- Autism treatment company Neurotech International (NTI) has had its flagship device cancelled from the Australian Registry of Therapeutic Goods
- The device, called Mente Autism, was cancelled after failing a review by the Therapeutic Goods Administration
- Now that it has been cancelled, the product can no longer be sold as a medical device anywhere in Australia
- Importantly, Neurotech said the safety of the device did not play a role in its cancellation
- Moving ahead, Neurotech will now focus more on European and U.S. markets for the product
- Shareholders responded poorly to today’s news, with shares currently down over 20 per cent and worth just 1.4 cents
Autism treatment specialist Neurotech International (NTI) has nosedived today after its flagship device was cancelled from the Australian Registry of Therapeutic Goods (ARTG).
The Therapeutic Goods Administration (TGA) cancelled the Mente Autism device after a broad review of products relating to bioresonance and bio-feedback.
What is Mente?
The Mente device is a portable headband that helps children with autism self-regulate, relax, and focus. According to Neutotech, the product works by rebalancing excessive activation of low and high-frequency brainwaves, which can often lead to inattention, anxiety, and hyperactivity.
Through audio feedback, the product claims to be able to guide the brain into a more relaxed state. It was this type of bio-feedback tech that brought the product, among others, under scrutiny by the TGA.
Not up to scratch, but not unsafe
Neurotech said in response to the TGA review of bio-feedback products, the company got to work supplying “extensive information” in response to the government organisation’s requests.
This information included excerpts from a clinical trial Neutotech undertook for the Mente product.
Despite the company’s best efforts, however, Neurotech was not able to satisfy the TGA. The company said the device did not comply with all “Essential Principles” necessary for the TGA to give the product the green light.
Importantly, though, Neutorech told investors the cancellation is not due to the safety of the device.
“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,” Neurotech said in an announcement to the ASX today.
What next for Neurotech?
Essentially, the cancellation of Mente from the ARTG means the product can no longer be sold or supplied as a medical device in Australia.
This, of course, cuts out an important and large market for the WA-based company.
However, Neurotech insists the European Union — which is unaffected by the TGA cancellation — is currently the primary market for Mente. The device retained its CE Medical Marking after passing a surveillance audit in the EU. On top of this, the company is seeking market opportunity in the U.S.
In fact, Neurotech management said the removal from the ARTG will not have any material effect on the company’s revenue and current operations. The company said only a “very limited” number of Mente devices have currently been sold in Australia.
Nevertheless, Neurotech said it will need to reconsider its approach for marketing the device in Australia.
The market has taken poorly to today’s news, however, with Neurotech shares crashing in early trade and staying down.
As the market nears its close, shares in the small-cap medi-tech company are down 22.22 per cent and worth 1.4 cents each. Neurotech has a market cap valuation of just $1.9 million.