FDA-clinical trial shows AEYE Health detects diabetic retinopathy
Screening for risk of blindness is more accurate, quicker, cheaper
- Strong FDA Phase III clinical trial data shows AEYE Health's industry-leading retinal screening system is more accurate, faster and affordable than previous solutions, pending FDA approval
- System eases access to screening for millions of patients at high risk for blindness from diabetic retinopathy who are currently undiagnosed
- CPT reimbursement code, partnership with Optomed, enable primary care physicians to create new profit center
- Company believes camera-independent system can diagnose glaucoma and 13 more dangerous conditions with single scan
- Pre-revenue $5.5M Series C round led by OurCrowd with participation from BioLight, Naska Medical, Club100
"Leveraging the power of AI to promote adherence to screening protocols is nothing less than sight saving" – Prof. Shlomit Schaal, MD, PhD, MHCM, Chair, Department of Ophthalmology and Visual Sciences, UMass Medical School
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Dear Josb,
Millions of people worldwide at high risk of blindness go undiagnosed each year, preventing the early intervention that could save their sight. OurCrowd is investing in AEYE Health, whose industry-leading AI-powered platform can diagnose a range of conditions from a single retinal image using any hand-held fundus camera. The details in this email are based on information received from, and verified solely by, the company.
FDA-clinical trial
Results of a Phase III FDA-clinical trial show that AEYE Health's platform can accurately detect more-than-mild diabetic retinopathy – a leading cause of blindness affecting millions of people that is currently undiagnosed in the majority of patients.
The successful trial places the company on track to start sales in partnership with Optomed, a manufacturer of fundus cameras for retinal screening, after clearance is obtained from the FDA.
The clinical trial data of AEYE Health's artificial intelligence platform shows strong efficacy and the first of its kind solution to use only a single image from each eye, simplifying the diagnostic procedure and reducing screening time, using either a desktop or hand-held retinal camera. The system is camera independent.
AEYE Health is now seeking FDA clearance for its autonomous screening solution for diabetic retinopathy.
Business model
AEYE Health's system is portable, quicker, cheaper and more accurate, bringing early diagnosis within the reach of small clinics and primary care physicians. It requires no specialist expertise and can replace the more expensive and complex systems currently limited by bulk, complexity and cost to specialists and large healthcare facilities.
A dedicated CPT code for AI diagnosis guarantees full reimbursement for diabetic retinopathy screening. AEYE Health's camera/software partnership with Optomed enables the complete system to be provided to clients – following FDA clearance – as a bundle with a monthly subscription, allowing small clinics and medical practices to create a new profit center with minimal usage and avoid upfront capital outlay.
The company is also preparing to publish its results in diagnosing glaucoma using the same system. The company believes its technology can diagnose 14 dangerous conditions using the same method.
Millions at risk
Less than half of the 420 million people worldwide – 35 million of them in the US – who are at risk for diabetic retinopathy currently undergo the screening required for the early diagnosis and intervention that could save their sight.
Widespread adoption of the AEYE system could have an enormous impact, helping to prevent the loss of sight for millions of people who currently have limited access to the necessary screening.
"Leveraging the power of AI to promote adherence to screening protocols is nothing less than sight saving," says Shlomit Schaal, MD, PhD, MHCM, Professor and Chair of UMass Medical School's Department of Ophthalmology and Visual Sciences, which is testing the AEYE system. "Early detection and intervention are crucial in preventing severe vision loss."
The sector
IDX, a competitor that requires a specific, larger camera system, recently raised an investment round at $150M post-money valuation. The current round values AEYE at $55M pre-money.
Results: FDA-clinical trial for the autonomous detection of more-than-mild diabetic retinopathy. (Released Feb. 7, 2022).
Observed AI results for each camera system:
- Topcon NW-400 (desktop camera): 93.0% sensitivity, 91.4% specificity, >99% imageability
- Optomed Aurora (handheld camera): 91.9% sensitivity, 93.6% specificity, >99% imageability
(A single image per eye was used for both the desktop and the handheld cameras.)
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