Readiness Program (CRP) for Bioabsorbable Magnesium (Mg) Implants for Craniomaxillofacial Surgical Systems

> **NIH NIH R44** · NANOMAG, LLC · 2020 · $2,260,835

## Abstract

NIH 19-333 – Project Summary
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.

## Key facts

- **NIH application ID:** 10079889
- **Project number:** 2R44DE024919-04
- **Recipient organization:** NANOMAG, LLC
- **Principal Investigator:** Stephen LeBeau
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,260,835
- **Award type:** 2
- **Project period:** 2015-06-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10079889

## Citation

> US National Institutes of Health, RePORTER application 10079889, Commercialization Readiness Program (CRP) for Bioabsorbable Magnesium (Mg) Implants for Craniomaxillofacial Surgical Systems (2R44DE024919-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10079889. Licensed CC0.

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