We are pleased to announce the formal submission of our application for a CE mark for our PRIMA retinal implant to our notified body for review. With this key step, we are moving closer to bringing to market the first brain-computer interface technology to restore functional form vision to patients blinded with late-stage age-related macular degeneration (AMD).
The CE mark (short for Conformité Européenne, or “European Conformity”) indicates that a device complies with European Union regulations, including health and safety standards. Our application—tens of thousands of pages of technical specifications, clinical data, and quality systems documentation, about 60GB in digital form—is a critical step in making PRIMA available throughout the European market and will represent both an important treatment milestone and a key event for our company.
The PRIMA implant has completed a major European clinical trial which represents, to our knowledge, the first time that some patients with central vision loss due to macular degeneration were able to intuitively read again. During the trial, patients were able to recognize playing cards and fill in crossword puzzles, among other tasks.
PRIMA is based on technology originally developed by Dr. Daniel Palanker and his team at Stanford University.
What Happens Next
Our submission triggers a multi-phase assessment that will scrutinize every aspect of our technology. The process isn’t simple, nor should it be—the bar has been deliberately set high to ensure only genuinely safe and effective devices reach patients.
We are confident about what this new technology will mean to patients. We also understand and appreciate the regulatory environment. A technical documentation review period, a quality system audit, and a decision period means we expect to receive a decision on our CE mark application next year.
What the CE Mark Will Mean
Once secured, the CE mark will allow us to market our device across 30+ European countries without additional country-level approvals. For PRIMA, this represents a singular opportunity: access to a huge medical device market through a single regulatory pathway.
More importantly, it will validate years of R&D, clinical research, and our fundamental thesis about addressing this critical unmet need. In our conversations with clinicians and patient advocacy groups, it has become clear that people with degenerative retinal diseases are in need of innovative technology.
Millions of people have age-related macular degeneration (AMD); this generation of our PRIMA implant technology is designed to treat a subset with advanced AMD called geographic atrophy where vision loss is severe in both eyes. We are developing the next version of the implant and glasses which will optimize visual performance further with digital image processing, streamlined ergonomics, and increased visual resolution to bring this technology to more patients.
Preparing For Success
Over the coming months, while regulatory approval is pending, we’ll be:
- Developing our commercial-stage clinical infrastructure plans
- Continuing clinical data collection to strengthen our post-market surveillance framework
- Completing manufacturing scale-up to ensure supply chain readiness
In the United States, PRIMA received FDA Breakthrough Device status in 2023, and this spring we requested Humanitarian Use Device Designation to bring this important technology to U.S. patients. Discussions with the FDA are ongoing about the right translational pathway for PRIMA to eventually reach American patients.
The world has had cochlear implants for over 50 years now. It’s our sincere hope that soon we will enter an era where there are commercially available retinal prostheses too for patients who suffer from irreversible blindness due to loss of the rods and cones in the eye. We’re not quite there yet, but we believe the data package for PRIMA is complete and compelling, and we stand ready to work collaboratively with our notified body, national competent authorities, and others as PRIMA continues to progress towards the market.
CAUTION: Investigational device. Limited by federal law to investigational use.
