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- Allegra Orthopaedics (AMT) has completed its eight-week timeline for a large animal pilot study performed at the South Australian Health and Medical Research Institute (SAHMRI)
- CT imaging taken at intervals throughout the study confirmed the spinal cage was performing as intended, with complete fusion in both lumbar and cervical zones
- Allegra says it will now aim to reproduce these outcomes in a six-month-long, large-animal trial in Australia
- The company’s aim is to obtain approval from the Federal Drug Administration (FDA) in the United States by November 2021
- Allegra Orthopaedics is in the grey, last trading at 34 cents
Allegra Orthopaedics (AMT) has completed its eight-week timeline for the large-animal pilot study performed at the South Australian Health and Medical Research Institute (SAHMRI).
Allegra Orthopaedics is the sole proprietor of the strontium-gahnite material and aims to apply its technology for spines, hips, knees and other extremities.
CT imaging taken at intervals throughout the study demonstrated stable implants with complete fusion in both lumbar and cervical zones, confirming the spinal cage performs as intended.
This completion comes after the December 2020 announcement of its dynamic torsion, compression and shear tests passing the regulation five million cycles without any signs of fracture or failure.
Allegra says it will now aim to reproduce these outcomes in a six-month-long, large-animal trial in Australia, with the aim to obtain approval from the Federal Drug Administration (FDA) in the United States by November 2021.
The company says the results of the eight-week animal study mark a pivotal milestone for Allegra and a confirm a viable pathway to obtaining a 90-day FDA clearance in the near future.
“Demonstrating both fusion and stability of a spinal cage made of an alternative material to those currently available in the market such as metal or peek is an exciting milestone,” said Dr Nick Hartnell, Director and medical advisor to Allegra.
“It also demonstrates just one of a multitude of applications for the Sr-HTGahnite technology. I look forward to seeing the positive results from the pilot study duplicated in the large animal study over the next 6 months and the subsequent applications to the TGA and FDA.”
Allegra is now in the process of entering its final validation and verification testing of the spinal cage.
Allegra Orthopaedics is in the grey, last trading at 34 cents at 3:50 pm AEST.
