{"id":8531,"date":"2026-07-27T10:24:39","date_gmt":"2026-07-27T10:24:39","guid":{"rendered":"https:\/\/intnews.it\/?p=8531"},"modified":"2026-07-27T10:48:53","modified_gmt":"2026-07-27T10:48:53","slug":"prima-retinal-implant","status":"publish","type":"post","link":"https:\/\/intnews.it\/en\/prima-retinal-implant\/","title":{"rendered":"PRIMA Retinal Implant Gets CE Mark to Restore Vision in Macular Degeneration Patients"},"content":{"rendered":"\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<iframe width=\"100%\" height=\"100%\"src=\"https:\/\/iframe.mediadelivery.net\/embed\/511677\/79ab2828-7baf-4be5-8122-1309cb764358\" loading=\"lazy\" allow=\"accelerometer;gyroscope;encrypted-media;picture-in-picture;\" allowfullscreen=\"true\"><\/iframe>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>Key points<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong>PRIMA retinal implant<\/strong> has received CE marking. It is the first device authorised in Europe to restore functional central vision in patients with advanced geographic atrophy (dry macular degeneration).<\/li>\n\n\n\n<li>The CE mark allows sales in 30 European countries. The first commercial implant will soon take place in Germany. Reimbursement procedures are already underway.<\/li>\n\n\n\n<li>The system combines a subretinal photovoltaic microchip (2&#215;2 mm) with glasses that project infrared light. Peripheral vision remains untouched.<\/li>\n\n\n\n<li>A study in the <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC7618305\/\">New England Journal of Medicine<\/a> followed 38 patients across 17 European centres. 84% of participants regained the ability to read letters, numbers and words after 12 months.<\/li>\n\n\n\n<li>Italy is taking part in the trial through the University of Rome Tor Vergata, together with the San Giovanni Addolorata Hospital. The Roman centre aims to train other Italian hospitals.<\/li>\n\n\n\n<li>Science Corp is also working with the FDA to bring the device to the United States. It has already received Breakthrough Device and Humanitarian Use Device designations.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">A breakthrough millions of patients have been waiting for<\/h2>\n\n\n\n<p>Millions of people live with one of the leading causes of irreversible blindness in the Western world. Today, they finally have a concrete answer: the <strong>PRIMA retinal implant<\/strong>.<\/p>\n\n\n\n<p>PRIMA is the retinal implant developed by the California-based company Science Corp. The device has received CE marking, the certification required under the European Medical Device Regulation. This approval authorises the sale of the PRIMA retinal implant in 30 European countries.<\/p>\n\n\n\n<p>It is the first brain-computer interface device to receive this authorisation for restoring central vision. The condition it treats is called advanced dry macular degeneration, also known as geographic atrophy.<\/p>\n\n\n\n<p>Readers interested in how biomedical research is reshaping healthcare can also check INT News&#8217;s feature on <a href=\"https:\/\/intnews.it\/en\/category\/interviews\/\">innovation and interviews with the people building tomorrow&#8217;s technology<\/a>, a series exploring the founders and researchers behind emerging medical technologies.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">A disease with no cure until now<\/h3>\n\n\n\n<p>Geographic atrophy is linked to age-related macular degeneration. It is the leading cause of irreversible blindness worldwide and affects more than 5 million people.<\/p>\n\n\n\n<p>The disease gradually destroys photoreceptors in the central part of the retina. This damage compromises essential daily activities: reading, recognising faces, moving around safely. In advanced stages, it can lead to complete blindness in the central visual field. Peripheral vision, however, often remains partially preserved.<\/p>\n\n\n\n<p>Until now, no therapy existed that could restore lost vision. Available treatments only slow the disease&#8217;s progression, often through monthly or bimonthly intravitreal injections.<\/p>\n\n\n\n<p>In Italy alone, an estimated 850,000 patients live with the atrophic form of macular degeneration. For them, before the PRIMA retinal implant, no effective treatment option existed.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">How the PRIMA retinal implant works<\/h2>\n\n\n\n<p>PRIMA combines two elements that work together: a subretinal photovoltaic microchip and a dedicated pair of glasses.<\/p>\n\n\n\n<p>The microchip measures just 2&#215;2 millimetres and is about 30 microns thick, roughly a third the width of a human hair. The glasses house a camera that captures images of the surrounding environment. This camera projects the images as near-infrared light directly onto the microchip implanted beneath the retina.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">From electrical pulses to reading again<\/h3>\n\n\n\n<p>The chip converts these light signals into electrical pulses. These pulses stimulate the retinal cells that still function, which then transmit visual information to the brain through the optic nerve.<\/p>\n\n\n\n<p>In practice, the device replaces the photoreceptors lost in the central retina. The patient regains a visual perception useful for reading letters, numbers and words. The system also includes a magnification function: patients can enlarge text to make reading easier. Natural peripheral vision remains untouched throughout the process.<\/p>\n\n\n\n<p>Surgeons implant the microchip through vitrectomy, a minimally invasive procedure. The operation takes about ninety minutes and is usually performed under local anaesthesia.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Results from the international clinical trial<\/h2>\n\n\n\n<p>The New England Journal of Medicine published a multicentre study on the effectiveness of the PRIMA retinal implant. The study involved 38 patients across 17 clinical centres in France, Germany, the United Kingdom, the Netherlands and Italy.<\/p>\n\n\n\n<p>The trial is part of the international PRIMAvera project. Reference centres include the University of Rome Tor Vergata, working alongside the <a href=\"https:\/\/www.ansa.it\/canale_saluteebenessere\/notizie\/medicina\/2022\/09\/13\/retina-artificiale-primo-impianto-in-italia-per-maculopatia_c8ac9e8c-4ec0-46b7-9cb6-484d7b39efea.html\">San Giovanni Addolorata Hospital in Rome<\/a>.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Outcomes after twelve months<\/h3>\n\n\n\n<p>After twelve months of follow-up, 84% of patients regained the ability to read letters, numbers and words. 80% also showed a significant improvement in prosthetic visual acuity.<\/p>\n\n\n\n<p>An equally important finding concerns safety. The study confirms that the implant does not damage patients&#8217; remaining natural vision. This is a crucial point: many patients still retain some degree of peripheral visual function.<\/p>\n\n\n\n<p>PRIMA&#8217;s development began with the French company Pixium Vision, which specialised in electronic systems for vision restoration. Science Corp later acquired the project. The company, founded in 2021 in Alameda, California, also has offices in Paris and has raised around $490 million to date.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">What&#8217;s next in Europe and the United States<\/h2>\n\n\n\n<p>With CE marking secured, Science Corp can immediately begin selling the PRIMA retinal implant across 30 European countries. The company has already started national procedures for treatment reimbursement and for activating clinical centres. The first commercial implant is expected soon in Germany.<\/p>\n\n\n\n<p>At the same time, Science Corp is working with the US Food and Drug Administration to bring the device to the United States. PRIMA has already received Breakthrough Device and Humanitarian Use Device designations. These designations guarantee accelerated review pathways for medical devices treating rare conditions.<\/p>\n\n\n\n<p>Innovation in clinical care is evolving across other areas of medicine too, as explored in INT News&#8217;s broader coverage on <a href=\"https:\/\/intnews.it\/en\/\">emerging technology<\/a>, which regularly features stories on how new devices and treatments are reshaping healthcare.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Voices from the field<\/h2>\n\n\n\n<p>Max Hodak, CEO of Science Corp, commented on the milestone with pride: &#8220;We are the first company in the brain-computer interface space to receive CE marking for a device that restores detailed shape vision. Until now, losing central vision to this disease meant losing the ability to read, recognise faces, and ultimately, personal independence. No effective treatment existed. Now it does.&#8221;<\/p>\n\n\n\n<p>Frank Holz heads the Department of Ophthalmology at the University Hospital of Bonn and is the lead author of the study published in the New England Journal of Medicine. Holz emphasises that clinical trials show a clear result: the PRIMA retinal implant restores central vision in patients with geographic atrophy, who go on to read letters, numbers and words again.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">The Italian perspective: Andrea Cusumano<\/h3>\n\n\n\n<p>Andrea Cusumano teaches Ophthalmology at the University of Rome Tor Vergata and coordinates the Italian arm of the clinical trial. Cusumano highlights the technology&#8217;s social impact: thousands of patients will be able to leave forced visual isolation behind and return to reading and moving confidently through their surroundings.<\/p>\n\n\n\n<p>Treatment success depends on three key factors, Cusumano explains: correct patient selection, flawless surgical execution, and post-implant visual rehabilitation. He compares this process to an athlete&#8217;s recovery after an injury: without rehabilitation, a player who has had knee surgery never returns to their previous competitive level. That is why highly specialised centres are essential. The hope is that, alongside Tor Vergata, other Italian centres will be trained to perform the procedure, following the training model already established in Rome.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">A paradigm shift in treating macular degeneration<\/h2>\n\n\n\n<p>The PRIMA retinal implant does not cure macular degeneration and does not stop the disease from progressing. The device replaces, where possible, the function of damaged photoreceptors. Patients regain a partial but functionally meaningful visual perception.<\/p>\n\n\n\n<p>Still, this result marks an important paradigm shift. Until now, medicine only had therapies to slow the disease, not solutions to restore vision that had already been lost.<\/p>\n\n\n\n<p>With CE marking in hand, the technology now enters a new phase of clinical rollout across Europe. Italy, already a protagonist in the trial phase, is positioned to lead this next stage of adoption among real-world patients.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Key points A breakthrough millions of patients have been waiting for Millions of people live with one of the leading causes of irreversible blindness in the Western world. Today, they&#8230;<\/p>\n","protected":false},"author":6,"featured_media":8527,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[84],"tags":[],"class_list":{"0":"post-8531","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-technologies"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>PRIMA Retinal Implant Gets CE Mark to Restore Vision in Macular Degeneration Patients - INT News PRIMA Retinal Implant: CE Mark for Macular Disease<\/title>\n<meta name=\"description\" content=\"Key points The PRIMA retinal implant has received CE marking. It is the first device authorised in Europe to restore functional central vision in patients The PRIMA retinal implant is the first CE-marked device that restores central vision in patients with macular degeneration. Here&#039;s how it works.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/intnews.it\/en\/prima-retinal-implant\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PRIMA Retinal Implant Gets CE Mark to Restore Vision in Macular Degeneration Patients - INT News PRIMA Retinal Implant: CE Mark for Macular Disease\" \/>\n<meta property=\"og:description\" content=\"Key points The PRIMA retinal implant has received CE marking. It is the first device authorised in Europe to restore functional central vision in patients The PRIMA retinal implant is the first CE-marked device that restores central vision in patients with macular degeneration. 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It is the first device authorised in Europe to restore functional central vision in patients The PRIMA retinal implant is the first CE-marked device that restores central vision in patients with macular degeneration. 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