More pain, more gain: The summit’s in sight for PainChek on the tougher climb to the US market

• The US Food and Drug Administration next week should clear PainChek’s pain detection app for the US aged-care sector
• Painchek made its FDA entreaty under the harder, more exclusive De Novo (new device) route
• The entreaty opens the way to an addressable market of close to $600 million a year

Just as there are hard and easy ways to climb Mount Everest, PainChek (ASX:PCK) has taken the ‘more pain, more gain’ approach to winning US clearance for its eponymous digital pain assessment app.

Barring any last-minute hiccoughs, the US Food & Drug Administration (FDA) should clear the device, in line with its self-imposed timeline of October 6 (next Tuesday Sydney time).

“There’s nothing we can see that will slow us down for clearance by that date,” says PainChek CEO Phil Daffas.

“However, we are not there yet.”

PainChek is the world’s first artificial intelligence driven digital app to detect and measure pain suffered by nursing homes residents unable to enunciate their discomfort.

For Daffas, a positive decision will culminate an exhaustive, pandemic-interrupted process that began five years ago.

“We first met the FDA for a meeting in June 2019,” he says. “It’s been a lengthy process, but the agency has been very supportive along the way.”

Despite the turmoil engulfing the FDA, PainChek’s review team largely has been unchanged over the five years.

Doing the FDA the hard way

Just as grizzled mountaineers tackle Everest the hard way, the FDA required PainChek to take the more elongated route of a De Novo (new device) application.

Most device makers take the 510(k) route – the equivalent of Everest’s southeast face now attempted by a conga line of climbers, many of dubious ability.

Under 510(k), the applicant needs only to prove ‘substantial equivalence’ to an existing device.

As its name suggests, De Novo means new and novel.

“510(k) approval means you are just another product in the market,” Daffas says.

“US regulators like 510(k)s, because they bring in more competition and lower prices.

“But De Novo is a new standard, a new category, a new ‘everything’. We will be unique, in a significant market with no competition.”

PainChek’s reward is access to an initial US market of  more than three million long-term aged care beds – an addressable market of more than US$100 million ($150) per annum.

With predicate device status, PainChek can expand its indications to hospitals and home care. This balloons the addressable market to $A580 million.

Giving voice to the silent sufferers

The algorithm and AI-based device gives a  voice to people who cannot reliably verbalise their pain (notably people with dementia).

The process involves the carer capturing a three-second image of the resident’s face. This detects the presence of up to nine facial pain expressions.

Combined with other clinical resident observations, the tool produces an overall pain score and severity rating.

To date carers have used manual subjective processes such as the Abbey Pain Scale. Think of PainChek as the equivalent of replacing an old mercury thermometer with a digital one.

The Australian Therapeutic Goods Administration (TGA) and the European device gatekeeper cleared PainChek in 2017.

To date, nursing homes have recorded around 12 million pain assessments with the tool.

“They can track pain management across all of their facilities and use it for auditing and accreditation purposes,” Daffas says.

More on schedule than a Swiss railway

PainChek is quietly confident of a positive FDA decision, partly because the parties liaised closely every step of the way.

To support its entreaty, PainChek carried out a study of 105 nursing home residents, across five sites in Iowa and New York.

The results confirmed the device’s accuracy in detecting no pain as well as low, moderate and severe pain.

“We achieved the endpoints that we agreed to with FDA a year previously,” Daffas says.

“That’s why it took so long.

“You can either do a study you think will be acceptable and submit it, or work with the FDA to agree on the endpoints upfront.”

No prizes in guessing what approach results in unpleasant surprises.

Daffas says PainChek has emerged from the process with a more robust product and delivery process.

He adds the US government shutdown should not affect the timeline. That’s because FDA applications are a revenue-generating, fee-for-service process and thus are exempt from closure.

Bedding down global expansion

As of June 2025, PainChek has achieved licences for 110,000 beds, across 1900 nursing homes in Australia, New Zealand, Canada and the UK.

Of these, the company has implemented 71,000, equating to annualised recurring revenue of $5.4 million.

The company already has a decent foothold in the Australian aged care sector, claiming a circa 35% market share: 75,000 licences across 200,000 beds.

Local users include Baptistcare, Bolton Clarke, Ozcare and Anglicare

The company claims coverage of 40,000 of the UK’s 440,000 beds (9% penetration).

Locally the nursing home clients pay a subscription of $50 per bed per year, with an equivalent fee of £30 per annum in the UK.

Pending FDA clearance, PainChek has lined up its maiden US client (albeit a small one).

“We believe we will get a premium price in the US,” Daffas says.

No time to admire the view

Having reached the FDA ‘summit’, management won’t admire the view for too long before it launches its commercial phase.

As well as building its own US sales team PainChek has an integration partnership with long-term care supplier Point Click Care, covering more than one million US beds.

A care-management provider, Point Click Care documents patient records and information.

PainChek also has an integration and reseller tie-up with Elder Mark, which will sell the device alongside other products.

Elder Mark has a customer base of up to 400,000 beds in the US and Canada.

In rarefied company

De Novo clearance will put PainChek in rarefied company as one of only a few device plays to achieve this status.

Daffas says in the neurology field, the FDA cleared nine de novo devices in 2024. So far this year it has greenlit only one that includes AI or machine learning.

“In comparison there are hundreds of 510(k) clearances annually,” Daffas says.

“De Novo applications are more complex and take longer, but then you are in a category of your own.”

In July the company raised $7.5 million in a placement: enough to fund the US rollout.

So just as a good mountaineer needs high-quality pitons and crampons, PainChek is well equipped for the task financially.

At Stockhead, we tell it as it is. While PainChek is a Stockhead advertiser, the company did not sponsor this article.