Azernews.Az

By Bloomberg

Pixium Vision SA has enough test patients for its Iris retina-implant technology to start seeking European product-safety approval as early as this month in a bid to enter the growing market for alleviating blindness.

Pixium wants by June to receive the CE mark verifying that Iris is safe enough to be sold in the 28-country European Union and some nearby markets, Chairman Bernard Gilly said in an interview. The company will work to double the number of patients using the implants to 10 by March from five currently, generating enough device-effectiveness data by late 2015 to encourage health authorities to permit reimbursement.

“Our retinal implant will bring a significant difference to the patient,” Gilly said at Pixium headquarters in Paris. “There’s room for two players, probably three, in this market, as is the case for cochlear implants.”

One U.S. medical-equipment manufacturer and two in Europe have already persuaded health insurers to pay for devices that restore some vision to people suffering from blindness. While only patients with the degenerative disease retinitis pigmentosa are currently eligible to use the technology, research and trials could lead to a first treatment option for more of the world’s 39 million blind.

Closely held Retina Implant AG, based in Reutlingen, Germany, has qualified for reimbursement from that country’s state-regulated health-insurance system for its Alpha IMS microchip. U.S. competitor Second Sight Medical Products Inc. secured French government funding this year to implant 36 patients with its Argus II prosthesis after obtaining reimbursement rights in Germany, Italy and the U.S.

Stock Performance

Second Sight has surged 56 percent since the Sylmar, California-based manufacturer raised $32 million in an initial public offering in the U.S. last month. By contrast, Pixium has dropped 17 percent on the Euronext exchange since the company raised 34.5 million euros ($43 million) in an IPO in June.

Gilly said he expects Pixium’s stock to rally when test results are published next year showing that the French device is as eligible for the same range of insurance coverage as Second Sight. France’s health-care payment system and German insurers pay about 100,000 euros apiece for the Argus II.

Pixium’s technology, which provides patients with enough sight to let them avoid objects while walking around includes a camera that requires less energy than the Second Sight product, an implant with more electrodes, enabling better resolution, and software that the user can adjust, Gilly said. The company is also working on a version that would increase vision enough for patients to read and recognize faces.