Companies:

 

Articles:

 
Technology

PainChek prepares FDA De Novo submission for smartphone app following successful US clinical study

Go to Imelda Cotton author's page
By Imelda Cotton - 
PainChek ASX PCK FDA De Novo submission
Copied

PainChek (ASX: PCK) has announced positive outcomes from a US clinical validation study that will allow the company to progress with a Food and Drug Administration (FDA) De Novo submission for its Adult smartphone app.

The study recruited 105 nursing home residents at five sites in Iowa and New York, who were assessed for pain in a comparative study with the Abbey Pain Scale measuring pain in patients unable to clearly articulate their needs due to dementia, cognitive or communication issues.

Preliminary results and statistical analysis were found to be consistent with previous observational pain tool studies.

FDA submission

PainChek will now submit the results of the validation data along with other documentation, such as US cybersecurity and software paperwork and device labelling requirements, to the FDA for De Novo regulatory clearance.

The company expects to complete the submission in November, after which it will be subject to the FDA’s review period of around 150 days.

PainChek also plans to submit the validation data for peer-reviewed journal publication and for presentation at US medical conferences as part of its US market entry strategy.

Aged care market

PainChek chief executive officer Philip Daffas said FDA approval would help the company address the massive US aged care market, where 1.7 million people reside in long-term care facilities, generating a potential gross annual recurring revenue for PainChek’s app of around US$85 million.

“Should PainChek Adult obtain FDA clearance, it would become the first approved pain assessment tool in the US specifically designed for aged care residents with moderate to severe dementia who are unable to self-report their pain,” Mr Daffas added.

“This clearance would also provide an important predicate for the PainChek Infant app and support the expansion of PainChek Adult into larger markets such as home care and hospitals.”

PainChek is well-placed to penetrate the North American market given existing partnerships with companies such as PointClickCare, which provide integration access to over 1 million aged care beds across the US and Canada.

Pain assessment

The PainChek app is available on smartphones and tablets and combines an artificial intelligence pain assessment tool with the numerical rating scale to allow accurate and consistent pain assessment for patients living with reduced ability to self-report pain.

The device has attained regulatory clearance in Australia, Canada, the European Union, New Zealand, Singapore, Malaysia and the UK.

PainChek is used by more than 1,600 aged care facilities worldwide and has recorded more than 7 million digital pain assessments to date by nurses, carers and clinicians.