Neurotech International Limited announced that it has received notification from the Australian Government's Therapeutic Goods Administration (TGA) of the cancellation of the device from entry on the Australian Register of Therapeutic Goods (ARTG or Register) under the Therapeutic Goods Act 1989 (Act), effective on 24 February 2020. The TGA's decision follows a process whereby in response to a broad review of products with claims relating to bioresonance and bio-feedback, the Company in early 2019 and in December 2019 supplied extensive information in response to the TGA's requests, but has been unable to satisfy the TGA that the device complies with all 'Essential Principles' under the Act and the Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations). Specifically, the TGA has informed Neurotech that the information and clinical evidence supplied by the Company with respect to the device, including excerpts of the clinical trial (The Treatment of Autism Spectrum Disorder With Auditory Neurofeedback: A Randomized Placebo Controlled Trial Using the Mente Autism Device - carried out by the Carrick Institute) has not been sufficient to substantiate compliance with the Regulations. The Company has not received reports from the TGA in terms of adverse effects and does not consider that the cancellation amounts to a determination by the TGA that Mente is inherently unsafe to use.