PainChek (ASX:PCK): Investors dreamed 2025 would be the year it finally enters the US market, and their dreams are becoming a reality!

PainChek (ASX:PCK) has among the most admirable medical technologies there is, in the form of an app that can detect pain in non-verbal patients.

Unfortunately, there has been pain for investors along the way. When it was announced that it was participating in a clinical trial the Morrison government was investing $5m in back in 2019, investors would have thought it’d be a tens of millions of dollar revenue business by now. This hasn’t come to pass. Adding insult to injury, companies like ResApp (ASX:RAP) were able to make progress – the latter company was bought by Pfizer.

But now, PCK is valued higher than ResApp was – albeit only just. Moreover, 2025 will go down in the history books the year the company gained FDA approval and thus an entry path into the US market, a far bigger market opportunity than any of the other markets the company is in.

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PainChek’s journey to date

PainChek was founded in 2010, listed on the ASX in 2012 and was renamed PainChek to mirror its primary product in January 2018. PainChek was initially developed to help patients with dementia. Even if these patients can communicate with their carers, they have difficulty describing where the pain is and its extent. However, the app can essentially be used by anyone. Children too young to communicate linguistically, for example, have emerged as another potential class of patients. The company’s aim is not to change clinical assessments, but rather to improve them.

In early 2018, PainChek barely had a working prototype of its app, but it ha taken a long time to progress. After seeking to enter the US, it canned those plans temporarily after receiving FDA guidance that it would need a clinical trial. And so it rolled out in Australia, Europe and Asia.

In Australia, a 2019 decision by the then Morrison government to invest $5m in a clinical trial using PainChek sent shares surging. By June 2021, the company hit its milestone of 127,000 licensed Residential Aged Care beds in Australia utilising its technology. This means that it achieved 60% market penetration in Australia in just a few short years. CE Mark and TGA clearance was achieved in 2021.

By the middle of 2025, the company had conducted over 12m pain assessments and had 110,000 licenses, equating to over 1,900 aged care facilities – with these 3 figures having grown by 6m, 20,000 and 300 respectively in the prior 12 months. However, this has not translated into the revenue that investors arguably would’ve expected from these figures – $3.5m in customer receipts FY25.

Now eyeing off the US

We long anticipated that the company just might realise the anticipated revenue potential if it can enter the USA. There are 2m residential care beds there. Having previously passed on the chance to do a clinical trial there (on 105 patients), PainChek did a trial and having completed it successfully, anticipated finalising an FDA submission in November 2024. FDA applications typically take 150 days. So ideally, it would’ve been done in the first half of 2025.

In April 2025, PainChek advised investors it was required to give ‘additional information for clarification’. Such a meeting was held. Two further meetings were held in May and June. Despite the company saying it was,’ A positive two-way conversation providing feedback and clarity for both parties’, it was,’ compiling additional information collected from the completed clinical study that addresses the FDA feedback and aligns with the agreed actions concluded during the meeting’.

The company expects to submit prior to the end of June, and it expects clearance within 75 days which would be mid to late September. Despite the company telling investors it expected this, and it taken steps like recruiting a local Head of Business Development and establishing integration and reseller agreements, shares fell because investors hate it when companies miss timelines. If Cyclopharm (ASX:CYC) is any guide, all will be forgiven if this timeline sticks. But that is still an if right now.

With a patent lasting until 2038 and existing interest from potential distribution partners, PainChek anticipates it is well placed. Based on projected US pricing, there is a potential gross annual recurring revenue value of US$85m.

The dream is a reality

Ultimately, a submission to the US regulator was made in July. And today (October 8, 2025), the green light was given. So now, PainChek is the first and only regulated medical device for pain assessment in the US. Indeed, an entirely new FDA product code was created (SGB) because this device is the first of its kind. Investors were again told there was a market worth over US$100m annually and that sales would commence shortly.

Shares only moved up 10%, arguably because this news was priced in. But the company achieved a milestone, in surpassing the market capitalisation of ResApp when it was bought out. Clearly, the sky is the limit if the company can make inroads in the US market. PCK has told investors that this approval could streamline approvals in markets including Brazil and the UAE.

Conclusion

Although the company has a unique technology, whether it realises the ambitions investors have dreamed of realising for so many years, was all up to the FDA. And now the green light has been given. So now, the sky is the limit for this company if all goes well.