IRIS®II, recognized as an innovative device responds to the first eligibility condition for the package of innovation
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Pixium Vision will complete its application for funding of derogation with the clinical data, the most recent available
Paris, may 24, 2017 – 7 :30 CET – Pixium Vision (FR0011950641 – PIX), a company that develops vision systems bionics innovative to enable patients with vision loss to live more independently, announces that the documents submitted to the High Authority of Health (HAS) in the framework of the funding request override (package innovation) of his system of vision bionic IRIS®II must be completed to obtain a notice of eligibility in favour.
The assessment by the HAS recognizes the innovative IRIS®II in support of retinitis pigmentosa, a medical need not sufficiently covered. IRIS®II meets the first eligibility condition for the package innovation. The HAS request that the file be completed of clinical data, the most recent. It also recommends that the clinical study proposed as part of the application package innovation to be adapted in order to assess the impact of IRIS®II on criteria of quality of life.
Pixium Vision intends to share with the HAS all of the latest clinical data available from IRIS® in retinitis pigmentosa. In the first place, Pixium Vision will provide the updated data presented at the recent congress of the French Society of Ophthalmology, which show the effectiveness perennial IRIS® and its positive impact on the quality of life of patients. The clinical outcomes of IRIS®II after six months of rehabilitation in 10 patients implanted will also be integrated into the final assessment, as soon as they are available. Finally, the protocol of the clinical study will be re-evaluated based on the recommendations of the HAS.
Khalid Ishaque, ceo of Pixium Vision, said : “We welcome with satisfaction the decision of the HAS to recognize IRIS®II, our first system, vision bionics, developed in France and cleared for marketing in the European Union, as a medical device innovation that helps to improve the quality of life of patients with retinitis pigmentosa. Clinical studies are ongoing and the results of effectiveness and tolerance in patients implanted with IRIS is favorable. They will feed, in the same way as the reflection on the protocol of the clinical study recommended, the constructive dialogue that we conduct with the HAS in order to conclude the eligibility of our system IRIS®II package innovation”.
Company’s innovative, French-single by the parallel development of two systems of vision bionics, Pixium Vision is committed to a constructive approach with the regulatory authorities to ensure that patients with Retinitis Pigmentosa can benefit in the best conditions of its vision system bionic IRIS®II, and answer a medical need in poorly covered.
ABOUT PIXIUM VISION
The mission of Pixium Vision is to create a world of vision bionics to allow those who have lost the order to recover some of their visual perception and to gain autonomy. Vision systems, bionic Pixium Vision are associated with a surgery and a rehabilitation period.
The company develops two vision systems, and bionics. IRIS®II, the first system has obtained the CE mark in July 2016. In parallel, Pixium Vision has recently finalized phases of preclinical studies of PRIMA, an implant photovoltaic subretinal miniaturized and wireless, and plans to start the first clinical trials in Humans.
Pixium Vision is working in close collaboration with academic partners of world renown such as the Vision Institute in Paris and the Laboratory of experimental physics Hansen at Stanford University and Moorfields Eye Hospital in London. The company is certified IN ISO 13485.
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