In an era where technology and health are increasingly intertwined, Toku, a burgeoning startup, stands at the forefront of this revolution. Founded by Ehsan Vaghefi, Toku harnesses the power of AI to transform eye exams into a gateway for detecting heart conditions. Vaghefi’s journey to this innovation is deeply personal, rooted in his childhood experiences with his blind father and his connections to the Blind Foundation in Iran. This backdrop fueled his passion for using technology not just to treat, but to transcend the limitations of traditional healthcare.

Vaghefi, an associate professor in Optometry and Vision Science at the University of Auckland, combines his academic prowess with entrepreneurial zeal. His journey is underpinned by a noble goal: to democratize healthcare and ensure no child grows up with a parent disabled or lost to preventable diseases. His credentials are impressive – five patents, 50 publications, and over $15 million in research grants, all dedicated to the early detection of disease through ocular imaging.

At the heart of Toku’s innovation is CLAiR, an AI-powered retina scan technology. CLAiR is a non-invasive tool that “reads” minute signals in blood vessels through retinal images, offering insights into cardiovascular health. This groundbreaking approach allows for the detection of risks associated with heart disease, hypertension, and high cholesterol in mere seconds. The integration of CLAiR with existing retinal imaging cameras is a game-changer, potentially making cardiovascular screening a routine part of eye exams.

CLAiR’s potential has been recognized by key players in the health and optical industry, evidenced by Toku’s successful $8 million Series A funding round. The investment from National Vision, a U.S. optical retailer, and Topcon Healthcare, a Japanese firm, signifies confidence in Toku’s vision.

The recent “breakthrough device status” granted by the U.S. Food and Drug Administration (FDA) is a testament to CLAiR’s potential. This designation accelerates the market access process, bringing Toku’s vision closer to reality. The FDA’s support includes a dedicated team to guide Toku through the accreditation process and the promise of an immediate reimbursement code upon final approval.

While still in the pipeline, with a planned market launch by 2025, Toku’s ambition is clear: to be the first in the U.S. to offer an affordable, non-invasive method for detecting cardiovascular disease risks using retinal imaging. Toku’s journey from its humble beginnings in Auckland, New Zealand, to its current base in San Diego, California, is a story of innovation crossing borders.

However, Toku isn’t alone in this endeavor. Other tech giants, like Google and Verily, have explored similar AI algorithms for heart disease prediction using retinal scans. MediWhale, a South Korean startup, is also in the race, developing non-invasive retina scans for diagnosing cardiac and kidney disorders. Yet, Toku’s unique approach and comprehensive strategy position it as a potential leader in this space.

Toku’s end-users, asymptomatic adults undergoing routine eye exams, stand to benefit significantly. The plan is to deploy CLAiR across retail optometry, primary care offices, ophthalmology clinics, and pharmacies with retinal cameras. The identification of individuals with elevated cardiovascular risk will enable timely referrals for further testing.

In addressing privacy concerns, Toku is committed to compliance with the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483. Their robust data retention policy ensures that patient information is used responsibly and only with explicit consent, with provisions for data deletion upon request.

Toku’s story is more than a tale of technological innovation; it’s a beacon of hope in the quest for accessible and preventative healthcare. As we look to the future, Toku’s AI-driven approach to heart health signifies a leap forward, not just in medical technology, but in our collective journey towards a healthier world.