secures FDA Breakthrough Designation for technology that identifies chronic kidney disease risk through the eye
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 distinction from the FDA
Toku, Inc., a commercial medical device company specializing in imaging and AI technology, 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 from routine eye exams to detect increased risk of chronic kidney disease (CKD) in people with diabetes. Most people with diabetes are not routinely screened for CKD today, causing the disease to go undetected until it reaches an advanced stage where simple interventions are no longer effective.
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“MyKidneyAI’s innovative early screening technology offers a way to detect CKD in its early stages, when therapies can be instituted to mitigate or prevent disease progression and can significantly reduce the approximately 360 patients starting dialysis every day in the United States,” said physician Glenn Chertow. , MPH, 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 at the back of the eye, is the only part of the vascular system that can be easily imaged to detect microvascular disease, a major contributor to CKD. Toku developed MyKidneyAI to help identify individuals with diabetes who are at high risk for CKD through a simple eye exam available at ophthalmology or primary care settings. Toku is working closely with its strategic investors, Topcon Healthcare, a leading provider of medical devices and software solutions to the global ophthalmology community, and National Vision, one of the largest optical retailers in the United States, to provide MyKidneyAI in the US market. .
CKD is a general term used to describe disorders that affect 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 do not know they have the disease. Patients with impaired kidney function have significantly 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, CEO of Toku. “We have now achieved two FDA Breakthrough Designations in less than a year, which is particularly impressive because we are one of the few startups to do so in the history of the FDA Breakthrough Devices program. This is a testament to our team’s innovative approach and commitment to making a meaningful impact in healthcare.”
Toku secured its first FDA Breakthrough designation for its cardiovascular risk identification product, CLAiR, just six months ago. The FDA’s Breakthrough designation streamlines the review process, shortening the time until the technology reaches patients if cleared by the FDA.
Managing patients with CKD costs Medicare more than $130 billion per year, with $35 billion (more than 7% of total Medicare spending) going toward treating the 0.1% of the population that suffers. of renal failure. Early identification of patients with CKD is essential to enable clinical and economic improvement.
“The eyes offer a window into overall health, and at National Vision, we know that an eye exam can be a critical point of contact for patients to get the care they need for chronic conditions,” said Priti Patel, OD, vice- senior president of healthcare at National Vision. health strategy and development. “Toku’s innovative use of retinal imaging and advances in the AI space underscore our dedication to leveraging innovation to improve patient outcomes, as well as the transformative potential of AI across medical disciplines.”
Ali Tafreshi, CEO and President of Topcon Healthcare, Inc. stated, “We remain committed to supporting Toku’s mission of bringing eye care to people around the world.”
About Toku, Inc.
is a cutting-edge technology company specializing in developing AI-based non-invasive 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 retinal imaging 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 through photographs of the retina at the back of the eye. The CLAiR platform received FDA Breakthrough Device Designation in November 2023 and CE and 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 key partnerships around the world. The company’s technology is based on the latest research in AI, and its team of experts includes leading scientists and medical professionals.
Media:
Sam Brown Health Communications
Audra Friis
audrafriis@sambrown.com
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