LONDON – Retina Implant AG, a developer of electronic sub-retinal implants for the visually impaired, has opened a manufacturing plant to meet anticipated demand for its devices.
The company has been revealing results from clinical trials in learned publications and plans to expand its second human clinical trial outside Germany in early 2011 to European countries including the U.K. and Italy. Discussions are underway for potential clinical trials in the United States and Asia.
The embedding of an artificial light-sensitive chip beneath the retina with connection to the optical nerve can be helpful where blindness is the result of retinitis pigmentosa, an inherited condition that leads to deterioration of the light sensitive cells in the retina.
The manufacturing plant meets standard for CE mark approval for the sub-retinal implant and the company is expected to apply for that in 2011. This would to allow the chip to be approved for use as a medical device throughout the European Union.
The core of the implant is a microchip of about 3-mm diameter and about 50-microns thickness, within which 1,500 light-sensitive pixels are arranged. This would correspond to an array of 50 x 30 pixels. Each pixel is 70 microns by 70 microns yielding a visual field of 12 degrees of arc, the company said.