Toku Eyes founder Dr Ehsan Vaghefi says his company's AI software can analyse retinal scan images faster than a human clinician and pick up things they might miss - helping to spot conditions such as type 2 diabetes to cardiovascular disease.
Toku Eyes founder Dr Ehsan Vaghefi says his company's AI software can analyse retinal scan images faster than a human clinician and pick up things they might miss - helping to spot conditions such as type 2 diabetes to cardiovascular disease.
An Auckland medtech start-up has won a rare spot on a programme that fast-tracks devices for regulatory approval in the US.
Toku Eyes makes AI-powered software that analyses scans of the back of your eye. Because your eye is transparent, it’s one of the easiest ways to get a pictureof your veins - and changing colour or shape that indicates a heightened risk of type 2 diabetes, a stroke or cardiovascular disease.
On November 2, the US Food and Drug Administration granted “Breakthrough Device” designation to Toku’s CLAIiR (Cardiovascular Risk AI) platform.
Toku Eyes founder Dr Ehsan Vaghefi describes it as a “fast pass” that sees extra FDA resources allocated to accelerating a product’s approval under a scheme that involves just a handful of contenders per year.
Toku Eyes' software uses artificial intelligence to analyse a retinal image (an eye scan) then return a result in around 10 seconds.
Devices are put on the priority-review programme for their potential to offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The Herald understands that Toku Eyes is just the second New Zealand company to be awarded a Breakthrough Device fast-track after gastrointestinal tubing start-up Surgical Design Studio (which, like Toku Eyes, was spun out of Auckland University research) in 2019.
A retinal scan in progress. Toku Eyes' AI software, which sits in the cloud, is designed to be brand, neutral, working with any fundas camera (retina imaging device) that's connected to the internet.
The start-up also revealed this month that it’s been granted a patent in the US for CLAiR (the initials stand for Cardiovascular Risk AI)
Vaghefi pitches Toku Eyes’ platform as a cheaper and easier way to detect cardiovascular disease or type 2 diabetes.
He said a cardiovascular check-up would ordinarily entail a trip to your GP, then a referral to a specialist as you navigate an often jammed health system.
Instead, he sees his start-up’s software working with machines at opticians in malls, helping to democratise testing and make it more affordable.
That vision got a vote of confidence in April this year when Toku Eyes staged a US$8 million ($13m) Series A raise involving two of the biggest players in the US optometry market.
The funding round was led by Nasdaq-listed National Vision (market cap: US$1.3 billion), the second biggest optical retailer in the US, and Japan’s Topcon Healthcare - a Japanese firm that’s one of the world’s largest makers of eye examination instruments.
Seed investor Icehouse Ventures also returned to support the new raise.
Vaghefi says National Vision and Topcon are strategic investors. All going to plan with the FDA fast-track, they will also become Toku’s largest customers after it gains regulatory approval.
Personal quest
For the founder, his quest is personal.
“When I was going to school when I was little, other children would get help crossing the road and I would be helping my father across,” Vaghefi told the Herald.
His dad was just 4 when he went blind as a result of congenital glaucoma - a preventable condition, even then.
Today, type 2 diabetes is the most common cause of blindness or vision impairment in New Zealanders aged 20 to 60.
Some 270,000 Kiwis have been diagnosed with type 2 diabetes, but estimates are that the true number could be 30 to 40 per cent higher.
‘Game changer’
Vaghefi said although he now spends a lot of his time in the US, Toku Eyes will keep its R&D in New Zealand.
He was one of the entrepreneurs on hand when National announced its tech policy at a tech hub in Parnell in September, which featured pledges for thousands more tech visas, and a promise to investigate removing a tax on unrealised gains from employee stock ownership plans (esops).
“That will be a game-changer,” Vaghefi said.
“It’s essential for young companies like ours, we need esops to attract talent. But the law is stacked against them at the moment; they’re a tax liability. The visa changes are good because one of the things that can make or break a young company is access to top-tier talent - someone who’s done it before and been a CEO of a multi-billion company.”
Like everyone else, he’s now waiting to see which policies make the cut in coalition negotiations.
Chris Keall is an Auckland-based member of the Herald’s business team. He joined the Herald in 2018 and is the technology editor and a senior business writer.
