Ann: Clinical Trial Publication Provisionally Accepted, page-41

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These partnerships are all the more valuable since the company received the required certifications to legitimise the device, and put it on health professionals’ radars. This included the CE Mark in Europe for its latest device which was received in early June 2018, TGA approval in Australia and ISO certification. The missing piece of this puzzle is the full data from the clinical results which has been provisionally accepted by a leading medical journal and now awaiting publication...

Neurotech International (ASX:NTI) is a leading edge medical device company that through its wholly owned subsidiary, AAT Research Limited, has developed the first and only regulated medical device for the management of autism in a home setting.

Clinical trial abstract paint a pretty picture

Yesterday NTI announced that the abstract of the US clinical trial results had been published by Frontiers in Neurology, one of the world’s leading and most cited medical journals.
Frontiers in Neurology has advised that it has provisionally accepted the clinical trial article, “The Treatment of Autism Spectrum Disorder with Auditory Neurofeedback: A randomized Placebo Controlled Trial Using the MENTE Autism Device”, for publication.
Publication of the abstract follows the very encouraging preliminary results released last year from the independent clinical trial of the Mente device undertaken by the US-based Carrick Institute...
The principal trial investigator is Professor Fredrick Carrick who is also a Senior Research Fellow of BCMHR in association with the University of Cambridge, UK and a Faculty Scholar at Harvard Medical School’s Harvard Macy Institute.
For the study, children with a documented diagnosis of ASD were divided into two groups. One group received treatment via the Mente device, while the other group received a placebo.
It was designed as a double-blind study that let the professors running the trial to conclude that:
“Our results show that a short 12 week course of NFB [neurofeedback] using the Mente Autism device can lead to significant changes in brain activity (qEEG), sensorimotor behaviour (posturography), and behaviour (standardized questionnaires) in ASD children... Similar changes were not detected in the Control group.” (Carrick et al. 2018[1])

Next generation Mente autism device due out soon

Whilst Neurotech is awaiting the full data from the clinical trial, it has been undertaking design improvements to the next batch of Mente Autism devices. This includes improvements to wi-fi connectivity, synchronisation and usability improvements linked to the firmware and the Mente Autism application. In early June 2018 the Company received CE approval for this new batch with production now underway. The updated iteration of the device is expected to be available to ship to customers in early H2 CY2018.