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There are 43 million people in the world who are blind, and another 295 million who have moderate-to-severe visual impairment. The shocking number is how many of those people have a disease that was preventable or treatable: nearly three quarters, meaning there are nearly 300 million people who should have their sight, but don't.
One of the biggest obstacles is access to care, according to Ehsan Vaghefi, co-founder and CEO of Toku Eyes. His own father went blind as a child, spurring him to develop of an artificial intelligence platform for more accurate, and more accessible, healthcare diagnostics through eye scans.
"As I grew up, and learned more, it was interesting that a lot of these diseases of blindness that I see in my friends or their family members are very much preventable. It's just they don't have access to care; most of the time, they don't have access to even the first screening, the first detection," he said in an interview.
"My research has always been about coming up with novel technologies that can enable somebody to have an eye exam, cheaply, affordably, everywhere, so you wouldn't need a clinician, because the clinician is probably the most expensive part of the system."
The Auckland, New Zealand-based Toku Eyes achieves this through its two products: the first one, called THEIA, is an AI platform that can look at the images of the eye, without the need of a clinician, and quickly tell if they need to go and see a clinician. The second product is called ORAiCLE, and it uses AI to recognize minute changes in the blood vessels to capillaries to determine a person’s risk of having a cardiovascular event, such as a stroke or heart attack.
The company, which is currently live in New Zealand and India, and which has been used by one million people so far, announced on Monday that it will be expanding its services to a new market: the United States.
Detecting heart disease through the eyes
While the idea behind THEIA was to provide patients with access to a simple eye health check through their primary care doctor, the company soon realized that it could detect more than conditions like diabetic Retinopathy, AMD, and cataracts; it could actually detect cardiovascular disease through changes in the blood vessels in the back of the eye.
"These changes are tiny and the clinician’s eye is not trained to look for them in an image, but the artificial intelligence can see them. So, about a year ago, we realized that our AI is not only showing us disease of the eye, sometimes it's showing us something a comorbidity that is related to a disease of the eye," said Vaghefi.
"Many times a blinding condition is a surrogate marker for something else. For example, you have hypertension, and it leads to bleeding in your eye, which leads to blindness, or you have diabetes, which leads to leakages of blood into the eye that leads to blindness."
While eye doctors and ophthalmologist only tend to see these changes at the very end stages of the disease, when the problem has already gotten to the point where it's noticable, ORAiCLE can detect it the beginning, years before the disease manifests itself, meaning that the patient can get a head start on the potential problem before it's too late.
Toku Eyes’ platform is already being used as part of diabetic screening service in both the public and private sectors in New Zealand. It is also live in 20 clinics in India with the goal to be in 70 by the end of the year. So far, Toku's products have been used by around one million people across both countries.
So far, THEIA has shown to be 96% accurate in its diagnosis, as compared to 90% for general ophthalmologists, while ORAiCLE is 25% more accurate in calculating cardiovascular risk than assessment tools on the American Heart Association and Mayo Clinic websites.
In terms of ROI, Toku has been shown to reduce the cost of screening, and increase the capacity of the same clinic, by 50% in New Zealand.
Expanding to the U.S.
While THEIA currently acts as a diagnostic tool for eye diseases, ORAiCLE is classified as a risk assessment tool (though the company hopes to change that over the next few years). As such, only ORAiCLE will initially be available in the U.S., as the company is currently seeking FDA approval to bring THEIA to market as well, something that Vaghefi expects to happen by the end of this year.
In the meantime, Toku has entered into partnerships with two companies to help bring its technology to patients in America, the first being EyeCheq, a company that puts robotic kiosks in retail locations; the company will be incorporating Toku's software so that patients will be able to walk up to a kiosk and immediately capture an image of their eye.
"They wanted to have a whole team of clinicians in the background, assessing all the images that are coming through from these kiosks. Our collaboration with them is that you don't need a team of clinicians, you just need one or two auditors, and the AI will just go through all the images and alert those that need to be seen by a clinician," Vaghefi explained.
"Also, we can also identify people that are at high risk of cardiovascular events, and then work with that retailer, so the location that the camera is in, to see what other services can be provided for that person, including consultation, supplementation, and education."
The other partnership is with Unified-Imaging, an image repository platform that gathers images from camera manufacturers. Toku will work with the company to be more of a data analytics platform.
"Based on these images, you can tell so much about this person. So, not only that person might get a referral, they might also get to be connected to these other points, like cardiology or nephrology," said Vaghefi.
Through these partnerships and more, Toku eyes is planning, subject to finalizing regulatory clearances, to be present at more than 1,500 locations across the U.S. by 2025.
Of course, there are challenges that come with entering the U.S. health market, not the least of which is determining who will pays for this. Unlike New Zealand, which has a public health system, meaning the government pays for everything, the U.S. health market is much more complex.
"My day and night is consumed with who pays. The United States is interesting because there is a CPT code for use of AI for analyzing eye images. That's one path; that code has been adopted by Medicare and Medicaid. So, we are looking into that but, at the same time, we believe that the cardiovascular product is very much an insurance or value-care provider product," Vaghefi explained.
"It can tell an HMO or an insurance company, 'the overall risk of your population is this and this is the 5% of your population that's going to consume 50% of all the cost. If you focus on this population, and reduce the incidence rate in this 5% of the population, you're going to save more than 50% of your entire intervention budget.' We think there is an angle there. But, again, there’s a bit of work to be done."
Making eye care accessible to everyone
All of this will help Toku's larger mission, which is to expand access to care, and to help prevent treatable diseases from turning into something that causes blindness, or other serious health problems.
It's for that reason that Toku has purposely made it so that its software can work with any camera, so that anyone would be able to access it and use it.
"Some other AIs are very much limited to high level, good quality, best grade cameras. We don't do that. The technology is only good if it's accessible to the lowest socioeconomic group in the society, i.e. the person who may not be able to afford to go and see a specialist. They may not even afford to go to see a doctor, but they should have access to technology," Vaghefi said.
"If it's not accessible in your Walmart or CVS or something like that, then it's not meeting my standards. So, that's why we put a lot of time and effort into our AI that can work with a lower grade, probably lower technology, camera that a CVS can afford to put in in their locations, not the $50,000 camera used by your eye specialist, but the $5,000 camera that can sit in your subway station."
In fact, the company is eventually planning on allowing patients to capture images themselves on their own mobile phones, something that will likely be more widely adopted due to the rise in virtual care and telemedicine during COVID.
This should finally make it so that more people don't run into the same situation as Vaghefi's father and lose their sight to a disease that could have been prevented if it was caught early.
"What bothers me, and what keeps me going, is that my father lost his eyesight 60 years ago and, today, the same thing can happen to another person, another child that just doesn't seem to have the access. We have had 60 years of technology innovation and nothing changed in healthcare. That's the bit that bothers me," he said.
"It's all about making sure that somebody who's coming from a low income family, maybe in a remote place, not a very well educated family, they still have access to the basic level of health, being an eye check or a cardiovascular check. Nobody should die, or go blind, because they didn't have access to a simple check. That's just not acceptable anymore."
(Image source: tokueyes.com)
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