Ehsan Vaghefi, the CEO and co-founder of Toku, was raised in the company of a blind father who lost his eyesight at the age of four due to congenital glaucoma. Growing up in Iran, his father’s involvement with the Blind Foundation connected him with a community where many of his childhood friends were either blind or had a blind parent.
Initially considering a career as a clinician to assist individuals facing challenges similar to his father’s, Vaghefi shifted his focus to health technology. He founded Toku with a commitment to leveraging technology to provide widespread health solutions beyond the limitations of individual clinicians. Specializing in ocular imaging and diagnostics, Toku’s primary goal is to make health screening more accessible.
Vaghefi, also an associate professor in Optometry and Vision Science at the University of Auckland, has dedicated his adult life to developing innovative solutions. Toku’s flagship product, CLAiR, is an AI-powered, non-invasive retina scan and technology platform that can swiftly detect cardiovascular risks and related conditions such as stroke and type 2 diabetes.
CLAiR utilizes AI to interpret signals from blood vessels in retinal images, claiming the ability to calculate heart disease risk, hypertension, or high cholesterol within 20 seconds. As it integrates with existing retinal imaging cameras, Toku envisions its diagnostic capabilities becoming a routine part of standard 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. Recently, the U.S. Food and Drug Administration (FDA) granted “breakthrough device status” to CLAiR, streamlining the accreditation process and potentially making Toku the first U.S. medical device company to offer an affordable, non-invasive method for detecting cardiovascular disease using retinal imaging.
While Toku plans to begin pivotal trials in mid-2024 with an aim to launch by the end of 2025, it acknowledges the challenge posed by competitors. Notably, Google and Alphabet’s Verily have also explored AI algorithms for predicting heart disease by scanning the eye. Toku’s strategic backers, such as Topcon Healthcare and National Vision, are actively involved in preparing for the market rollout.
Toku’s target users are asymptomatic adults undergoing routine eye exams. The plan is to deploy CLAiR in retail optometry, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras. Individuals identified with elevated cardiovascular risk will be referred to primary care providers for further testing.
Addressing privacy concerns, Toku emphasizes compliance with the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483. They assure that patient data is handled responsibly, with strict controls on access, and emphasize adherence to data sovereignty regulations by utilizing local servers and infrastructure in every jurisdiction.
