The FDA has granted Breakthrough Device Designation to Toku Inc.’s patented CLAiR technology platform, designed to provide a non-invasive cardiovascular disease (CVD) evaluation using fundus retinal imaging.
Refresh me on what a breakthrough therapy designation is.
A breakthrough therapy designation is intended to expedite the development and review process for new medical devices or drugs designed to treat or diagnose a serious or life-threatening disease.
In order to qualify, a medical device needs to have either breakthrough technology, no approved/cleared alternatives, significant advantages compared to any existing approved/cleared alternative devices, or have its availability be in the best interest for its target patients.
And this company?
Based in Auckland, New Zealand, Toku is a commercial medical device company with a specific focus in developing non-invasive, artificial intelligence (AI)-controlled diagnostic and screening tools via retinal imaging.
The goal: measuring health risk factors (such as cardiovascular disease).
Any commercialized products yet?
Yes—the BioAge Test, currently available in New Zealand and Australia.
Through retinal imaging techniques, the test analyzes biometric markers within the human body with the potential to accurately measure a person's biological age as well as produce a detailed report on their overall health and health risks.
And the target audience for this: eyecare professionals (ECPs).
Okay, now talk about this CLAiR platform.
Intended for in-office use during comprehensive eye examinations, the artificial intelligence (AI)-powered technology is designed to integrate with existing retinal imaging cameras to provide CVD risk assessments in real-time.
To note, the platform was originally released in the U.S. in 2022 as a wellness device.
Click here for a visual.
How, exactly?
By interpreting signals sent through retinal images of blood vessels to identify elevated CVD risk that may be caused by factors like genetics, hypertension, or high cholesterol.
And before you ask “Why the retina,” we’ll tell you: because the eye is the only portion of the body where these blood vessels can be non-invasively photographed.
Gotcha. So then what’s next?
The results of the assessment can then be shared with a patient’s primary care physician (PCP) for them to begin a comprehensive CVD evaluation and determine next steps for potential treatment or management.
And how does this compare to standard CVD assessments?
Per the company, these assessments are intended to be comparable to traditional risk assessment tools that typically include multiple measurements / blood tests.
However, where standard CVD tests often take weeks for results, the CLAiR platform is intended to deliver more accurate and rapid results.
And the significance?
According to Toku CEO and Co-Founder Ehsan Vaghefi, PhD, this FDA designation is a validation of the CLAiR platform’s potential for patients who may unknowingly be at risk for CVD.
Further, as part of the FDA’s Breakthrough Devices program, an accelerated review process and prioritized evaluation for potentially faster market access is now in reach for the company.
So what’s next?
The premarket review phase has officially begun, where Toku will work with the FDA to identify areas of agreement. The company could also potentially receive prioritized review of the system’s U.S. regulatory submission.
And what’s the end goal here?
Per Toku, to establish the largest CVD risk assessment network across the United States (and eventually the globe).
But first the first will be to await FDA clearance for the CLAiR platform to become the first medical device in the U.S. market to provide “affordable, point-of-care and non-invasive evaluation” for CVD risk.