Oraya Therapeutics of Newark, CA, has received the European CE Mark for its IRay stereotactic radiotherapy system.
Under development since 2007, IRay is designed to deliver low-energy x-rays for the treatment of wet age-related macular degeneration. Clinical trials for IRay are now under way in Europe.
According to the company, in an earlier study of the device, more than 60 patients were treated and subsequently monitored, with the first patients now approaching 18 months since treatment. Presented results have shown the potential for meaningful visual outcome improvements and a reduction in the required drug regimen.
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