Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), has announced that its wireless subretinal implant technology, the Alpha IMS, has received CE Mark.
Retina Implant’s technology, which has been in clinical trials across the world since 2005, is designed to restore useful vision in patients blinded by the degenerative eye condition retinitis pigmentosa (RP). To date, 36 patients have received the Alpha IMS microchip. This is the first European regulatory certification for the Company and the Alpha IMS device.
“We are delighted that our subretinal implant has received CE marking, validating the safety and potential benefits of our revolutionary product to patients and physicians,” said Walter-G Wrobel, Ph.D, CEO of Retina Implant AG. “We look forward to working with clinicians across Europe interested in offering their patients a new pathway to regain vision. We also want to thank all of the patients who participated in our clinical trials, as without their contributions, this day would not be possible.”
The Alpha IMS is a subretinal microchip consisting of a 3x3 mm2 microchip with 1,500 electrodes, more electrodes than any other device being used in humans, implanted beneath the retina, specifically in the macular region. Earlier this year, results from the Company’s second human clinical trial were published in Proceedings of the Royal Society B, finding that patients with the Alpha IMS chip were able to recognize faces and read signs on doors. Similarly, results from the Company’s first human clinical trial published in Proceedings of the Royal Society B in 2010 showed that placement of the implant beneath the fovea provided optimum visual results, allowing patients to recognize objects and facial expressions as well as read words and see dots on a pair of dice.
Coordinating investigator and founding director of the Institute for Ophthalmic Research at the Centre for Ophthalmology of the University of Tuebingen, Professor Eberhart Zrenner, added: “After more than seven years of rigorous testing in 36 patients, we are pleased to have demonstrated the safety, reliability and tolerability of the Alpha IMS. It was a very rewarding and touching experience to see blind patients regain some vision that helped them to better master the activities of daily life. This is a landmark in our journey to address the needs of the RP patient community which has limited treatment options available.”
Commenting on the CE marking, David Head, CEO of RP Fighting Blindness, said: “This is an important milestone and we congratulate Retina Implant AG. The latest results from the multi-centre clinical trial have shown the impact that Retina Implant’s technology has made in enhancing the quality of life for people living with RP. It is important to note that currently these devices offer hope to RP patients who are now completely blind, they are not suitable for partially-sighted people.”