PARIS & BARCELONA, Spain--(BUSINESS WIRE)--Regulatory News:
Pixium Vision (Paris:PIX), a company developing innovative bionic vision systems with the intention to enable patients who have lost their sight to lead more independent lives, announces the first implantation and activation of IRIS® II in Spain. This implantation is part of Pixium Vision’s ongoing multi-centre clinical trial to assess the performance of IRIS® II which is supposed to provide a treatment to compensate for blindness. The 150 electrode epi-retinal implant is intended for patients who have lost their sight as a result of retinitis pigmentosa (RP).
This marks the first implant of IRIS® II in Spain, a procedure performed by Prof. Borja Corcostegui, Founder and Medical Director of the Institute of Ocular Microsurgery (IMO). Dr. Borja is a vitroretinal surgeon, and the trial’s principal investigator in Spain. The IMO is one of the clinical centres participating in the multicentre European study across France, Germany and Austria, UK and Spain. IMO is a renowned ophthalmology centre dedicated to the treatment of ocular diseases and the correction of vision.
Prof. Corcostegui commented: “This IRIS® II retinal implant was completed for a 75 year old RP patient for the first time in Spain. The 150 electrode implant, with a design intended to be explantable, is an innovative option for retinal surgeons.” He added: “The patient’s system was activated and he reported first perception of light. Per clinical protocol, the patient will now enter training and re-education which is supposed to help with the necessary learning how to interpret these new light signals.”
After the activation and first light perception, some visual perception may become available. Now, the normal re-adaptation and re-education process follows where, per protocol, the patient shall enter a learning process which is supposed to help interpreting the new, artificial form of bionic vision. This artificial form of bionic vision is very different to the natural form of vision and still has to be evaluated.
Khalid Ishaque, CEO of Pixium, added: "The first IRIS® II implant in Spain supports the company’s mission to expand a presence across centres of excellence in Europe. Pixium Vision’s mission is dedicated to the research, development and commercialization of bionic vision systems for patients who have lost sight to retinal dystrophies.”
In parallel, the company continues the development of its second system, PRIMA, a tiny wireless sub-retinal implant. After first preclinical studies, an application for a feasibility study was submitted to regulatory bodies.
About IMO Barcelona
IMO (Institute of Ocular Microsurgery) is committed to medical excellence with the objective of providing best service to the patient. For over 25 years, the Institute has sought to find solutions to all ocular disorders through the expert application of innovative technology and techniques.
On-going training and research, participating actively in clinical trials, enable IMO to develop new therapeutic opportunities for the diagnostic and treatment of eye problems.
Its new premises, inaugurated in 2009 and boasting 70 consulting rooms and 8 operating theatres in an area of 22.000 square meters, have allowed IMO to become one of the biggest and most advanced centers in Europe. However, its hallmark is the medical team, led by 20 ophthalmologists sub-specialized in each part of the eye and the related pathologies. http://www.imo.es/en/ .
IRIS®II is a bionic vision system equipped with a bio-inspired camera and a 150 electrodes epi-retinal implant with a proprietary design intended to be explantable and eventually upgradable for patients who have lost sight due to Retinitis Pigmentosa (RP).
The Company received CE mark for IRIS®II at the end of July 2016, enabling Pixium to launch its commercial activities subject to reimbursement availabilities. CE mark approval for IRIS®II system enables the company to file for national reimbursements. The Company is working initially with public reimbursement authorities for innovative technologies for medical devices in France (under “Forfait Innovation”) and in Germany (with NUB).
About the Clinical study
The study referenced NCT02670980 (https://www.clinicaltrials.gov) evaluates performance and safety of IRIS®II in 10 patients suffering from retinitis pigmentosa, Usher Syndrome, Cone-Rod dystrophy, choroideremia will be included and followed for a minimum of 18 months, with additional 18 months follow-up, subject to patient consent.
The IRIS®II clinical trial, initiated in January 2016, is a multi-centric, open label, non-randomized prospective European study to assess effectiveness of the IRIS®II bionic vision system as treatment intended to compensate for blindness, by eventually providing a form of perception for blind persons and enabling them greater autonomy and quality of living. The trial is conducted in prestigious ophthalmology centers in France, the UK, Spain, Austria and Germany. http://www.pixium-vision.com/en/clinical-trial/participating-centers
About Pixium Vision
Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention as well as a rehabilitation period.
The company is developing two bionic retinal implant systems. IRIS®II, the company’s first bionic system, obtained CE mark in July 2016. In parallel, Pixium Vision has recently completed the pre-clinical study phases for PRIMA, a sub-retinal miniaturized wireless photovoltaic implant platform, and is planning to initiate first-in-human trials.
Pixium Vision collaborates closely with academic and research partners spanning across prestigious vision research institutions including the Institut de la Vision in Paris, the Hansen Experimental Physics Laboratory at Stanford University, and Moorfields Eye Hospital in London. The company is EN ISO 13485 certified.
For more information, please visit: www.pixium-vision.com;
Pixium Vision is listed on Euronext (Compartment C) in Paris
ISIN: FR0011950641; Mnemo: PIX
IRIS® is a trademark of Pixium-Vision SA
Pixium Vision shares are eligible for the French tax incentivized PEA-PME and FCPI investment vehicles.
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company’s Registration Document filed with the AMF under number R16-033 on April 28, 2016 which can be found on the websites of the AMF - AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS® is a trademark of Pixium-Vision SA