{"id":8531,"date":"2026-07-27T10:24:39","date_gmt":"2026-07-27T10:24:39","guid":{"rendered":"https:\/\/intnews.it\/?p=8531"},"modified":"2026-10-22T14:52:57","modified_gmt":"2026-10-22T14:52:57","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 the CE mark. It is the first device cleared in Europe to give back useful central sight to people with advanced geographic atrophy (dry macular degeneration).<\/li>\n\n\n\n<li>The CE mark allows sales in 30 European countries. The first paid implant will soon take place in Germany. Steps to get costs refunded are already under way.<\/li>\n\n\n\n<li>The system pairs a tiny solar chip (2&#215;2 mm) placed under the retina with glasses that beam infrared light. Side vision stays as it is.<\/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 in 17 European centres. After 12 months, 84% of them could read letters, numbers and words again.<\/li>\n\n\n\n<li>Italy takes part in the trial through the University of Rome Tor Vergata, with the San Giovanni Addolorata Hospital. The Rome 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 US. It has already been named a Breakthrough Device and a Humanitarian Use Device.<\/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 a retinal implant made by Science Corp, a company based in California. It has received the CE mark, which the EU Medical Device Regulation requires. This lets the PRIMA implant be sold in 30 European countries.<\/p>\n\n\n\n<p>It is the first brain-computer interface device to get this approval to restore central sight. The disease it treats is called advanced dry macular degeneration, also known as geographic atrophy.<\/p>\n\n\n\n<p>Want to know how medical research is changing healthcare? Read INT News\u2019s series on <a href=\"https:\/\/intnews.it\/en\/category\/interviews\/\">innovation and interviews with the people building tomorrow&#8217;s technology<\/a>. It looks at the founders and researchers behind new medical tech.<\/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 main cause of lasting blindness in the world. It affects more than 5 million people.<\/p>\n\n\n\n<p>The disease slowly kills the light-sensing cells in the centre of the retina. This harms basic daily tasks: reading, knowing faces, moving around safely. In late stages, it can cause full blindness in the centre of the field of view. Side vision, though, often stays in part.<\/p>\n\n\n\n<p>Until now, no treatment could bring back lost sight. Current treatments only slow the disease, often with injections into the eye every one or two months.<\/p>\n\n\n\n<p>In Italy alone, about 850,000 people live with the dry form of macular degeneration. Before the PRIMA implant, there was no treatment that worked for them.<\/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 has two parts that work together: a tiny solar chip placed under the retina and a special pair of glasses.<\/p>\n\n\n\n<p>The chip is just 2&#215;2 millimetres in size and about 30 microns thick. That is about a third of the width of a human hair. The glasses hold a camera that films what is around you. The camera beams these images as near-infrared light onto the chip under 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 turns this light into small electric pulses. The pulses wake up the retinal cells that still work. These cells then send the image to the brain through the optic nerve.<\/p>\n\n\n\n<p>In practice, the device takes the place of the lost light-sensing cells in the centre of the retina. The patient can see well enough to read letters, numbers and words. The system can also zoom: patients can make text bigger to read it more easily. Natural side vision is not touched at any point.<\/p>\n\n\n\n<p>Surgeons place the chip through vitrectomy, a gentle procedure with only small cuts. The operation takes about ninety minutes. It is usually done under local anaesthetic.<\/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 study on how well the PRIMA implant works. It involved 38 patients in 17 clinics in France, Germany, the UK, 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, 84% of patients could read letters, numbers and words again. 80% also saw much more sharply with the implant.<\/p>\n\n\n\n<p>Safety is just as important. The study shows that the implant does not harm the natural sight that patients still have. This is key, because many patients still have some side vision.<\/p>\n\n\n\n<p>PRIMA was first developed by the French firm Pixium Vision, which made electronic systems to restore sight. Science Corp later bought the project. The company was founded in 2021 in Alameda, California. It also has offices in Paris and has raised about $490 million so far.<\/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 the CE mark in hand, Science Corp can start selling the PRIMA implant right away in 30 European countries. It has already begun national steps to get the treatment refunded and to set up clinics. The first paid 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 US. PRIMA has already been named a Breakthrough Device and a Humanitarian Use Device. These labels give a faster review to medical devices for rare diseases.<\/p>\n\n\n\n<p>New ideas are changing other areas of medicine too. INT News covers them in its wider reporting on <a href=\"https:\/\/intnews.it\/en\/\">emerging technology<\/a>, with regular stories on how new devices and treatments are changing 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 Eye Department at the University Hospital of Bonn. He is the lead author of the study in the New England Journal of Medicine. Holz stresses that the trials show a clear result. The PRIMA implant gives back central sight to people with geographic atrophy. They can 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 eye medicine at the University of Rome Tor Vergata. He leads the Italian part of the trial. Cusumano points to the social impact of the tech. Thousands of patients will be able to leave behind the isolation of poor sight. They will read again and move around with confidence.<\/p>\n\n\n\n<p>Cusumano explains that success depends on three things: picking the right patients, perfect surgery and sight training after the implant. He compares it to an athlete coming back from an injury. Without rehab, a player who has had knee surgery never gets back to their old level. That is why highly skilled centres are vital. The hope is that other Italian centres will be trained to do the procedure, following the model already set up 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 implant does not cure macular degeneration. It does not stop the disease from getting worse. Where it can, the device takes over the job of the damaged light-sensing cells. Patients get back part of their sight, enough to be truly useful.<\/p>\n\n\n\n<p>Still, this is a big shift. Until now, medicine could only slow the disease. It had no way to bring back sight that was already lost.<\/p>\n\n\n\n<p>With the CE mark, the tech now enters a new phase as it rolls out in clinics across Europe. Italy already played a lead role in the trial. It is now well placed to lead the next step: use with real 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":"closed","ping_status":"closed","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 v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>PRIMA Retinal Implant Gets CE Mark - INT News<\/title>\n<meta name=\"description\" content=\"The PRIMA retinal implant is the first CE-marked device that restores central vision in patients with macular degeneration. 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