PainChek to secure FDA De Novo classification

Formerly ePat Technologies (ASX: EPT), medical device company PainChek (ASX: PCK) is on course to secure De Novo classification from the Food and Drug Administration (FDA) in the US ­— a relatively new process for novel devices which have not previously been classified.

The ASX-listed company has developed an app which it claims detects pain simply from analysing facial micro-expressions. The mobile phone app automatically detects pain through facial recognition technology and liaises with other digital tools to update patient records and care management resources.

According to PainChek, it’s app is the world’s first smartphone pain assessment and monitoring device which is primarily designed to assist care workers and nurses with objectively identifying pain symptoms among people who are unable to communicate such as dementia sufferers or pre-verbal children.

According to the World Health Organisation, there are an estimated 150 million carers for people with dementia globally.

Pain often goes unrecognised and under-treated in people with communication difficulties such as dementia. Although tools exist to assess pain, they are often subjective, manually based and subsequently underused by carers.

PainChek intends to commercialise this gap in the market with its secure smartphone-based medical device that uses artificial intelligence to assess and score pain levels in real time and update medical records in the cloud.

Regulator-approved commercial path

PainChek has already obtained regulatory clearance in Australia and Europe but hopes to add US permissions to its portfolio in order to access the largest healthcare market in the world and present its product in front of millions of potential users.

“We are pleased with this preliminary response as the FDA recognises PainChek as a novel medical device and we have experience of this process. The added benefits of conducting clinical trials in the US, prior to commercial launch, includes engaging with major potential clients at an early stage that can accelerate the overall market development in the USA,” said Mr Philip Daffas, chief executive officer of PainChek.

The PainChek app has TGA and CE Mark clearance thereby providing access to more than 40% of the global market including Europe and Australia, which means the company’s commercial focus will remain trained on Australia and the EU until the FDA gives the green light for PainChek to be used in the US.

So far, the FDA has advised PainChek that it will have to provide clinical performance data to support its pre-market submission. As part of its discussions with the US regulator, PainChek said that it will provide existing clinical trial results completed outside of the US but warns that additional clinical data may be required for the De Novo submission including a fresh clinical trial in the US.

Several clinical studies conducted in Australian residential aged care centres have been published in the Journal of Alzheimer’s Disease.

The latest published article in June 2017, indicates that PainChek is a valid and reliable pain assessment tool for people with moderate to severe dementia, who can no longer self-report their pain and that it offers significant advantages over the current pain assessment methods.

PainChek’s share price fell more than 7% in late afternoon trade to A$0.065.