Retina Implant AG’s Alpha IMS gets CE Mark

Reutlingen, Germany-Retina Implant AG, a developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), has received the CE Mark for its wireless subretinal implant technology (Alpha IMS).

The developer’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 RP. To date, 36 patients have received the microchip. This is the first European regulatory certification for the company and its 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, PhD, chief executive officer of Retina Implant AG. “We look forward to working with clinicians across Europe interested in offering their patients a new pathway to regain vision.”

The device is a subretinal microchip, consisting of a 3 × 3 mm² microchip with 1,500 electrodes implanted beneath the retina, specifically in the macular region.

“After more than 7 years of rigorous testing in 36 patients, we are pleased to have demonstrated the safety, reliability, and tolerability of the Alpha IMS,” added Prof. Eberhart Zrenner, coordinating investigator and founding director of the Institute for Ophthalmic Research at the Centre for Ophthalmology of the University of Tuebingen. “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.”

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