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NeoVista Inc. received approval from BSI Product Services to apply the CE mark to its anti-neovascular (ANV) therapy system (Vidion) to treat wet age-related macular degeneration (AMD), the company announced.
Fremont, CA—NeoVista Inc. received approval from BSI Product Services to apply the CE mark to its anti-neovascular (ANV) therapy system (Vidion) to treat wet age-related macular degeneration (AMD), the company announced.
The epimacular brachytherapy device is said to be the first of its kind to receive commercial approval, according to a statement issued by the company, and it has significant implications for neovascular AMD treatment. The CE mark provides NeoVista with the ability to sell the device in all European Union (EU) countries.
“This is a momentous occasion for NeoVista as we look forward to bringing our technology to the EU with this first essential step towards commercialization,” said John N. Hendrick, president and chief executive officer, NeoVista.
“With this approval, we will begin working with our distributor network to make available our technology to the multitude of European patients currently suffering from wet AMD who are seeking an effective therapeutic option that can potentially offer a better quality of life to the patient and decrease the current burden of treatment,” Hendrick added.
The ANV therapy system delivers targeted beta radiation to leaking blood vessels, which affect central vision, without causing damage to the surrounding tissues, according to the company. This targeted epimacular brachytherapy has shown promising clinical results in preliminary clinical trials, the company said.