Toku CEO and co-founder Ehsan Vaghefi’s father was blind from congenital glaucoma at age four. Due to this, his father was active with the Iranian Blind Foundation. Vaghefi says most of his childhood pals were blind or had blind parents.
Vaghefi considered becoming a physician to aid people like his father, but he also wanted to discover how technology could benefit more people than one clinician could. He formed Toku to study ocular imaging and its diagnostic potential after switching to health technology.
A University of Auckland associate professor in Optometry and Vision Science, Vaghefi has five patents, 50 publications, and more than $15 million in grants for research on early disease detection.
“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 disabled or deceased parent.”
Toku begins by stating that glaucoma is strongly linked to heart-related disorders; hence, evaluating a patient’s eye can reveal their cardiovascular system. Its core product, CLAiR, is a non-invasive, AI-powered retina scan and technology platform that detects cardiovascular risks and diseases like stroke and type 2 diabetes.
CLAiR uses AI to “read” microscopic signals from retinal blood vessels to calculate heart disease risk, hypertension, and high cholesterol in 20 seconds, according to Toku. The technology integrates with retinal imaging cameras, making its diagnostics part of any standard eye exam.
The startup obtained $8 million in Series A funding earlier this year from National Vision and Topcon Healthcare. However, it is early.
CLAiR, which works with retinal imaging cameras, received “breakthrough device status” from the FDA earlier this month.
The CEO said the FDA’s breakthrough device designation “significantly shortens the de novo process” to market. Toku has access to “a designated FDA team of experts working with the startup to de-risk the accreditation process,” he said.
“Every product that receives final FDA approval through the breakthrough designation program can receive an automatic CPT reimbursement code immediately,” Vaghefi said.
The downside is that it’s not yet available. The startup claims it will be the first U.S. medical device company to deliver a cheap, non-invasive CVD risk assessment using retinal images, if FDA-approved.
The 20-person startup began in Auckland, New Zealand, in 2019. Early this year, it shifted its headquarters to San Diego.
Toku plans to start its pivotal trial in mid-2024 and launch in 2025. It is preparing for that deployment with strategic backers, including Topcon Healthcare and National Vision, after permission.
Toku isn’t the only firm to use retinal analysis to detect cardiovascular illness.
Google and Alphabet’s Verily announced an AI program to forecast heart disease risk by scanning a patient’s eye five years ago. However, it has yet to launch. The AI technology might also replace CT scans, MRIs, and X-rays. Another South Korean business, MediWhale, uses AI to diagnose cardiac and kidney diseases using a non-invasive retina scan.
Asymptomatic adults with regular eye checkups will employ Toku: There are plans to use it in retail optometry, primary care, ophthalmology clinics, and pharmacies with retinal cameras.
CLAiR will recommend high-risk cardiovascular patients to their primary care providers for further testing. For its privacy and data retention policy, Toku said it follows HIPAA and ISO 13483 to restrict access to patient health data.
“We do not use patient information for research or AI training unless explicitly stated,” the CEO added. “The patient can request data deletion at any time, and it will be done immediately. We use local servers and infrastructure in every jurisdiction to comply with data sovereignty.”