NeoVista Receives CE Mark Approval To Distribute Wet AMD Device In Europe
Fremont, CA - NeoVista, Inc. announced that it recently received approval from BSI Product Services to apply the CE Marking to the company's focal epiretinal brachytherapy device, utilized in a new treatment for wet age-related macular degeneration (AMD). With CE Marking approval (also known unofficially as "CE Mark") NeoVista now has the ability to distribute and sell its product throughout all EU countries, offering a new treatment option for two million Europeans who are afflicted with wet AMD.
"This is a momentous occasion for NeoVista as a company as we look to expand our operations in the EU with this first essential step towards commercialization," said John N. Hendrick, President and CEO of NeoVista. "With this approval we hope to bring our treatment to millions of European patients with wet AMD who are seeking a more cost-efficient treatment option that will be potentially as effective as or better than the current standard of care."
The NeoVista technology delivers beta radiation (using strontium 90) for treatment of wet AMD. Similar in size and appearance to a fountain pen, the surgical device delivers focused beta radiation to leaking blood vessels that affect central vision, without causing damage to the surrounding tissues. As a result of its targeted delivery of radiation, preliminary data show that NeoVista's procedure can be safe for both the physician and the patient and may be able to restore some patients' vision.
The CE Mark is a mandatory European marking 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.
To market the therapy in the United States, NeoVista is currently in the midst of conducting its final Phase 3 clinical trial. The CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial is a multicenter, randomized, controlled study that is enrolling 450 patients at clinical centers worldwide. The objective of this study is to establish the safety and effectiveness of the focal epiretinal brachytherapy device in support of a future premarket application (PMA) for this device. Countries participating in the CABERNET trial outside of the United States include the United Kingdom, Austria, Spain, Germany, Switzerland, Israel, Brazil and Peru.
SOURCE: NeoVista, Inc.