Ehsan Vaghefi, CEO and co-founder of Tokugrew up with a blind father who lost his sight at the age of four due to congenital glaucoma. Because of this, his father was involved with the Blind Foundation in his home country of Iran. Vaghefi said most of his childhood friends were blind or had blind parents.
Vahefi thought about becoming a clinician to help people in the same boat as his father, but he was also interested in seeing how technology could be used to help more people than any single clinic could. Changing course, health technology became his focus, and he founded Toku to explore ocular imaging and the diagnostic role it could play.
“Early in life, I understood that if I were to become a clinician, I would be limited by the number of hours in my day, and (I) made it my mission to bring health to the masses through technology and innovation ,” said Vaghefi, who is also an associate professor of Optometry and Vision Science at the University of Auckland who also has five patents, 50 publications, and more than $15 million in grants received in research focused on early detection. of disease by ocular imaging.
“I have worked every day of my adult life non-stop to bring affordable and easy disease screening to everyone, everywhere, so that no child grows up with a disabled or deceased parent.”
Toku’s starting point is that there is a strong link between glaucoma and heart-related conditions, so examining a patient’s eye can give a clinician an idea of how the cardiovascular system is doing. patient. Its main product is a non-invasive, AI-powered retina scan and technology platform it calls CLAiR, which can detect cardiovascular risks and related diseases such as stroke, type 2 diabetes.
The platform is groundbreaking in its approach: CLAiR uses AI to “read” tiny signals from blood vessels captured in retinal images, and Toku claims it can calculate disease risk in heart, hypertension, or high cholesterol in 20 seconds. And because the platform integrates with existing retinal imaging cameras, the diagnostics it measures can become part of any routine eye exam.
Raised the company an $8 million Series A funding round earlier this year from US optical retailer National Vision and Japanese firm Topcon Healthcare. But it is still in its early stages.
The US Food and Drug Administration (FDA), earlier this month, provided “status of the breakthrough device” to CLAiR, which can run on existing retinal imaging cameras.
The FDA’s breakthrough device designation “shortens the de novo process” to reach the market, the CEO explained. This gives Toku access to “a designated group of FDA experts who work with the startup to de-risk the accreditation process,” he added.
“Each product that receives final FDA approval through the breakthrough designation program has the opportunity to receive an automatic current procedural terminology (CPT) reimbursement code immediately following final approval,” Vaghefi said.
But this also means that it is not yet on the market. If eventually cleared and accredited by the FDA, the startup claims it will be the first medical device company in the US to offer a low-cost, non-invasive way to determine CVD risk using imaging of retina located at the back of the eye.
The startup, which has 20 employees, started in Auckland, New Zealand, in 2019. It moved its headquarters to San Diego, California, earlier this year.
Toku refers to its initiation important test in the middle of 2024, which brings it to the market in 2025-end. It is currently working with strategic backers such as Topcon Healthcare and National Vision to prepare for launch after final approval.
Toku, in particular, is not the first startup to build a tool to predict cardiovascular disease by analyzing a person’s retina.
Five years ago, Google and Alphabet’s Verily SAYS that they developed an AI algorithm that can predict the risks of heart disease by scanning the patient’s eyes. It hasn’t been rolled out yet, though. Meanwhile, the new AI tool can also replace a series of conventional tests such as CT scan, MRI and X-ray. MediWhale, a South Korea-based startup that is also building an AI-based non-invasive retina scan to detect heart and kidney diseases, is another similar company.
The typical end-users of Toku are asymptomatic adults with routine eye exams: the plan is to deploy it in retail optometry, primary care offices, ophthalmology clinics, and pharmacies with retinal cameras.
Once CLAiR identifies individuals at high cardiovascular risk, these patients will be referred to their primary care providers for further testing. When asked about its privacy and data retention policy, Toku said it complies with the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483, ensuring that only authorized parties can access health data in patient.
“We will not use patient information for AI research or training unless it is immediately clear,” the CEO said. “The patient can request for their data to be deleted at any time, and it works immediately. We comply with data sovereignty in each jurisdiction, using local servers and infrastructure.