Toku Wins CE, UKCA Marks for AI-Enabled Cardiovascular Risk Assessments

Toku Inc. has obtained CE and UKCA Marks for its patented CLAiR technology. 
 
CLAiR provides accurate, affordable, non-invasive evaluation of cardiovascular disease (CVD) risk through retinal images captured during a routine eye exam. Located in the back of the eye, the retina is the only part of the vascular system that can be photographed easily and non-invasively. The CLAiR technology integrates readily with existing retinal cameras to provide real-time CVD risk assessments with accuracy comparable to gold standard cardiovascular risk assessments (which typically require blood tests and can take weeks). The artificial intelligence-powered CLAiR technology identifies elevated cardiovascular risk by analyzing minute changes in the retina and its vasculature. CLAiR results can be shared with a patient’s primary care physician, who can initiate a comprehensive cardiovascular evaluation to guide prevention.

“I believe that a retinal image can be considered the ‘fifth vital’ along with temperature, heart rate, respiration rate, and blood pressure,” Toku CEO Associate Professor Ehsan Vaghefi said. “The CE and UKCA marks allow us to bring CLAiR to patients across multiple geographies. In my vision of the future, a retinal image analysis is an integral part of a comprehensive screening for major diseases such as cardiovascular or kidney disease.”
 
Retinal imaging is routinely performed in many eye care settings and is increasingly being used in pharmacy and primary care clinics across the United Kingdom and European Union. CLAiR will enable healthcare providers in various settings to identify elevated cardiovascular risk in adult patients with no known history of cardiovascular disease.
 
“The eye is the only organ of the body where we can non-invasively view and image blood vessels,” stated professor John Marshall, holder of the original patents for refractive surgery and Emeritus Professor of Ophthalmology at both University College London & Kings College, London. “The advent of artificial intelligence has enabled analysis of retinal images to predict the occurrence and time course of numerous diseases of the vascular system, including heart attacks and strokes. Such early risk identification allows timely modification of lifestyle and even earlier treatment to prevent or delay onset. Toku’s CLAiR algorithm is a major breakthrough in the field of cardiovascular diseases and should result in lifesaving interventions and improved quality of life for innumerable individuals throughout the world.”
 
Based in San Diego, Toku specializes in converting routine eye exams to comprehensive health screening by developing AI-powered tools. The company’s first commercialized product, BioAge, uses AI to analyze biometric markers in the retina to accurately identify an individual’s biological age. In the United States the CLAiR platform has received U.S. Food and Drug Administration Breakthrough Device designation. Toku’s Series A financing was co-led by National Vision Inc., one of the largest optical retailers in the United States, and Topcon Healthcare, a leading provider of medical devices and intelligent software solutions for the global eye care community.