Promoted as Australia’s next health technology unicorn, the startling claims of artificial intelligence start-up Helfie.ai could come unstuck in record time as regulators start taking an interest.
Helfie is promoted by founder George Tomeski – who left a trail of wreckage at former gambling start-up PlayUp – and makes the startling claim that its AI systems can check for tuberculosis, pneumonia, and lung disease, even STIs and skin cancer – all by taking a photo or coughing into your phone.
At $3.50 a pop, any time you’re worried about a mark on your skin, you can just take a picture and “know, instantly”, according to Helfie’s promotional material.
Its Skin AI system, the company claims, has a 91 per cent accuracy rate in spotting photos containing skin, and 96 per cent accuracy in detecting and checking lesions for signs of skin cancer – and a low rate of false positives.
Those are pretty extraordinary claims. But Helfie’s website gives no details of where they come from, or whether they are backed by formal clinical trials.
The app is firmly aimed at home consumers in the US, Australia, Britain, Europe and Africa, according to its corporate marketing material.
And therein lies the problem.
Medical devices are pretty heavily regulated in almost all Western markets. Helfie has a single medical device registration with Australia’s Therapeutic Goods Administration as a Class 1 device – which means it can be used by doctors and specialists as a “diagnostic support tool”, but definitely not marketed to consumers.
In fact, according to the TGA, you can’t market cancer screening or diagnostic devices to the public at all. Same goes for STIs.
Even Helfie’s existing registration runs out at the end of the month, according to the TGA, and its re-registration will be evaluated by the regulator at a “higher risk classification”.
The TGA don’t comment on investigations or enforcement action, but a spokesman confirmed the regulator “is aware of the company and the information on its website and is currently reviewing the website content to identify any information that does not comply with the regulatory requirements”.
You’d think that the company’s board would be aware of these kind of issues, given it includes one-time Moderna chief scientific officer Tony De Fougerolles.
Maybe add that to the other mysteries surrounding Helfie, including where the company’s valuation comes from.
A spokesman for Helfie declined to comment on Tuesday.
Bitcoin smash-up
Who wouldn’t want to watch a pair of bitcoin bros dragged before the courts to face questions about the inner workings of their cryptocurrency business?
That’s the fate facing former Macquarie bankers Dan and Will Roberts, as the Canadian receivers for a pair of their companies try to export a $US100m fight over bitcoin mining computers into the Australian courts.
The pair haven’t had the easiest time over the last few years. The value of shares in their Nasdaq-listed crypto mining company, Iris Energy, has plunged to around $US8 since its $US28 listing in 2021.
The Iris share register has included the likes of Mike Cannon-Brookes’ Grok Ventures, Kerr Neilson’s Platinum Asset Management, Philip King’s Regal Funds Management, Geoff Wilson’s WAM and Alex Waislitz, although it’s now spread thinly over Nasdaq investors.
An attempt to reposition Iris as a high-powered computing company servicing the booming AI bubble led to a brief revival this year, before again crashing to earth in the face of a short-selling attack by Culper Research.
That attack, which argued Iris had “dramatically misrepresented” its computing power amid the pivot to AI (and the company’s poor market performance since listing) has seen Iris spawn its own class action cottage industry in the US – the most advanced of which was tossed out of court this week.
And now the brothers face the unedifying prospect of being dragged before the Australian courts over the bankruptcy of two Canadian companies that bought computing gear using a $US100m loan from US-based crypto funder Nydig.
A quick explanation, perhaps, for those terminally attached to rock stocks and banking dividends: Iris owns computers that run complicated equations that somehow get turned into bitcoin. Bitcoin’s main use for ordinary citizens is to pay off ransomware demands from Russian hacking gangs, although some major banks insist on promoting it as a genuine asset class.
Anyway, in this case, a pair of Iris subsidiaries bought about 36,400 computers using Nydig’s loan and installed them in warehouses in British Columbia, where power is cheap.
Sadly, their installation came just as the bitcoin price crashed and the Canadian companies collapsed.
Enter PwC Canada as receivers, who were horrified to discover that the Nydig loans had no recourse to Iris’s other assets, and set about trying to fix that in the Canadian courts – arguing that Canadian companies had no employees and were selling bitcoin to Iris at less than the cost of production, and Iris should be seen as single corporate entity rather than the 27 separate companies siloed away from each other.
After a rejection in the Canadian courts, the argument now moves closer to home for the Roberts brothers, with PwC believed to be chasing an examination of both before the courts. Iris declined to comment as the matter is before the courts, but a spokesman was happy to point to PwC’s legal losses in Canada as a possible guide to future performance.
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