Medtech player to commercialise device for mental health illnesses – Med-Tech Innovation | Latest news for the medical device industry
Australian medtech company NeuralDx is set to progress the commercialisation of its EVestG device, which supports clinical diagnosis of psychiatric and neurological disorders.
The EVestG device enables clinicians to diagnose such disorders via digital biomarkers – a quick, painless, convenient and minimally invasive objective test of a patient’s neural responses to determine common brain disorders.
Dr Roger Edwards, NeuralDX chief executive officer, said: “A Meta-study of over 50,000 subjects in the UK have shown that doctors get the diagnosis of depression wrong more than 50% of the time, during first few consultations, not because they are incompetent – there just hasn’t been an objective tool like EVestG to assist in diagnosis.”
In some cases associated with bipolar disorder [manic/depression] diagnosis, 69% of sufferers report receiving a misdiagnosis which in some cases can go on for over ten years before being effectively treated.
NeuralDx has spent 12 years developing the technology, which it is on the verge of commercialising in Australia and overseas.
Dr Edwards said: “Mental illness is the number one global health issue costing communities trillions of dollars in treatment, management and lost productivity each year, as well as untold suffering and suicide.
“The existing methodology for diagnosing psychiatric and neurological disorders is largely subjective, lacking accuracy and consistency. With EVestG applied to classifying Major Depression from Bipolar Disorder, a greater than 80% accurate diagnosis will be possible after the first visit to the clinician’s office, rather than days, weeks or months.
“EVestG is to the mind what an electrocardiogram (ECG) is to the heart; a diagnostic tool measuring the neural activity of the brain, but significantly less expensive, more convenient, accurate and versatile than EEG, PET or fMRI scans.”
In other controlled studies of the neural responses of over 600 subjects, EVestG technology has measured and analysed digital biomarkers specifically linked to Concussion, Schizophrenia, Alzheimer’s and Parkinson’s disease.
All these results are published or under-review in more than 15 peer reviewed international journals, and all demonstrate EVestG’s high diagnostic potential.
NeuralDx has already registered three patents for EVestG in Australia, the USA, Canada, Europe, China, India and Japan.
Three EVestG units have been built and tested, with one device currently in operation at the University of Manitoba, Canada.
Dr Edwards added: “Everyone should be worried about the accuracy and speed by which mental illnesses are diagnosed. Sufferers in the 21st Century deserve better than what is currently possible, whether they are undiagnosed or misdiagnosed depressed person suffering in remote Australia, a combat warrior, an airline pilot, emergency services person, or someone in your family.
“An advanced diagnostic test like EVestG is needed globally so those that are suffering can get the right help faster with better health outcomes for all.”
NeuralDx is seeking capital to fund a commercial pre-production EVestG model to seek regulatory approval from the Australian Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA).