Not sure this will have to go through phase 1, 2, 3 like a pharma does?
Currently proof of concept - done - and it works. They would likely be able to go straight into a larger confirmation trial.
BTM was able to get TGA and a FDA 510k approval after a free flap donor site trial and a 5 person large TBSA burn trial (obviously with many animal trials prior to these).
Ann: BTM delivers positive First in Man results in Cell Therapies, page-71
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