Published on November 17, 2023, 10:53 am

Ehsan Vaghefi, the CEO and co-founder of Toku, has a personal connection to the mission and vision of his company. With a blind father who lost his eyesight at a young age, Vaghefi grew up surrounded by individuals who were visually impaired. This experience led him to consider a career in healthcare as a clinician to assist people facing similar challenges.

However, Vaghefi’s interest in leveraging technology to help a larger number of people pushed him to change course and focus on health technology instead. In pursuit of this goal, he established Toku with the intention of exploring ocular imaging and its potential diagnostic applications.

Vaghefi’s mission is to make affordable and accessible disease screening available to everyone. Through Toku’s flagship product called CLAiR, an AI-powered retina scan and technology platform, the company aims to detect cardiovascular risks and related conditions such as stroke and type 2 diabetes.

What makes CLAiR unique is its ability to examine tiny signals from blood vessels captured in retinal images using AI. By analyzing these signals, the platform can accurately calculate heart disease risk factors, hypertension, and high cholesterol in just 20 seconds. Additionally, because CLAiR integrates seamlessly with existing retinal imaging cameras, its diagnostics can easily become part of routine eye exams.

Toku has already made significant strides towards achieving its goals. Earlier this year, the company secured an $8 million Series A funding round from U.S. optical retailer National Vision and Japanese firm Topcon Healthcare. Moreover, CLAiR recently received “breakthrough device status” from the U.S. Food and Drug Administration (FDA), enabling Toku to expedite its journey through the accreditation process for market entry.

Receiving this designation allows Toku access to an FDA team dedicated to helping the startup navigate regulatory requirements effectively. It also presents an opportunity for the company to obtain reimbursement codes immediately following FDA approval—a significant advantage in terms of market positioning.

While Toku is not yet available on the market, it aims to change that. The company plans to commence its pivotal trial in mid-2024, with the goal of making CLAiR commercially available by the end of 2025. To prepare for this, Toku is working closely with strategic backers like Topcon Healthcare and National Vision.

It’s worth noting that Toku is not the only startup exploring the use of retinal imaging for cardiovascular disease detection. Google and Alphabet’s Verily, for instance, announced five years ago their development of an AI algorithm capable of predicting heart disease risks through retinal scans. However, these efforts have yet to materialize on a widespread scale.

Toku’s target users will primarily be asymptomatic adults undergoing routine eye exams. The company plans to deploy its technology at retail optometry locations, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras. Once CLAiR identifies individuals with elevated cardiovascular risks, they will be referred to their primary care providers for further testing.

To address privacy concerns, Toku ensures compliance with legal regulations such as the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483. This guarantees that only authorized parties can access patient health data. Furthermore, Toku does not utilize patient information for research or training purposes unless explicitly approved by the patient themselves. Patients also have the right to request immediate deletion of their data upon request.

With its groundbreaking approach and commitment to accessibility and affordability, Toku is poised to revolutionize disease screening and contribute significantly to preventive healthcare efforts. By leveraging generative AI technology in ocular imaging, they strive toward a world where no child grows up with a parent who is disabled or has passed away due to undetected illnesses.

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