The approved bionic eye

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The Second Sight Argus(R) II epiretinal prosthesis is officially supported by the Ministry of Social Affairs and Health: 36 blind patients with retinitis pigmentosa will be able to benefit from the Argus II "bionic eye" from September 2014.

Second Sight Medical Products Inc. (Second Sight) announced today that the French Ministry of Social Affairs and Health has published the order of August 4, 2014 relating to the coverage under Article L. 165-1-1 of the Social Security Code of the Argus II epiretinal prosthesis system. This treatment is provided as part of the Innovation Package and will concern a first cohort of 36 patients, with little or no vision, suffering from retinitis pigmentosa (RP).

The announcement that the French Ministry of Health will take charge of this procedure, which restores part of the visual function in visually impaired patients, follows the decision of March 18, 2014 to make Argus II benefit from the Innovation Package. The Innovation Package is a specific program that accelerates the availability of innovative technologies for patients.

Three hospitals will take part in the programme from 1 September: the CHNO des Quinze-Vingts in Paris (Dr. Pierre-Olivier Barale and Dr. Saddek Mohand-Saïd), the University Hospital of Strasbourg (Prof. Hélène Dollfus and Prof. David Gaucher) and the University Hospital of Bordeaux (Prof. Jean-François Korobelnik and Prof. Marie-Noëlle Delyfer).

Second Sight's Argus II system received CE marking in Europe in 2011 and US FDA approval in 2013. It is the first epiretinal prosthesis to obtain these approvals worldwide. The Argus II has already been implanted in more than 90 patients. Many of these patients have been living with the prosthesis for more than seven years, demonstrating the long-term reliability of the device. The company has published 20 articles in peer-reviewed journals, including the most recent in BMC Ophthalmology: "The Argus II prosthesis facilitates reaching and grasping tasks: a case series" by Kotecha et al in BMC Ophthalmology 2014, 14:71.

Using a miniature camera housed in the patient's eyeglasses, the Argus II converts captured video images into a series of electrical pulses that are transmitted wirelessly to a bundle of electrodes placed on the surface of the retina. These pulses then stimulate retinal cells, resulting in the brain's perception of light patterns. The patient then learns to interpret these light patterns while regaining visual abilities.

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"We have standardized the care pathway for retinitis pigmentosa with a system that is tailor-made for these patients who are blind or partially sighted, says Grégoire Cosendai, Vice-President of Second Sight Europe. "More and more countries are offering the Argus II in Europe and we are pleased to be able to implement the routine procedure in France. »

"We are thrilled that the Ministry of Health has officially announced funding for Argus II and that CHNO in the U.S. will continue to offer this revolutionary treatment to our patients".The two doctors, Dr. Mohand-Saïd and Dr. Barale, from the CHNO des Quinze-Vingts in Paris. "In 2008, we were the first team in France to be able to implant four patients with the Argus II retinal prosthesis system as part of the clinical trial, and to appreciate the benefits for these people who previously had no choice but to accept living in complete darkness. By restoring some visual function in blind people with retinitis pigmentosa, Argus II offers great hope by improving mobility and interaction with others, thus reducing the isolation that blind people often suffer from. Patients are in great demand and we look forward to offering them this treatment in the near future. »

"As a geneticist and ophthalmologist, I can tell you that retinopathy pigmentosa is a very difficult genetic disease, which robs patients of their sight little by little, often from childhood."adds Prof. Dollfus (MD, PhD); Centre de Référence Maladies Rares CARGO (Affections Rares en Génétique Ophtalmique), Hôpitaux Universitaires de Strasbourg. "In addition to having to deal with the loss of their own sight, patients fear that their descendants may also carry the disease and be condemned to lose their sight in turn. Therapeutic developments for rare diseases often represent a very long journey and we are particularly pleased to see that we can help our patients in this way. »

"Thanks to Argus II, we can finally give some of our patients good news and offer them a safe therapeutic approach that is designed to evolve and restore a certain degree of functional vision".explains Prof. Gaucher, head of surgical and medical retinal pathologies, ophthalmology department of Strasbourg University Hospital, and associate researcher at the bacteriology laboratory, University of Strasbourg. "We are delighted to offer this treatment at Strasbourg University Hospital. »

"The recent announcement by the Ministry of Health of the Argus II treatment means that retinal prostheses are now moving from the stage of investigation and hope to that of a concrete medical reality", adds Prof. Korobelnik, Head of the Ophthalmology Department of Bordeaux University Hospital. "Ophthalmologists in France will be among the first in the world to be able to offer prostheses in clinics to patients suffering from this serious disease, retinitis pigmentosa. We hope that their independence will be increased and improved and that they will regain a better quality of life. I am very pleased that Bordeaux University Hospital is one of the three centers of excellence selected to offer Argus II treatment to patients suffering from retinitis pigmentosa. I hope that in a second phase, other centres will be opened. »

About Retinitis Pigmentosa (RP)

RP is a serious hereditary disease that causes progressive degeneration of light-sensitive cells in the retina. It leads to major visual impairment and blindness. It is estimated that 1.2 million people worldwide suffer from it. Second Sight's Argus II system uses electrical stimulation to bypass dead cells and to stimulate the remaining viable cells to induce visual perception in blind people. The Argus II is the first artificial retina to receive CE marking in Europe and FDA approval in the United States.

About the Argus (R) II system

The Argus II system is the second generation of Second Sight retinal prostheses, which follows the Argus I system introduced in 2002. The system is approved in Europe and the United States and has been given to more than 90 patients worldwide. The system is reimbursed in Germany, Italy and the United States; and is available in 16 centres of excellence in Europe.

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About Second Sight
Second Sight Medical Products, Inc. based in Los Angeles, California, was founded in 1998 to create a retinal prosthesis to restore vision in blind patients with peripheral retinal degeneration, such as retinitis pigmentosa. Through dedication and innovation, Second Sight's goal is to develop, manufacture and market implantable vision prostheses to enable blind people to achieve greater independence. The company's U.S. headquarters are based in Sylmar, California, and the European headquarters are based in Lausanne, Switzerland.
For more information : www.2-sight.com

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