By scanning your eye, Toku’s AI platform predicts heart conditions
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By scanning your eye, Toku’s AI platform predicts heart conditions

Ehsan Vaghefi, the CEO and co-founder of Toku, experienced a unique childhood. His father lost his eyesight at the age of four due to a condition called congenital glaucoma. Growing up in Iran, Ehsan’s dad actively participated in the Blind Foundation.

This organization played a significant role in supporting individuals with visual impairments. Ehsan shared that many of his childhood friends either had visual impairments themselves or had a parent facing blindness.

Ehsan Vaghefi initially considered becoming a clinician to assist individuals facing challenges similar to his father’s visual impairment. However, he was drawn to the idea of leveraging technology to reach a broader audience than one clinician could handle. This shift led him to focus on health technology, and he founded Toku to explore the potential of ocular imaging in diagnostics.

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Vaghefi, who is also an associate professor in Optometry and Vision Science at the University of Auckland, emphasized his mission to make health services accessible to the masses through technology and innovation. His extensive background includes five patents, 50 publications, and over $15 million in research grants, all centered around the early detection of diseases using ocular imaging.

toku AI

Expressing his commitment, Vaghefi stated, “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.”

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Toku’s primary focus is on the strong connection between glaucoma and heart-related conditions. The company’s flagship product, CLAiR, is an AI-powered retina scan and technology platform. It offers a non-invasive method to detect cardiovascular risks and related diseases, such as stroke and type 2 diabetes. CLAiR utilizes AI to analyze subtle signals from blood vessels in retinal images, providing quick assessments of heart disease risk, hypertension, or high cholesterol in just 20 seconds.

What sets CLAiR apart is its integration with existing retinal imaging cameras, making it feasible for these diagnostics to be part of routine eye exams. Despite being in the early stages, Toku secured an $8 million Series A funding round from U.S. optical retailer National Vision and Japanese firm Topcon Healthcare earlier this year.

Earlier this month, the U.S. Food and Drug Administration (FDA) granted “breakthrough device status” to Toku’s CLAiR, a technology that operates on existing retinal imaging cameras. This designation by the FDA expedites the approval process, providing Toku with a designated team of experts to navigate the accreditation process more efficiently.

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Ehsan Vaghefi, Toku’s CEO, highlighted that products granted final FDA approval through the breakthrough designation program may receive an automatic reimbursement code, streamlining the market entry process. However, it’s important to note that CLAiR is not yet available on the market. If successfully cleared and accredited by the FDA, Toku aims to become the first U.S. medical device company to offer an affordable, non-invasive method to detect cardiovascular disease (CVD) by analyzing retinal images.

Toku, initially founded in Auckland, New Zealand, in 2019, relocated its headquarters to San Diego, California. The company, currently with 20 staff, plans to initiate its pivotal trial in mid-2024, to bring CLAiR to the market by the end of 2025. Toku is actively collaborating with strategic backers like Topcon Healthcare and National Vision to prepare for the rollout post-final approval.

While Toku is not the first to explore the use of retinal scans to predict cardiovascular disease, its CLAiR platform distinguishes itself by potentially replacing traditional tests like CT scans, MRIs, and X-rays. Toku’s target users are asymptomatic adults undergoing routine eye exams, with plans to deploy CLAiR in retail optometry, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras.

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Upon identifying individuals at elevated cardiovascular risk, CLAiR will refer them to primary care providers for further testing. Toku ensures privacy compliance, adhering to the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483. Patient data is not used for research or AI training without explicit consent, and patients can request data deletion at any time. Toku also emphasizes adherence to data sovereignty in every jurisdiction, utilizing local servers and infrastructure.

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