Ehsan Vaghefi, CEO and co-founder of Toku, grew up with a blind father who lost eyesight on the age of 4 resulting from congenital glaucoma. Because of this of this, his dad was involved with the Blind Foundation in his home country of Iran. Vaghefi says most of his childhood friends were either blind or had a blind parent.
Vahefi considered becoming a clinician to assist individuals who were in an analogous boat as his father, but he also had an interest in seeing how technology could possibly be used to assist more people than any single clinician could handle. Changing course, health technology became his focus, and he founded Toku to explore ocular imaging and the diagnostic role it could play.
“Early in life, I understood that if I became a clinician, I can be limited by the variety of hours in my day, and [I] made it my mission to bring health to the masses through technology and innovation,” said Vaghefi, who can also be an associate professor in Optometry and Vision Science on the University of Auckland who has to his name also five patents, 50 publications, and greater than $15 million in grants received in research that centers across the early detection of disease through ocular imaging.
“I even have worked each day of my adult life relentlessly to bring inexpensive and accessible disease screening to everyone, all over the place, so no child would grow up with a parent who’s disabled or passed away.”
Toku’s start line is that there’s a strong link between glaucoma and heart-related conditions, so examining a patient’s eye may give a clinician an idea of how that patient’s cardiovascular system is working. Its fundamental product is a non-invasive, AI-powered retina scan and technology platform it calls CLAiR, which might detect cardiovascular risks and related diseases reminiscent of stroke, type 2 diabetes.
The platform is groundbreaking in its approach: CLAiR uses AI to “read” tiny signals from the blood vessels captured within the retinal images, and Toku claims that it could calculate heart disease risk, hypertension, or high cholesterol in 20 seconds. And since the platform integrates with existing retinal imaging cameras, the diagnostics it measures can feasibly turn out to be a component of any routine eye exam.
The corporate raised an $8 million Series A funding round earlier this yr from U.S. optical retailer National Vision and Japanese firm Topcon Healthcare. However it remains to be in its early stages.
The U.S. Food and Drug Administration (FDA), earlier this month, granted “breakthrough device status” to CLAiR, which might run on existing retinal imaging cameras.
The FDA’s breakthrough device designation “significantly shortens the de novo process” to achieve the market, the CEO explained. It gives Toku access to “a chosen FDA team of experts working with the startup to de-risk the accreditation process,” he added.
“Every product that obtains its final FDA approval through the breakthrough designation program has the chance to receive an automatic current procedural terminology (CPT) reimbursement code immediately after the ultimate approval,” Vaghefi said.
But this also signifies that it’s not available on the market yet. If ultimately cleared and accredited by the FDA, the startup claims it’s going to be the primary medical device company within the U.S. to supply a reasonable, non-invasive method to detect the danger of CVD using the image of the retina situated behind the attention.
The startup, which has 20 staff, started off in Auckland, Latest Zealand, in 2019. It moved its headquarters to San Diego, California, earlier this yr.
Toku goals to start its pivotal trial in mid-2024, bringing it to the market by 2025-end. It’s currently working with strategic backers reminiscent of Topcon Healthcare and National Vision to arrange for that rollout after final approval.
Toku, notably, isn’t the primary startup that has built a tool to predict heart problems by analyzing an individual’s retina.
Five years ago, Google and Alphabet’s Verily said that they were developing an AI algorithm that might predict heart disease risks by scanning a patient’s eye. This has yet to roll out, nonetheless. Meanwhile, the brand new AI tool could also replace a series of conventional tests reminiscent of CT scans, MRIs and X-rays. MediWhale, a South Korea-based startup that has also built an AI-based non-invasive retina scan to diagnose cardiac and kidney disorders, is one other similar company.
Toku’s typical end-users will probably be asymptomatic adults with routine eye exams: the plan is to deploy it at retail optometry, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras.
Once CLAiR identifies individuals with elevated cardiovascular risk, these patients will probably be referred to their primary care providers for added tests. When asked about its privacy and data retention policy, Toku said it complies with the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483, ensuring that only authorized parties can access a patient’s health data.
“We don’t use patient information for research or AI training unless explicitly immediately,” the CEO said. “The patient can request for his or her data to be deleted at any time, and it’s going to be actioned immediately. We comply with data sovereignty in every jurisdiction, using local servers and infrastructure.”