Retina Implant AG, a leading developer of subretinal implants for the visually impaired, today announced the opening of a new manufacturing plant to meet anticipated demand for their implants. The company's second human clinical trial will be expanding outside of Germany in early 2011 to European countries including the U.K. and Italy and discussions are underway for potential clinical trials in the United States and Asia. Also looking ahead, the new facility meets manufacturing capabilities required for CE mark approval.
“Today marks an exciting milestone in Retina Implant's journey to restore vision to the blind”
The new manufacturing plant is 312 m², more than 25 times larger than the former plant, and is located in Technology Park, Tübingen-Reutlingen, Germany. Of this space, 100 m² is dedicated as a clean room, with the capability to increase its size to 250 m². A clean room denotes an atmosphere with low particle numbers to guarantee foreign biological substances will not contaminate product. Manufacturing capacity is estimated to be 1500 units per year. Retina Implant AG is planning to invest another 1.3 Mio.EUR to stock the facility with specialized equipment to produce their state-of-the-art retinal implants. Four trained employees will begin working in the plant with the capacity to grow to 15 employees.
"Today marks an exciting milestone in Retina Implant's journey to restore vision to the blind," said Walter-G. Wrobel, CEO of Retina Implant AG. "Pending positive results of the second human clinical trial currently underway, our new manufacturing facility will position us well to make our implants available quickly to patients in need. We're encouraged by the first few implanted patients in our second clinical trial, specifically with how they have been able to function in their home without assistance."
Retina Implant AG is hosting a grand opening today, October 12, 2010 at 9:00 a.m. Central European Summer Time. Speakers include Retina Implant CEO Walter-G. Wrobel, Professor Eberhart Zrenner, M.D., director and chairman of the Institute for Ophthalmic Research at the Center for Ophthalmology of the University of Tüebingen, Germany, Professor Hugo Hämmerle, director of the Natural and Medical Sciences Institute, as well as Lord Mayor Barbara Bosch.
Positive clinical results from the first clinical trial found implanted patients can recognize objects and read at a basic level by moving only their eyes and have been presented at a number of scientific meetings including the Eye and Chip Annual Meeting held in September 2010 in Detroit, Mich. as well as the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held in May 2010 in Fort Lauderdale, Fla.
Retina Implant AG is scheduled to present the findings at the upcoming American Academy of Ophthalmology Annual Meeting in Chicago, Ill. on October 16.
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