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The BCI Briefing

Regulatory4 min read

A retinal implant becomes the first of the new generation to reach the market

Science Corporation's PRIMA has been CE-marked for geographic atrophy and launched commercially in Europe, on the back of a multicentre trial published in NEJM.

ByThe BCI Briefing

Evidence class: Reported claim

The short version

  • PRIMA received a CE mark for geographic atrophy due to age-related macular degeneration.
  • In the pivotal study, 26 of 32 participants assessed at one year had a clinically meaningful gain in visual acuity.
  • The device is not authorised in the United States.

Science Corporation announced the European commercial launch of PRIMA on 22 July, following CE marking under the EU Medical Device Regulation. The company says the mark allows distribution across 30 European countries and expects the first commercial implantation in Germany.

PRIMA is a wireless photovoltaic chip placed under the retina. Glasses with a camera project near-infrared images onto it, and the chip stimulates the remaining retinal neurons.

How solid is this

The launch and CE mark are company reported; we identified the release through search and did not open the release itself. The clinical evidence is peer reviewed: 38 participants implanted, 32 assessed at 12 months, 26 (81%) improved by at least 0.2 logMAR (Holz et al., NEJM). The study was open-label and single-group. Serious adverse events related to the procedure or device were reported and are detailed in the paper.

Company reported. Stated by the company itself in a release, blog post or presentation. Not independently verified and usually without full methods.

What to watch

  1. 01A regulatory decision in the United States, where discussions with the FDA were described as ongoing in March.
  2. 02Real-world outcomes and device durability after commercial implantation.
  3. 03Reimbursement decisions country by country.

Sources

  1. 01

    Science Corp. Announces European Commercial Launch of PRIMA (opens in a new tab)

    Company reportedScience Corporation press release (Business Wire)22 Jul 2026Source identified, not opened

    Identified through search; the release itself was not opened.

  2. 02

    Science Corp. raises $230M as it races to bring its brain implant to market (opens in a new tab)

    Independent reportingTechCrunch5 Mar 2026Checked against source 3 Oct 2026

  3. 03

    Holz FG et al. N Engl J Med 2026;394(3):232–242 (opens in a new tab)

    Peer reviewedNew England Journal of Medicine20 Oct 2025Checked against source 3 Oct 2026

    DOI 10.1056/NEJMoa2501396

  4. 04

    ClinicalTrials.gov NCT04676854 (opens in a new tab)

    Clinical registryClinicalTrials.gov1 Jun 2026Checked against source 3 Oct 2026

    Registry record last updated 2026-06-01.