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news.NeoVista has received approval from the 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.
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With CE Marking approval 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 wet age-related macular degeneration (AMD).
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’s vision.
To market the therapy in the US, NeoVista is currently in the midst of conducting its final Phase III clinical trial. The Cabernet 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 for this device. Countries participating in the Cabernet trial outside of the US include the UK, Austria, Spain, Germany, Switzerland, Israel, Brazil and Peru.
John Hendrick, president and CEO of NeoVista, said: “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.”