LucyDx is developing a wearable electroretinography (ERG)-based platform intended to assess retinal function in patients with diabetes.
The company has completed development of two functional engineering prototypes, including:
• A proof-of-form headset
• A refined slim-form iteration with enhanced sensing architecture
These prototypes demonstrate signal acquisition capability. Further validation and benchmarking against predicate ERG systems are required as part of the regulatory pathway.
LucyDx is preparing for submission through the FDA 510(k) pathway and has identified predicate devices believed to be substantially equivalent.
Key next steps include:
• Formal predicate benchmarking
• Regulatory documentation finalization
• Clinical validation partnership engagement
• Completion of submission package
The device is not currently FDA-cleared and is not commercially available.
LucyDx holds a PCT patent application covering the wearable hardware platform and operates under an exclusive license agreement with a U.S. technology transfer office.
Royalty obligations are structured as a percentage of future revenue and are not triggered until commercialization.
The company anticipates that additional capital will be required to:
• Complete regulatory submission
• Conduct validation studies
• Finalize production-ready units
• Build quality systems infrastructure
Any future capital raise will be conducted in compliance with applicable securities regulations.
No public offering is currently active.
LucyDx aims to expand functional retinal diagnostics into primary care settings through a wearable form factor that may increase access and screening efficiency.
The company is focused on regulatory compliance, technical validation, and milestone-driven execution.