Grußwort vom Chairman
The mission of Pixium Vision is to restore sight to those who have lost it. Blindness is a major unmet medical need in the world: approximately 285 million people with visual impairment were enumerated in 2010, of whom 40 to 45 million were completely blind. For these patients, there is no curative treatment to date
Pixium Vision addresses this important medical and social need by developing two innovative Bionic Vision Systems (BVS), IRIS® and PRIMA. These systems aim to provide blind patients a form of bionic vision as close to normal as possible.
Each BVS comprises three elements: a retinal implant that stimulates nerve cells, a visual interface, in the form of a pair of glasses that includes a mini-camera for capturing images, and a pocket computer that converts the visual information into electrical signal transmitted wirelessly to the implant to stimulate the retinal cells and thus create a "visual perception". BVS are associated with surgery and a rehabilitation program.
Pixium Vision intends to commercialize its BVSs by first targeting Retinitis Pigmentosa (RP) and, secondly, Age-related Macular Degeneration (AMD) in its dry form, a disease for which there is no effective treatment. These irreversible pathologies affect people who had normal vision until the onset of symptoms. Each year, 15,000 to 20,000 new RP patients lose their sight in the United States and in Europe. Age-related Macular Degeneration also affects many more people in Europe and the United States: 350,000 to 400,000 new patients lose their eyesight each year. Ageing population drives the rapid growth of AMD worldwide
IRIS®II, a system designed to be explantable with 150 electrodes, has been granted CE Mark since July 2016 which allows it to be marketed in the European Union. Procedures to obtain reimbursement were initiated with a first successful step in Germany in early 2017. In France, negotiations are underway with the health authorities to obtain the “Forfait Innovation”, which should allow more patients to benefit from this innovative treatment. In addition, since June 2013, clinical trials on IRIS® are being conducted in several ophthalmological centres of excellence in Europe. To date, the implant is well tolerated by patients and improvements in visual perception are observed. The results of these studies will complement demands for ongoing reimbursements.
PRIMA, a miniaturized wireless sub-retinal photovoltaic implant, has completed its pre-clinical development, demonstrating its safety in several in-vivo and ex-vivo models. The company works closely with regulatory authorities in Europe and the United States to prepare for the first-in-human implantations of this breakthrough technology. We plan to start clinical trials of PRIMA in Europe in 2017.
The funds raised during our IPO enabled Pixium Vision to deploy its strategy and demonstrate our ability to sustain the clinical development of IRIS®II until its commercial launch in Europe and to fund the first steps for the clinical development of the PRIMA system.
Pixium Vision, with its two bionic vision systems IRIS®II and PRIMA and their breakthrough technologies, is in a unique position to significantly contribute to the restoration of a form of artificial vision to people who have lost sight, in order to enable them to live more autonomously, develop their life plans and improve their integration into society.
Bernard Gilly, Chairman co-founder of Pixium Vision