Yesterday I received an email from the University of Wollongong with the following media release about the ePAT App has now received regulatory clearance in Australia and for the European Economic Area (EAA). Below is the announcement that was placed on the ASX yesterday.
As one of more than 50 million people living with dementia in the world, and for anyone with communication disabilities from dementia or not, I really hope it works. As with every new drug, App or tool used in health (or anywhere), only time will tell…
Please note: adding this media release, does not mean I endorse the product, nor is it a recommendation to purchase shares.
Media Release 19th July 2017
ePAT Pain assessment App secures regulatory clearance
- ePAT App is now cleared for use as a medical device in Australia (TGA) and CE marked for European markets
- Regulatory clearance is a key business milestone and requirement by the ePAT customer base
- Australian Commercialisation of the ePAT App remains on schedule for Q4 2017 and Europe during 2018
The ePAT pain assessment App has been CE marked and is included on the TGA Australian Register of Therapeutic Goods (ARTG) as a Class 1 medical device.
The ePAT App’s intended use is “to assess and monitor pain in people who cannot verbalise such as people with dementia or communication difficulties”
Company CEO Philip Daffas said he was delighted the ePAT App now meets the regulatory requirements that enable it to be promoted in these key international markets.
“This is a critical milestone in the commercialization of the ePAT App. We are now in a position to implement our commercialisation plans in the final quarter of 2017 as we had originally planned,” said Daffas.
The ARTG inclusion and CE marking are essential for medical device products to be launched in Australia and the European Economic Area (EEA).
This provides ePAT with market access to two large geographies which combined represent more than 30% of ePAT’s initial global market opportunity.
“Our healthcare professional customers and consumers will look for ARTG inclusions (TGA clearance) and CE marking on our App to confirm that the organisation has taken the required steps to confirm the performance and safety of the ePAT App,” added Daffas. “Our commercial model will be based on a subscription model that fits with the needs of the Enterprise market, i.e. the carers in aged care centers, and carers for home use. We believe this will allow for rapid take up and provide a solid base for the long term business”
In addition, being a Class 1 medical device differentiates the ePAT App from the multitude of “wellness” apps on the market that typically have not gone through the regulatory process and are not recognized as medical devices.
ePAT has a defined commercialisation strategy that will see it generate recurring revenues from a range of revenue sources. Primarily it plans to sell via a Software as a service (SaaS) model, whereby it will sell via software enterprise partners and direct to business. It will also sell its product direct to consumers via the App Store and Google Play.
ePAT Technologies Limited is an Australian based company which is developing mobile medical applications that are intended to provide pain assessment for individuals that are unable to communicate verbally with their carers.
The ePAT business:
The ePAT business has evolved from research undertaken by Curtin University in Western Australia over the past 3 years. ePAT now owns the intellectual property resulting from Curtin University’s research on the ePAT Apps.
ePAT’s technology, a mobile application (ePAT App), uses cameras in smartphones and tablets to capture a brief video of the person, which is analysed in real time using facial recognition software to detect the presence of facial micro- expressions that are indicative of the presence of pain. This data is then combined with other indicators of pain, such as vocalisations, behaviours and movements captured through the ePAT App to calculate a pain severity score.
Due to its ease of use and its reproducibility, it is intended that the ePAT App will be able to be used in the first instance to detect and measure a person’s pain, and then further measurements can be used to monitor the effectiveness of pain management provided to the person.
The ePAT App is being developed and will be rolled out globally in two phases: first, the ePAT App for Dementia for persons who have lost the ability to communicate with their carers, and the second, the ePAT App for Children who have not yet learnt to speak.
For further information, please contact:
Ian Hobson Philip Daffas
Company Secretary Managing Director
Tel: +61 8 9388 8290 Tel: +61 406 537 235