PARIS–(BUSINESS WIRE)–Regulatory News:
Pixium Eyes (Paris:PIX) (FR0011950641 – PIX), a aggregation developing avant-garde bionic eyes systems to acquiesce patients who accept absent their afterimage to advance added absolute lives, appear today that it has accustomed approval from the Spanish Ministry of Health for analytic balloon with the IRIS®II bionic eyes arrangement for patients who accept absent afterimage due to Retinitis Pigmentosa (RP). The IRIS®II arrangement appearance accommodate a mini bio-inspired camera and a 150-electrode epi-retinal implant with an explantable design.
Barcelona’s Institute of Ocular Microsurgery IMO (Spain) joins the accretion arrangement of centres of arete in Europe1 complex in the analytic balloon with IRIS®II. The Institute of Ocular Microsurgery is a apple acclaimed ophthalmology centermost committed to the analysis of ocular diseases and the alteration of vision. Patients in Spain will accept the befalling to participate in this European analytic trial.
Prof. Borja Corcostegui, Founder and Medical Director of the Institute of Ocular Microsurgery, IMO, a vitroretinal surgeon and the trial’s arch investigator in Spain said: “We are captivated to participate in the analytic balloon with IRIS®II and become the aboriginal armpit in Spain. Patients dark from alien retinal decline in Spain can accede accord in assessing the avant-garde bionic eyes arrangement advised to achieve a anatomy of beheld perception. Accord in analytic trials with avant-garde analysis options is capital for ophthalmology advertence centres such as IMO. The affiliation with Pixium Eyes to advance solutions for retinal dystrophies, such as RP and, in the a future, Age-related Macular Decline (AMD), is constant with our connected charge to action cutting-edge analysis options to our patients.”
Khalid Ishaque, CEO of Pixium Eyes said: “The approval of the analytic balloon now in Spain reinforces our aplomb in the IRIS®II, our aboriginal bionic eyes system. Today, Pixium Eyes is the alone aggregation developing an epi-retinal implant arrangement for retinitis pigmentosa, and a sub-retinal wireless photovoltaic implant for AMD patients. We are appreciative to admit this analytic accord in Spain with the internationally acclaimed Institute of Ocular Microsurgery, IMO.”
In July 2016, Pixium Eyes additionally accustomed EU bazaar approval for IRIS®II. Available beneath medical prescription, the bionic eyes arrangement offers a new analysis advantage to patients with retinitis pigmentosa. The Aggregation can now additionally accompany agreement with the civic healthcare systems. The advancing -to-be multi-centre analytic abstraction agreement actuality conducted beyond several European ophthalmology advertence centres, added enables architecture best appellation affirmation for the arrangement performance.
IRIS®II incorporates avant-garde and characteristic features:
About IMO Barcelona
IMO (Institute of Ocular Microsurgery) is a arch all-embracing ophthalmology centre, committed to medical arete with the cold of accouterment the best account to the patient. For over 25 years, the Institute has approved to acquisition solutions to all ocular disorders through the able appliance of avant-garde technology and techniques.
On-going training and research, accommodating actively in analytic trials, accredit IMO to ascertain new ameliorative opportunities and accomplish advances in the analytic and analysis of eye problems in a beat and able manner.
Its new premises, inaugurated in 2009 and boasting 70 consulting apartment and 8 operating theatres in an breadth of 22.000 aboveboard meters, accept accustomed IMO to become one of the better and best avant-garde centers in Europe. However, its authentication is the medical team, led by 20 ophthalmologists sub-specialized in anniversary allotment of the eye and the accompanying pathologies. http://www.imo.es/en/
About the IRIS®II analytic abstraction
Abstraction title: “Compensation for Amaurosis with the Intelligent Retinal Implant Arrangement (IRIS V2) in Patients With Retinal Dystrophy (IRIS 2)” https://www.clinicaltrials.gov Ref: NCT02670980.
The IRIS®II analytic balloon is a multi-centric, accessible label, non-randomized -to-be European abstraction to appraise assurance and achievement of the IRIS®II bionic eyes arrangement as analysis to atone for blindness, accouterment a anatomy of acumen for dark bodies and enabling them greater freedom and affection of living.
Up to 10 patients adversity from retinitis pigmentosa, Usher Syndrome, Cone-Rod dystrophy, choroideremia will be included and followed for a minimum of 18 months, with added 18 months follow-up, accountable to accommodating consent.
Analytic trials are currently underway beyond assorted European centers:
About CE mark
CE appearance allows companies to accurately bazaar and administer articles aural the European bazaar and declares the artefact complies with all applicative European Directives and Regulations. For Active Implantable Medical Devices (AIMDs) like IRIS®II, CE Appearance is accepted by a Notified Body afterwards analysis of architecture abstracts and added advice for acquiescence to the AIMD Directive. Following CE Marking, a artefact can be awash in the EEA, and assertive added countries.
About Retinitis Pigmentosa (RP)
Retinitis Pigmentosa is the best accepted account of affiliated amaurosis with a prevalence of about 1.5 actor bodies worldwide. In these patients, the decline of retinal beef generally begins in their boyhood age years and the absolute accident of eyes occurs in their 40s. It is estimated that in Europe and the North America, about 350 000 to 400 000 bodies are afflicted by RP and that
15 000 to 20 000 new patients with RP lose their afterimage anniversary year.
PRIMA is the additional arrangement developed by the company. This tiny wireless photovoltaic sub-retinal implant has a modular anatomy and is currently in pre-clinical development. The aggregation affairs to barrage analytic trials of PRIMA in Europe in 2016.
About Pixium Eyes ( www.pixium-vision.com ; @PixiumVision; www.facebook.com/pixiumvision)
Pixium Vision’s Mission is to actualize a apple of bionic eyes for those who accept absent their afterimage enabling them to achieve fractional beheld acumen and greater autonomy. Pixium Vision’s bionic eyes systems are associated with a surgical action as able-bodied as a rehabilitation period. They aim to accredit patients who accept absent their afterimage to advance added absolute lives.
The aggregation has acquired the CE mark for IRIS®II, its aboriginal bionic system, in July 2016.
Pixium Eyes is, in parallel, developing PRIMA, a sub-retinal miniaturized wireless photovoltaic implant belvedere for Age-related Macular Decline (AMD) indication. PRIMA is currently in preclinical studies. The aggregation affairs to activate analytic trials with PRIMA in Europe in 2016.
The aggregation is EN ISO 13485 certified.
Pixium Eyes collaborates carefully with bookish and analysis ally spanning beyond the celebrated Eyes analysis institutions including the Institut de la Eyes in Paris, the Hansen Experimental Physics Laboratory at Stanford University, and Moorfields Eye Hospital in London.
Pixium Eyes is listed on Euronext (Compartiment C) in Paris.
ISIN: FR0011950641; Mnemo: PIX
IRIS® is a brand of Pixium-Vision SA
This columnist absolution may especially or around accommodate advanced statements apropos to Pixium Eyes and its activity. Such statements are accompanying to accepted or alien risks, uncertainties and added factors that could advance absolute results, banking conditions, achievement or achievements to alter materially from Eyes Pixium results, banking conditions, achievement or achievements bidding or adumbrated by such advanced attractive statements.
Pixium Eyes provides this columnist absolution as of the above date and does not accomplish to amend advanced attractive statements independent herein, whether as a aftereffect of new information, approaching contest or otherwise.
For a description of risks and uncertainties which could advance to discrepancies amid absolute results, banking condition, achievement or achievements and those independent in the advanced statements, amuse accredit to Chapter 4 “Risk Factors” of the company’s Registration Document filed with the AMF beneath cardinal R16-033 on April 28, 2016 which can be begin on the websites of the AMF – AMF (www.amf-france.org) and of Pixium Eyes (www.pixium-vision.com).
1 Analytic balloon in European centres: http://www.pixium-vision.com/fr/essai_clinique/participating-centers
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