US firm launches vision-restoring implant with EU approval
Prima is a thin photovoltaic sub-retinal implant that can restore vision for those with geographic atrophy.
US neural engineering company Science Corporation has received EU approval for its vision repairing medtech implant.
‘Prima’ is claimed by the company as the world’s “first and only treatment” shown to restore functional central vision in patients with geographic atrophy caused by age-related macular degeneration (AMD) – a leading cause of irreversible blindness that affects more than 5m people globally.
With regulatory approval at hand, the small, thin, photovoltaic sub-retinal implant can be commercially sold across 30 European countries.
The implant is paired with specialised glasses that project near-infrared light to the implant, which converts it into electrical stimulation signals. A ‘zoom-in’ feature enables users to magnify letters.
Science Corporation has also received the US Food and Drug Administration’s ‘Breakthrough Device’ and ‘Humanitarian Use Device’ designations, and is working to bring the device to consumers in the country.
A paper published in the New England Journal of Medicine last year showed that Prima was able to restore central vision for a majority of its participants.
Out of the 38 sample patients across 17 clinical sites in five countries, the study found 84pc reported the ability to read letters, numbers and words again, restoring functional central vision. 80pc of tested patients reportedly achieved significant visual acuity improvements.
“We are proud to be the first BCI company with a CE [Conformité Européenne] marked device for the restoration of detailed form vision,” said Science co-founder and CEO Max Hodak.
“For decades, losing central vision to this disease meant losing the ability to read, recognise faces, and ultimately losing independence. There was no viable treatment. Now there is.
“We intend to make access to Prima real and reimbursable, as quickly as possible.”
The company has announced country-specific reimbursement applications and clinical site activations across Europe. The first commercial implant is expected in Germany soon.
“The CE marking is an exciting moment, making Prima commercially available to patients,” said Prof Frank Holz, MD, the lead author of the paper and chair of the Department of Ophthalmology at the University Hospital of Bonn in Germany.
“It has been demonstrated in clinical trials that with Prima, we can restore functional central vision in patients blinded by geographic atrophy. These patients, who had lost their central vision completely, have had it restored and can read letters, numbers and words.”
Science Corporation has raised around $490m in total capital since being founded in 2021, with much of the funding devoted to commercialising Prima. The company is headquartered in California with offices in Paris, France.
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