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NeoVista receives CE mark for wet AMD therapy system

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FREMONT, Calif. — NeoVista has received approval to apply the CE mark to its VIDION Anti-Neovascular Therapy System for treating wet age-related macular degeneration, the company announced in a press release.

VIDION, the company's epimacular brachytherapy device, is the first device of its kind to be approved for commercial sales, the release said.

The system targets beta radiation to leaking blood vessels that hamper central vision without damaging adjacent tissues. Targeted delivery of radiation, also known as epimacular brachytherapy, has yielded positive results in early clinical trials, the release said.

With CE marking status, NeoVista will be permitted to market the VIDION system in Austria, Hungary, Poland, Belgium, Iceland, Portugal, Bulgaria, Ireland, Romania, Cyprus, Italy, Slovakia, Czech Republic, Latvia, Slovenia, Denmark, Liechtenstein, Spain, Estonia, Lithuania, Sweden, Finland, Luxembourg, Switzerland, France, Malta, Turkey, Germany, the Netherlands, the United Kingdom, Greece and Norway.

"This is a momentous occasion for NeoVista as we look forward to bringing out technology to the EU with this first essential step towards commercialization," John N. Hendrick, NeoVista president and CEO, said in the release.