Allegra Orthopaedics Limited (ASX: AMT) is moving ahead with development of its new Spinal Cage design after achieving promising results through testing in the USA.
The Sr–HT–Gahnite Spinal Cage Device, Allegra’s flagship innovation project, was recently successfully bench tested at the Kolling institute.
Subsequently, the company engaged an accredited testing facility in the USA to confirm the effectiveness of the revised Spinal Cage design, with the results showing a significant improvement in strength when compared to the previous design.
More specifically, the compressive strength of the Spinal Cage was 60kN. This is significantly above human physiological load (1.2kN) and sheep physiological load (3-4kN).
It is also double the compressive strength when compared with the previous cage design and above the 95th percentile for published data on FDA approved cages.
These results are complemented by improved torsional and shear compressive strengths, as well as mechanical integrity of the cage demonstrated in sheep cadaveric testing.
Notably, the same facility conducted dynamic compressive testing to determine the fatigue life of the Spinal Cage. We are very pleased to report it passed the regulatory-required five million dynamic cycles without any signs of fracture or failure.
Due to these positive results, Allegra is progressing with the new Spinal Cage design and plans to commence a pilot animal study in January 2021 within Australia. This will be a confirmatory study to be followed by a large animal study, as per FDA requirements.