TGA and EU approval for the ePAT pain assessment App as a Class 1 medical device.
The ePAT App’s is approved for use “to assess and monitor pain in people who cannot verbalise such as people with dementia or communication difficulties.”
CEO Philip Daffas said he was delighted the ePAT App now meets the regulatory requirements that enable it to be promoted in 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 TGA approval and CE marking are essential for medical device products to be launched in Australia and the European Economic Area (EEA).
“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,” said 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”
The company said approval as 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 recognised as medical devices.
ePAT will primarily be sold via a Software as a service (SaaS) model, under which 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.