Retina Implant opens new manufacturing plant in Germany
Plans 2011 launch of sub-retinal implant technology for the visually impaired
Retina Implant, a developer of sub-retinal implants for partially sighted and blind patients, has opened a new manufacturing plant in Tubingen-Reutlingen, Germany with a dedicated cleanroom.
The company's second human clinical trial will be expanding from Germany in early 2011 to European countries including the UK and Italy. Discussions are also underway for potential clinical trials in the US and Asia. Also looking ahead, the new facility meets manufacturing capabilities required for CE mark approval.
The new 312m manufacturing plant includes 100m dedicated as a cleanroom, with the capability to increase this to 250m. Manufacturing capacity is estimated to be 1,500 units per year.
Retina Implant is planning to invest another €1.3m to stock the facility with specialised equipment to produce the retinal implants. Four employees will initially work at the plant, but this is expected to increase to 15.
“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,” said Walter-G Wrobel, ceo of Retina Implant.
“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.”
Positive clinical results from the first clinical trial found implanted patients could recognise objects and read at a basic level by moving only their eyes.