Toku Inc. Secures FDA Breakthrough Designation for Technology that Identifies Chronic Kidney Disease Risk Through the Eye

MyKidneyAI Becomes the Company’s Second Innovation to Recently Receive this FDA Distinction

SAN DIEGO--(BUSINESS WIRE)--Toku, Inc., a commercial medical device company specializing in imaging technology and AI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its MyKidneyAI technology. MyKidneyAI uses AI to analyze retinal images collected at routine eye exams to detect elevated chronic kidney disease (CKD) risk in people with diabetes. Most people with diabetes are not routinely screened for CKD today, resulting in the disease not being detected until it has developed to an advanced stage where straightforward interventions are no longer effective.

"MyKidneyAI's groundbreaking early screening technology offers a way to detect CKD in its earliest stages, when therapies can be instituted to attenuate or prevent disease progression and may significantly reduce the roughly 360 patients starting dialysis every day in the United States," said Glenn Chertow M.D., M.P.H, Professor of Medicine (Nephrology) and (by courtesy) Professor of Epidemiology and Population Health, and Health Policy at Stanford University School of Medicine.

The retina, located in the back of the eye, is the only part of the vascular system that can be photographed easily to detect microvascular disease, a key contributor to CKD. Toku developed MyKidneyAI to help identify individuals with diabetes who have elevated CKD risk via a simple eye exam available in eye care or primary care settings. Toku is working closely with its strategic investors, Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, and National Vision, one of the largest optical retailers in the United States, to provide MyKidneyAI in the U.S. market.

CKD is a general term used to describe disorders affecting kidney structure and function. According to the National Kidney Foundation, CKD affects approximately 15% of the U.S. population, but nine out of 10 people with CKD are unaware that they have the condition. Patients with impaired kidney function experience markedly higher rates of death and cardiovascular events. CKD is generally asymptomatic until it reaches an advanced stage, requiring dialysis or kidney transplantation. Diabetes is the leading cause of kidney disease in developed and developing countries. About 40% of people with diabetes have CKD, but screening is not routinely performed.

"Given the potential impact of this technology for people with CKD, we are extremely proud to have advanced MyKidneyAI so quickly,” said Ehsan Vaghefi, Toku’s CEO. “We have now achieved two FDA Breakthrough designations in under a year, which is particularly impressive because we are one of only a handful of startup companies to do so in the FDA Breakthrough Devices program’s history. This is a testament to our team's innovative approach and commitment to making a significant impact in healthcare.”

Toku secured its first FDA Breakthrough designation for its cardiovascular risk identification product, CLAiR, just six months ago. FDA's Breakthrough designation expedites the review process, shortening the time until technology reaches patients if cleared by the FDA.

Managing patients with CKD costs Medicare over $130 billion each year, with $35 billion (over 7% of total Medicare spending) going to care for the 0.1% of the population suffering from kidney failure. Earlier identification of patients with CKD is key to enabling both clinical and economic improvement.

“The eyes offer a window into overall health, and at National Vision we know an eye exam can be a critical touch point for patients to get the care they need for chronic conditions,” said Priti Patel, O.D., National Vision’s senior vice president of healthcare strategy and development. “Toku’s groundbreaking utilization of retinal images and advancements in the AI space underscores our dedication to leveraging innovation for improved patient outcomes as well as the transformative potential of AI across medical disciplines.”

Ali Tafreshi, CEO & President of Topcon Healthcare, Inc. stated, “We remain committed to supporting Toku’s mission in bringing Healthcare from the Eye to people across the globe.”

About Toku, Inc.

Toku, Inc. is a cutting-edge technology company that specializes in developing non-invasive, AI-powered diagnostic and screening tools using retinal imaging to measure cardiovascular and other health risk factors. The company’s first commercialized product, BioAge, analyzes biometric markers visible in the retinal image to accurately measure an individual’s biological age. The test can provide a detailed report on an individual’s overall health. The Company is also developing the CLAiR platform, an AI-powered technology to assess cardiovascular risk by means of retinal photographs of the back of the eye. The CLAiR platform has received Breakthrough Device designation from the FDA in November 2023 and CE & UKCA Marks in 2024. MyKidneyAI is the latest in Toku’s suite of products. Toku is committed to making its technology widely accessible through its major partnerships across the world. The company’s technology is built on the latest research in AI, and its team of experts includes leading scientists and medical professionals.