The FDA has asked for more supporting information and the biotech’s directors have decided it’s all too expensive.
Biotech Allegra Medical Technologies has withdrawn its submission to the FDA regarding its 3D-printed Sr–HT–Gahnite spinal cage orthopaedic device after the US regulator requested additional supporting information.
An announcement from AMT said:
“Given Allegra’s limited working capital and the additional expense now required in obtaining supporting data for the company’s submission to the FDA, the Directors have now thoroughly explored all available options.
“After careful consideration, the preferred option is to go to the market to seek a buyer for all of the intellectual property relating to the Sr-HT-Gahnite and Sr-HT, including worldwide patents and all registered patents and application for patents in relation to the bio ceramic material, including the spinal fusion cage.
“The Company confirms that in undertaking taking this process any proposed sale will be subject to the required ASX and regulatory approvals.”
The Sr-HT bio ceramic material began development in 2010 at the University of Sydney. Subsequently, Sr-HT-Gahnite was developed, featuring bioactivity, biocompatibility and mechanical properties “suitable for load-bearing orthopaedic implants”, according to the company.
The spinal cage was hoped to be used as a cervical fusion cage in spinal surgeries, “offering safe and effective treatment options for patients”.
The withdrawal of the FDA submission is considered a major blow for Allegra.