Pictured: Allegra Orthopaedics CEO Jenny Swain, MTPConnect Chair Sue MacLeman and MTAA CEO Ian Burgess in April 2018 at the launch of BioMedTech Horizons in Melbourne.
Project title: B3D Cervical Interbody Fusion Device
The Allegra Orthopaedics fully synthetic spinal cage works to regenerate bone under spinal load conditions and be completely resorbed by the body, leaving it and the intervertebral space free of foreign materials – making it a one-of-a-kind innovation.
The device is 3D-printed from a synthetic bone bioceramic (Sr-HT-Gahnite) invented at The University of Sydney. The synthetic bone possesses the mechanical strength required for load-bearing conditions, bioactivity needed for outstanding bone regeneration, and resorbability that reduces the risk of rejection and infection – all in a customisable structure. No bone graft is required as the device material induces bone graft. This project will provide the necessary funding for device production for preclinical testing.
BMTH Round: One
- Lead: Allegra Orthopaedics
- Partners: University of Sydney, University of Wollongong, Boron Molecular & Sabre Medical
- MTPConnect grant: $1,141,500
- Industry contribution: $4,953,165
Duration: May 2018 - July 2021
Outcomes: Allegra has achieved ISO 13485 certification and can now be the legal manufacturer of the spinal cages. The team has also determined the packaging and sterilisation method for the product and confirmed optimal storge conditions and a five-year shelf life. The final pilot study was successful with all implanted cages demonstrating complete fusion at the implanted sights.
Contact: Ameneh Sadeghpour, Innovation, Quality & Regulatory Affairs Manager