Ann: Clinical Trial Publication Provisionally Accepted, page-40

Another article today from Next Biotech:
https://www.nextbiotech.com.au/revolutionary-medtech-device-new-frontier-autism-treatment/



Revolutionary MedTech Device: a New Frontier in Autism Treatment

PUBLISHED: 26-06-2018
Autism, or autism spectrum disorder (ASD), is a developmental disorder that affects approximately 1 in 160 people worldwide, which equates to more than 40 million people globally.
Symptoms typically start in early childhood, and can include difficulties socialising, repetitive or limited patterns of behaviour, and general trouble communicating and they range from mild to extreme.
They can make growing up, and everyday life, particularly challenging for anyone with autism and for kids in particular, as autism can hinder their ability to learn.
A child with ASD may not smile at caregivers, respond to his/her name when called, or make eye contact with other people unless explicitly told to. Using eye contact or gestures to share experiences is called ‘shared attention’ and is an important aspect of learning.
For children with autism, the inability to tune into this experience can set them back and delay their learning. What’s more, problems engaging in ‘shared attention’ can lead to an inability to take turns talking, not being able to interpret another child’s emotions or not being able to ‘stay on topic’. All of which mean that for a child with ASD, a traditional schooling environment can be problematic.
In Australia alone, in 2011 an independent report estimated the annual economic cost of ASD of between $8.1 billion to $11.26 billion highlighting the critical need for new treatment methods and solutions
Which brings us to today’s company that has created the first and only regulated medical device for the management of autism in a home setting which yesterday received some incredible results from its US Clinical trial.
While there’s a long list of testimonials and anecdotal evidence collected by the company, the big fish to catch is a successful fully independent, double blind US based clinical trial and the company yesterday announced that the results from its US clinical trial have been provisionally accepted by leading medical journal, Frontiers in Neurology. Whilst the full article is not yet available, it is expected to be published soon and a full copy of the abstract is available online.
The abstract states:
“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])
These very exciting results noted in the abstract follow the very positive preliminary findings released in September last year, describing the changes observed in autistic children after a 12-week clinical trial as ‘outstanding’ with ‘many of the children scoring in a normal range after the treatment’.
Publication of the full article, including supporting analysis, will be a game changing near term catalyst for NTI which will be immediately followed by a US FDA submission.
The Treatment of Auditory Spectrum Disorder with Neurofeedback: A Randomized Placebo Controlled Trial Using the MENTE Autism Device. Frontiers of Neurology. Provisionally accepted as at June 2018.
Although, we can’t predict what the results will be, so investors should seek professional financial advice for further information if considering this stock for their portfolio.
Meanwhile this $19.6 million capped play has been busy securing distribution partners and readying its sales channels in anticipation of the final results.
Since listing in late 2016, the company has signed distribution partners across Germany, Switzerland, Austria, Greece, Australia, India and the Middle East.