Published on November 17, 2023, 11:23 am

Ehsan Vaghefi, CEO and co-founder of Toku, has a personal connection to the mission of bringing accessible healthcare to everyone. Growing up with a blind father who lost his eyesight at a young age due to congenital glaucoma, Vaghefi witnessed firsthand the challenges faced by individuals with visual impairments. Inspired by his father’s experience and his own interest in technology, he set out to develop innovative solutions that could help not just a few, but the masses.

Vaghefi recognized that as a clinician, he would be limited by the number of hours in a day. Instead, he decided to focus on health technology and founded Toku. The company’s main product is called CLAiR, an AI-powered retina scan and technology platform that offers non-invasive diagnostics for cardiovascular risks and related diseases like stroke and type 2 diabetes.

CLAiR uses artificial intelligence to analyze retinal images and extract valuable information from the blood vessels. In just 20 seconds, it can calculate heart disease risk, hypertension, or high cholesterol. The platform integrates seamlessly with existing retinal imaging cameras, making it feasible to incorporate these diagnostics into routine eye exams.

Toku has attracted significant attention and funding in its early stages. The company secured an $8 million Series A funding round from U.S. optical retailer National Vision and Japanese firm Topcon Healthcare. Additionally, CLAiR received “breakthrough device status” from the U.S. Food and Drug Administration (FDA), significantly expediting the accreditation process.

While Toku’s CLAiR has not yet hit the market, if cleared and accredited by the FDA, it will be the first medical device company in the U.S. to offer an affordable and non-invasive way to detect cardiovascular risks using retinal images.

With headquarters now based in San Diego after starting out in Auckland, New Zealand in 2019, Toku is preparing for its pivotal trial scheduled for mid-2024. Strategic partnerships with Topcon Healthcare and National Vision are expected to facilitate a smooth rollout after final approval.

It’s worth noting that Toku is not the only startup exploring the use of retinal imaging to predict cardiovascular disease. Google and Alphabet’s Verily announced five years ago that they were developing an AI algorithm for this purpose, but it has yet to be fully realized. Another company, South Korea-based MediWhale, has also built an AI-powered non-invasive retina scan for diagnosing cardiac and kidney disorders.

Toku’s target audience consists of asymptomatic adults who undergo routine eye exams. The plan is to deploy CLAiR in retail optometry, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras. When individuals with elevated cardiovascular risks are identified, they will be referred to their primary care providers for further tests.

Addressing concerns about privacy and data retention, Toku ensures compliance with the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483 regulations. Only authorized parties can access patient health data, which is not used for research or AI training unless explicitly permitted by the patient. Individuals can have their data deleted upon request, and Toku complies with data sovereignty in every jurisdiction by using local servers and infrastructure.

Through Toku’s innovative technology and unwavering commitment to making healthcare accessible to all, Ehsan Vaghefi hopes to prevent children from growing up with disabled or deceased parents due to undetected diseases. With the potential impact of CLAiR and similar technologies on preventive healthcare, there is newfound hope for improving early detection methods and saving lives.

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