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- Allegra (AMT) submits a 501K application to the US Food and Drug Administration (FDA) for its Sr–HT–Gahnite spinal cage device
- The submission follows the completion of a range of studies, including a recently completed large animal trial with the South Australian Health and Medical Research Institute
- AMT says the studies prove the product’s mechanical strength, physical properties, safety, and efficacy in cervical fusion
- Following its submission, the company anticipates feedback from the FDA within a 90-day review period
- AMT shares are trading at 5.5 cents at market close
Allegra (AMT) has submitted a 501K application to the US Food and Drug Administration (FDA) for its Sr–HT–Gahnite spinal cage device.
The FDA submission follows the completion of a range of “successful” study outcomes, including extensive laboratory and pre-clinical investigations involving animal testing.
Mostly recently, AMT completed a large animal study with the South Australian Health and Medical Research Institute, which proven the device’s efficacy in cervical fusion through positive mechanical strength and product safety.
Allegra said the FDA milestone marked nine years of “innovation activities”, which began in 2014.
Subject to FDA approval, the company said it was “excited” to bring its 3D-printed bioceramic spinal fusion cage to the market.
“This submission could not have been achieved without our committed team of engineers diligently working on this project to achieve this crucial milestone,” AMT Chief Executive Jenny Swain said.
Following its submission, the company will await feedback from the FDA within a 90-day review period.
Allegra is the sole proprietor of the Sr-HT-Gahnite device and aims to apply the technology to fulfil unmet needs across areas of the body, including the spine, hip, and knee extremities.
AMT shares were trading at 5.5 cents at market close.
