Ehsan Vaghefi, CEO and co-founder of Minegrew up with a blind father who lost his sight at the age of four due to congenital glaucoma. As a result of this, his father became involved in the Foundation for the Blind in his home country of Iran. Vaghefi says most of her childhood friends were blind or had blind parents.
Vahefi thought about becoming a doctor to help people who were in a similar situation as his father, but he was also interested in seeing how technology could be used to help more people than any doctor could handle. Changing gears, health technology became her focus and she founded Toku to explore ocular imaging and the diagnostic role it can play.
“At an early age I understood that if I became a doctor, I would be limited by the number of hours in my day and I set out to bring health to the masses through technology and innovation,” Vaghefi said. who is also an associate professor in Optometry and Vision Sciences at the University of Auckland and also has five patents, 50 publications and more than $15 million in grants received in research that focuses on the early detection of diseases through ocular images.
“I have worked tirelessly every day of my adult life to provide affordable and accessible disease testing to everyone, everywhere, so that no child grows up with a disabled or deceased parent.”
Toku’s starting point is that there is a strong link between glaucoma and heart-related conditions, so examining a patient’s eye can give a doctor an idea of how that patient’s cardiovascular system is functioning. His flagship product is an ai-powered non-invasive retinal scanning and technology platform he calls CLAiR, which can detect cardiovascular risks and related diseases, such as stroke and type 2 diabetes.
The platform is innovative in its approach: CLAiR uses ai to “read” small signals from blood vessels captured in retinal images, and Toku claims it can calculate the risk of heart disease, hypertension or high cholesterol in 20 seconds. And because the platform integrates with existing retinal imaging cameras, the diagnostics it measures can become part of any routine eye exam.
The company proposed an $8 million Series A financing round earlier this year from US optical retailer National Vision and Japanese firm Topcon Healthcare. But it is still in its early stages.
The US Food and Drug Administration (FDA), earlier this month, granted “innovative device status”to CLAiR, which can work with existing retinal imaging cameras.
The FDA’s breakthrough device designation “significantly shortens the de novo process” to get to market, the CEO explained. It gives Toku access to “an FDA-appointed team of experts who work with the startup to de-risk the accreditation process,” he added.
“Each product that obtains final FDA approval through the innovative designation program has the opportunity to receive an automatic Current Procedural Terminology (CPT) reimbursement code immediately upon final approval,” Vaghefi said.
But this also means that it is not on the market yet. If it eventually receives the go-ahead and accreditation from the FDA, the startup claims it will be the first medical device company in the US to offer an affordable, non-invasive way to detect CVD risk using retinal imaging. located at the back of the eye.
The startup, which has 20 employees, started in Auckland, New Zealand, in 2019. It moved its headquarters to San Diego, California, earlier this year.
Toku intends to begin his fundamental essay in mid-2024, and will bring it to market in late 2025. It is currently working with strategic sponsors such as Topcon Healthcare and National Vision to prepare for that launch after final approval.
Toku, in particular, is not the first startup to have created a tool to predict cardiovascular diseases by analyzing a person’s retina.
Five years ago, Google and Alphabet’s Verily saying that they were developing an ai algorithm that could predict heart disease risks by scanning a patient’s eye. However, this has not yet been implemented. Meanwhile, the new ai tool could also replace a number of conventional tests such as CT scans, MRIs and X-rays. MediWhale, a South Korea-based startup that has also created an intelligence-based non-invasive retinal scanner artificial to diagnose heart and kidney disorders, is another similar company.
Typical end users of Toku will be asymptomatic adults with routine eye exams: the plan is to roll it out in retail optometry, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras.
Once CLAiR identifies individuals at elevated cardiovascular risk, these patients will be referred to their primary care providers for additional testing. 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 the data. of a patient’s health.
“We do not use patient information for ai research or training unless explicitly stated immediately,” the CEO said. “The patient can request the deletion of his or her data at any time and action will be taken immediately. We comply with data sovereignty in all jurisdictions, using local infrastructure and servers.”
