NeoVista, Inc.
NeoVista's novel device takes first step towards commercialization in European market.
Fremont, CA, August 4, 2009 -- NeoVista, Inc. today announced that it recently received approval from BSI Product Services to apply the CE Marking to it's VIDION® Anti-Neovascular (ANV®) Therapy System to treat wet age related macular degeneration (AMD). VIDION is the company's epimacular brachytherapy device, the first of its kind to receive commercial approval, which has the potential to change the landscape of neovascular AMD treatment. With CE Marking approval (also known unofficially as "CE Mark") NeoVista now has the ability to sell VIDION in all EU countries, offering a new treatment option for millions of Europeans afflicted with wet AMD.
"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 CEO of 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."
NeoVista technology delivers ionizing beta radiation (using strontium 90) to the choroidal neovascularization (CNV) due to wet AMD. The VIDION ANV Therapy System is designed to deliver targeted beta radiation to leaking blood vessels that affect central vision, without causing damage to the surrounding tissues. This targeted delivery of radiation, also referred to as epimacular brachytherapy, has shown promising clinical results in preliminary clinical trials.
The CE Mark is a mandatory European directive for certain product groups (e.g. medical devices) to indicate conformity with the essential health and safety requirements outlined in the European Medical Device Directive (legislation passed by the EU). NeoVista received their CE Mark after demonstrating, through audits by BSI, conformance to the Directive and to the internationally recognized quality management system standard for medical devices, ISO 13485:2003.
Often considered the trade passport for non-EU products in the European marketplace, the CE Mark was adopted by the EU to establish a single-market approach and to promote economic development among the member states. After being granted permission to affix the CE Mark to the product by an EU-accredited Notified Body such as BSI, NeoVista will now be able to market the product in the following countries that require CE Marking: 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.
###
About NeoVista, Inc.
NeoVista, Inc. is a privately held development-stage medical device company based in Fremont, California. For more information about the company, or this novel wet AMD therapy, please visit the company's Web site at www.neovistainc.com.