PARIS--(BUSINESS WIRE)--Regulatory News:
Pixium Vision (Paris:PIX), a company developing and commercializing innovative bionic vision systems with the intention to allow patients who have lost their sight to lead more independent lives, announces completion of 10 implants in its IRIS® II study. All implanted patients will now follow their re-education program as defined in the ongoing European multi-centric study for IRIS® II which was launched in January 2016.
Khalid Ishaque, CEO of Pixium, said: "The completion of enrollment demonstrates important interest in our innovative IRIS® II bionic vision system. Many in the ophthalmology and artificial vision community look forward to the interim updates which can be expected later in 2017 which will be important for Pixium Vision’s development of retinal implant systems. The company is dedicated to conceive, develop and bring meaningful bionic vision innovations to surgeons, which shall enable them to treat patients who have lost sight to retinal dystrophies.”
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
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 the 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.
Pixium Vision is listed on Euronext (Compartiment 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