Ehsan Vaghefi, CEO and co-founder of Toku, grew up with a blind father who lost eyesight at the age of four due to congenital glaucoma. As a result of this, his dad was involved with the Blind Foundation in his home country of Iran. Vaghefi says most of his childhood friends were either blind or had a blind parent.
Vaghefi thought of becoming a clinician to help people who were in a similar situation as his father, but he also had an interest in seeing how technology could be used to help more people than any single clinician could handle. Changing course, health technology became his focus, and he founded Toku to explore ocular imaging and the diagnostic role it can play.
“Early in life, I understood that if I became 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 in Optometry and Vision Science at the University of Auckland who has to his name five patents, 50 publications and more than $15 million in grants received in research that centers around the early detection of disease through ocular imaging.
“I have worked every day of my adult life relentlessly to bring affordable and accessible disease screening to everyone, everywhere, so no child would grow up with a parent who is disabled or passed away.”
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 that patient’s cardiovascular system is working. 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 and type 2 diabetes.
The platform is groundbreaking in its approach: CLAiR uses AI to “read” tiny signals from the blood vessels captured in the retinal images, and Toku claims that it can calculate heart disease risk, hypertension or high cholesterol in 20 seconds. And because the platform integrates with existing retinal imaging cameras, the diagnostics it measures can feasibly become a part of any routine eye exam.
The company raised an $8 million Series A funding round earlier this year from U.S. optical retailer National Vision and Japanese firm Topcon Healthcare. But it is still in its early stages.
The U.S. Food and Drug Administration (FDA), earlier this month, granted “breakthrough device status” to CLAiR, which can run on existing retinal imaging cameras.
The FDA’s breakthrough device designation “significantly shortens the de novo process” to reach the market, the CEO explained. It gives Toku access to “a designated FDA team of experts working with the startup to de-risk the accreditation process,” he added.
“Every product that obtains its final FDA approval through the breakthrough designation program has the opportunity to receive an automatic current procedural terminology (CPT) reimbursement code immediately after the final approval,” Vaghefi said.
But this also means that it’s not on the market yet. If ultimately cleared and accredited by the FDA, the startup claims it will be the first medical device company in the U.S. to offer an affordable, non-invasive way to detect the risk of CVD using the image of the retina located in the back of the eye.
The startup, which has 20 staff, started out in Auckland, New Zealand, in 2019. It moved its headquarters to San Diego, California, earlier this year.
Toku aims to begin its pivotal trial in mid-2024, bringing it to the market by the end of 2025. It is currently working with strategic backers such as Topcon Healthcare and National Vision to prepare for that rollout after final approval.
Toku, notably, isn’t the first startup that has built a tool to predict cardiovascular disease by analyzing a person’s retina.
Five years ago, Google and Alphabet’s Verily said they were developing an AI algorithm that could predict heart disease risks by scanning a patient’s eye. This has yet to roll out, however. Meanwhile, the new AI tool could also replace a series of conventional tests such as CT scans, MRIs and X-rays. MediWhale, a South Korea-based startup that has also built an AI-based non-invasive retina scan to diagnose cardiac and kidney disorders, is another similar company.
Toku’s typical end-users will be asymptomatic adults with routine eye exams: The plan is to deploy it at retail optometry, primary care offices, ophthalmology clinics and pharmacies equipped with retinal cameras.
Once CLAiR identifies individuals with elevated cardiovascular risk, these patients will be referred to their primary care providers for additional tests. 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 a patient’s health data.
“We do not use patient information for research or AI training unless explicitly immediately,” the CEO said. “The patient can request for their data to be deleted at any time, and it will be actioned immediately. We comply with data sovereignty in every jurisdiction, using local servers and infrastructure.”