# PRIMA Retinal Implant **Entity class:** Medical device **Domain:** Visual Prostheses / Write-Side Neural Interfaces **Doc Type:** Device Node **Maturity:** Commercial (European Union) **Collection:** [[collections/Neurotech|Neurotech]] **Primary Sources:** [[research/Research Inferences Integration Report - 2026-10-23|Research Inferences Integration Report — 2026-10-23]] ## Definition **PRIMA is [[wiki/Science Corporation|Science Corporation]]'s wireless photovoltaic retinal implant for restoring central vision in geographic atrophy from dry age-related macular degeneration.** It received the CE mark on 22 July 2026, certified by the German notified body DEKRA, authorizing sale across 30 European countries, with the first commercial implantation expected in Germany. Science describes it as a BCI retinal implant; it is the first commercially authorized device in the corpus that *writes* a percept into the nervous system for vision. ## Device and evidence - **Implant:** a 2 × 2 mm wireless chip with 378 photovoltaic pixels placed under the retina. Camera glasses project the scene in near-infrared light onto the chip, which converts it into electrical stimulation of the surviving retinal neurons. - **Pivotal evidence:** the PRIMAvera trial enrolled 38 patients at 17 European centers (open-label, single-group, baseline-controlled); 81% achieved clinically meaningful improvement in visual acuity at 12 months, published in the *New England Journal of Medicine* (2025). - **Durability:** 36-month results presented at the 2026 American Academy of Ophthalmology meeting reported a mean gain of about 30 ETDRS letters; 29 serious adverse events were recorded, 83% of them in the first six months after surgery. - **United States:** FDA Breakthrough Device designation (2023) and Humanitarian Use Device designation; a Humanitarian Device Exemption is required before U.S. marketing. ## Company context Science Corporation, founded by [[wiki/Max Hodak|Max Hodak]] in 2021, closed a $230 million Series C on 5 March 2026 to commercialize PRIMA and extend trials to Stargardt disease and retinitis pigmentosa. Participants included Lightspeed, [[wiki/Khosla Ventures|Khosla Ventures]], Y Combinator, [[wiki/In-Q-Tel|In-Q-Tel]] and Quiet Capital; company-reported total funding is about $490 million since 2021. In-Q-Tel's seat at the commercialization stage places the company beside the national-capability lineage of [[wiki/DARPA N3|DARPA N3]]. ## Forward Capability PRIMA's authorization is the first commercial write channel for vision: a device that installs a percept rather than reads one, sold under an ordinary ophthalmic indication. Its European launch came four months after China's NMPA approved [[wiki/Neuracle|Neuracle]]'s NEO, and both preceded any FDA premarket approval of a BCI. The pixel count and the projected-image architecture make PRIMA a measurable instance of the resolution question INF-0017 poses for cortical prostheses. ## Open Questions - FDA Humanitarian Device Exemption decision and timing. - Reimbursement codes in Germany and the first European payers. - Resolution ceiling: what pixel density the subretinal geometry can support in a second-generation chip. ## Research Inferences These entries translate the forward-looking register in [[research/Research Inferences|Research Inferences]] into ordinary wiki prose. The tier labels apply to the inference, not automatically to every factual anchor inside it. Proposed IDs above INF-0500 and tier recommendations come from the 2026-10-23 cycle: [[research/Research Inferences Integration Report - 2026-10-23|Research Inferences Integration Report — 2026-10-23]] · [[research/Research Inferences Integration Audit - 2026-10-23|Research Inferences Integration Audit — 2026-10-23]]. - **INF-0017 — Plausible.** A cortical visual prosthesis is a write-side experiment wearing a clinical indication: it must install a percept rather than read one. Whatever resolution it achieves is a direct measurement of how much experience can be authored from outside, which is the core uploading question stated in an approvable form. - **INF-0055 — Strongly indicated.** The first PMA for a permanently implanted BCI creates the classification template every subsequent device is measured against. Regulatory precedent is a form of standards authorship, and it is being competed for by a small number of firms on a two-to-three-year horizon. - **INF-0467 — Analytic.** European rules become global operating standards because compliance is cheaper to universalize than to segment. European neural-data classification will therefore govern products sold everywhere, regardless of local law. - **INF-0491 — Analytic.** Every capability in this corpus enters the world through a medical indication because that is the funded, permitted, and reimbursable route. The indication is the carrier wave, and the capability is the signal. - **INF-0506 (proposed) — Strongly indicated.** The first market approval for an implanted BCI and the first commercial CE-marked BCI retinal implant both preceded any FDA premarket approval; the classification template is being written in Beijing and Brussels first. ## Relationships - **product_of:** [[wiki/Science Corporation|Science Corporation]]. - **founder_lineage:** [[wiki/Max Hodak|Max Hodak]] (Neuralink co-founder, Science founder). - **investor_context:** [[wiki/In-Q-Tel|In-Q-Tel]] · [[wiki/Khosla Ventures|Khosla Ventures]] · [[wiki/Lightspeed Venture Partners|Lightspeed Venture Partners]] (Series C, 5 March 2026). - **competing_visual_prosthesis:** [[wiki/Blindsight|Blindsight]] (Neuralink cortical approach; no reported human implant as of 7 October 2026). - **regulatory_peer:** [[wiki/Neuracle|Neuracle]] (first implanted-BCI market approval, China). - **cluster_home:** [[wiki/Neural Interfaces and Continuity Architecture|Neural Interfaces and Continuity Architecture]] (write channel) · [[wiki/Brain-Computer Interfaces|Brain-Computer Interfaces]] · [[collections/Neurotech|Neurotech]]. - **source context:** [[articles/Technologies for Consciousness Mapping and Transfer|Technologies for Consciousness Mapping and Transfer]] (section VIII, the write channel). ## Sources - [Science Corp. Announces European Commercial Launch of PRIMA — Business Wire, 22 July 2026](https://www.businesswire.com/news/home/20260722965902/en/Science-Corp.-Announces-European-Commercial-Launch-of-PRIMA-the-Only-Treatment-to-Restore-Functional-Central-Vision-to-Patients-with-Geographic-Atrophy-Caused-by-Age-Related-Macular-Degeneration-a-Leading-Cause-of-Blindness) - [PRIMA retinal implant receives CE mark — touchOPHTHALMOLOGY, July 2026](https://touchophthalmology.com/insight/prima-retinal-implant-receives-ce-mark-for-vision-restoration-in-geographic-atrophy/) - [Implant restores central vision in GA — Retinal Physician, November/December 2025](https://www.retinalphysician.com/issues/2025/novemberdecember/implant-restores-central-vision-in-ga) - [PRIMAvera 36-month results, 2026 AAO meeting — Retinal Physician](https://retinalphysician.com/issues/2026/aao-retina-subspecialty-day/assessing-primas-efficacy-and-safety-at-36-months/?d=report) - [Science Corporation closes $230 million Series C — Business Wire, 5 March 2026](https://businesswire.com/news/home/20260305896789/en/Science-Corporation-Closes-%24230-Million-Series-C-to-Accelerate-Commercialization-of-Its-PRIMA-BCI-Retinal-Implant-the-Worlds-Most-Advanced-Vision-Restoration-Technology) As of 23 October 2026.