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Oraya's IRay earns Europe's CE mark of approval

Oraya Therapeutics earns approval in Europe for its stereotactic radiotherapy system designed to treat eye diseases, but IRay remains limited to investigational use in the U.S.

Oraya Therapeutics

For three years, Oraya Therapeutics out of California has been developing and fine-tuning a stereotactic device to treat diseases of the eye.

They call it the IRay system, by which researchers deliver low-energy X-rays to treat wet age-related macular degeneration (AMD), which--as the leading cause of vision loss in people older than 50--afflicts some 25 million to 30 million people worldwide, according to AMD Alliance International.

This week, the IRay has been granted the CE mark, certifying that the IRay system conforms to European Union safety, health, and environmental requirements.

"The CE mark requirements for an early stage medical device company are exceptionally challenging, particularly for a system as sophisticated and unique as the IRay," says Oraya CEO and President Jim Taylor.

The system uses what Oraya calls an I-Guide interface to hold the eye still while detecting eye motion, as well as a safety gating system that automatically shuts down the device should the patient move enough to cause misalignment.

Its radiation level is described as similar to that of a dental X-ray and comes with standard shielding to protect both patient and physician. In fact, the whole procedure involves only a topical anesthetic and is set up to work in an ophthalmology office setting. According to the company:

Evidence suggests that ionizing radiation can close inflammation mediated capillaries and further stop the inflammatory process in conditions such as choroidal neovascularization. Therefore, first clinical indication under study for the IRay system is treatment of wet AMD, in conjunction with the current "gold standard", anti-vascular endothelial growth factor (anti-VEGF) therapy.

The IRay is in clinical trials in Europe, with no immediate market release announced. An earlier study of 60 patients showed improved vision and reduced drug regimens, and another study of 150 patients in 10 locations is now under way.

The IRay remains limited to investigational use in the U.S.