{"id":472350,"date":"2021-04-07T01:03:10","date_gmt":"2021-04-07T05:03:10","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=472350"},"modified":"2021-04-07T01:03:10","modified_gmt":"2021-04-07T05:03:10","slug":"pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/","title":{"rendered":"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <strong>Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera<\/strong>\n      <\/p>\n<ul type=\"disc\">\n<li>Study is the last clinical step before seeking market approval in Europe in dry AMD<\/li>\n<li>Bionic vision Prima System has shown excellent results in improving vision<\/li>\n<\/ul>\n<p>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<strong>\u00a0<\/strong><\/p>\n<p align=\"justify\">\n        <strong>Paris, France, April 7, 2021<\/strong> \u2013 7.00 a.m. CEST \u2013 Pixium Vision SA (Euronext Growth Paris &#8211; FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces the successful first implantation of a patient in the PRIMAvera pivotal trial of its bionic vision Prima System for atrophic dry age-related macular degeneration (AMD).<\/p>\n<p align=\"justify\">The PRIMAvera study was initiated in Q4 2020 and aims to confirm the safety and the benefits provided by the Prima System and is the last clinical step before seeking market approval in Europe.<\/p>\n<p align=\"justify\">\n        <em>\u201cThis first successful implantation in the PRIMAvera pivotal trial is an important milestone for the Prima System and for patients suffering from dry AMD. The Prima System has shown very encouraging results so far and I am looking forward to seeing confirmation of these life changing effects in dry AMD,\u201d<\/em> said <strong>Dr Yannick Le Mer, Deputy Head of Vitreo-retinal Unit at Fondation Adolphe de Rothschild Hospital in Paris and Coordinating Investigator of the study.<\/strong><\/p>\n<p align=\"justify\">The PRIMAvera study design is based on the positive data generated in a French feasibility study, showing the ability of patients with dry AMD to improve in visual acuity with the Prima System. Patients had a significant improvement in vision, gaining on average a logMAR of 0.5 (corresponding to 5 lines improvement).<\/p>\n<p align=\"justify\">A total of 38 patients will be enrolled in PRIMAvera, an open label, baseline-controlled, nonrandomized, multi-center, prospective, single-arm confirmatory trial. The primary efficacy endpoint is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 month and the primary safety endpoint is the number and severity of device and procedure related serious adverse events at 12 months follow-up. The study will include three years of follow-up, with assessment of the primary endpoints at 12 months after implantation.<\/p>\n<p align=\"justify\">\n        <em>\u201cPixium Vision continues to deliver on its transition from a research organization to a commercial one. This first implantation makes us a step closer to getting our highly innovative and exciting Prima System on the market and to the patients who are in desperate need,\u201d <\/em>said <strong>Lloyd Diamond, Chief Executive Officer of Pixium Vision<\/strong><em>. \u201cThe Prima System has demonstrated excellent results in improving vision which will correlate to their ability to undertake day-to-day tasks, and has the potential to make a significant difference in the quality of life of patients suffering from dry AMD, who currently have no treatment options.\u201d<\/em><\/p>\n<p align=\"justify\">In addition to the ongoing PRIMAvera study, Pixium Vision expects to report 36-month data from the French feasibility study by end 2021 \/ beginning 2022, and continues clinical development in the US.<\/p>\n<p align=\"justify\">\n        <strong>ABOUT PIXIUM VISION<\/strong>\n      <\/p>\n<p align=\"justify\">Pixium Vision\u2019s mission is to create a world of bionic vision for those who have lost their sight, enabling them<\/p>\n<p align=\"justify\">to regain partial visual perception and greater autonomy. Pixium Vision\u2019s bionic vision systems are associated<\/p>\n<p align=\"justify\">with a surgical intervention and a rehabilitation period.<\/p>\n<p align=\"justify\">Pixium Vision is conducting clinical feasibility studies of its Prima system, its miniaturised wireless sub-retinal<\/p>\n<p align=\"justify\">implant, in patients who have lost their sight due to retinal degeneration associated with the dry form of AgeRelated Macular Degeneration (AMD). Pixium Vision works closely with world-renown academic partners, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, USA. The company is EN ISO 13485 certified. Pixium Vision has been qualified as an \u201cInnovative Company\u201d by Bpifrance.<\/p>\n<p align=\"justify\">For more information: \u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=es8NLpxHKzrMG7iUvWNsJIbghfHu21ewEYhtBuMltvuVbGspUPOuUvPYVshi83su3BRQh72tEbrVyutpHw1UsCVDWXkaqXC6DrMavz6F8bPc_GNjqZgpocootDKYWfEw\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">http:\/\/www.pixium-vision.com\/fr<\/a><\/p>\n<p align=\"justify\">Follow us on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Ho3KZYKz7TCX6TkjtBSZOWdIt_c3lS3fK1ILw0yw7i9TAvODnOuDP9Xse-yTEuNfc_-KEZfvGAspX06nMHT6B6iHcNgvhnHmhmz2yIFGS-c=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">@PixiumVision<\/a>; \u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zLBJV6qfgSO0Ko0-YR5exKmKOIjmnHNYWzYXPthcrl1OFlEaZIr9BAKYLA2kruyZQ6ohZdWEA9hRp2pogPZ9WsrLBeCZdAVp6j9c9GlD5qEnuwK8-Q0a-fzgGWTk5XrK\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.facebook.com\/pixiumvision<\/a><\/p>\n<p align=\"justify\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zLBJV6qfgSO0Ko0-YR5exP4tVXxKxOdUFsw-vSoiZrSUjL0YN7fiLVZ6Ji83E29JWEFhS30nQvjq5IzLW0GbJxKCN0xAU_yiTJm9UjIz-zjl3ZE5jP8ODpDgH1l569TikHuc0o6SuDs9uK7ZTncMjg==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.linkedin.com\/company\/pixium-vision<\/a>\u00a0<\/p>\n<p align=\"justify\">\n        \n      <\/p>\n<p align=\"justify\">\n        \n      <\/p>\n<p>\n        <strong>Contacts<\/strong>\n      <\/p>\n<table style=\"border-collapse: collapse;margin-left:0;width:488.35pt;border-collapse:collapse\">\n<tr>\n<td style=\"width:208.4px;text-align: justify;vertical-align: middle;vertical-align: top\">\n            <strong>Pixium Vision<\/strong><br \/>\n            <br \/>Guillaume Renondin<br \/>Chief Financial Officer<br \/><a href=\"mailto:investors@pixium-vision.com\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>investors@pixium-vision.com<\/u><\/a><br \/>+33 1 76 21 47 68<\/td>\n<td style=\"width:205.8px;vertical-align: top\">\n            <strong>Media relations <\/strong><\/p>\n<p>            <strong>LifeSci Advisors<\/strong><br \/>\n            <br \/>Sophie Baumont<br \/><u>sophie@lifesciadvisors.com<\/u><br \/>+33 6 27 74 74 49<\/td>\n<td style=\"width:236.94px;vertical-align: top\">\n            <strong>Investor relation<\/strong><br \/>\n            <br \/>\n            <strong>LifeSci Advisors<\/strong><br \/>\n            <br \/>Guillaume van Renterghem<br \/><u>gvanrenterghem@lifesciadvisors<\/u><u>.com<\/u><br \/>+41 76 735 01 31<\/td>\n<\/tr>\n<\/table>\n<p \/>\n<p id=\"gnw_attachments_section-header\">\n        <strong>Attachment<\/strong>\n      <\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li>\n          <a target=\"_blank\" href=\"https:\/\/ml-eu.globenewswire.com\/Resource\/Download\/ead28857-68ca-414f-b51b-0050717a1cca\" rel=\"noopener noreferrer\">2021-04-07- Pixium_PRIMAvera First mplantation docx clean &#8211; EN <\/a>\n        <\/li>\n<\/ul>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMDQ3Njc4OCM0MDA5MDcwMTcjMjEyMjg0OA==\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml-eu.globenewswire.com\/release\/track\/9628f644-fb8c-4fa7-ba57-df32c852840b\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera Study is the last clinical step before seeking market approval in Europe in dry AMD Bionic vision Prima System has shown excellent results in improving vision \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Paris, France, April 7, 2021 \u2013 7.00 a.m. CEST \u2013 Pixium Vision SA (Euronext Growth Paris &#8211; FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces the successful first implantation of a patient in the PRIMAvera pivotal trial of its bionic vision Prima System for atrophic dry age-related macular degeneration (AMD). The PRIMAvera study was initiated in Q4 2020 and aims to confirm the safety &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-472350","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera Study is the last clinical step before seeking market approval in Europe in dry AMD Bionic vision Prima System has shown excellent results in improving vision \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Paris, France, April 7, 2021 \u2013 7.00 a.m. CEST \u2013 Pixium Vision SA (Euronext Growth Paris &#8211; FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces the successful first implantation of a patient in the PRIMAvera pivotal trial of its bionic vision Prima System for atrophic dry age-related macular degeneration (AMD). 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/","og_locale":"en_US","og_type":"article","og_title":"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera - Market Newsdesk","og_description":"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera Study is the last clinical step before seeking market approval in Europe in dry AMD Bionic vision Prima System has shown excellent results in improving vision \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Paris, France, April 7, 2021 \u2013 7.00 a.m. CEST \u2013 Pixium Vision SA (Euronext Growth Paris &#8211; FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces the successful first implantation of a patient in the PRIMAvera pivotal trial of its bionic vision Prima System for atrophic dry age-related macular degeneration (AMD). The PRIMAvera study was initiated in Q4 2020 and aims to confirm the safety &hellip; Continue reading \"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/","og_site_name":"Market Newsdesk","article_published_time":"2021-04-07T05:03:10+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMDQ3Njc4OCM0MDA5MDcwMTcjMjEyMjg0OA==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera","datePublished":"2021-04-07T05:03:10+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/"},"wordCount":682,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMDQ3Njc4OCM0MDA5MDcwMTcjMjEyMjg0OA==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/pixium-vision-announces-first-patient-successful-implantation-in-prima-system-pivotal-trial-primavera\/","name":"Pixium Vision announces first patient successful implantation in Prima System pivotal trial PRIMAvera - 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