Oraya Therapeutics' IRay stereotactic radiotherapy system granted European CE Mark approval

Oraya Therapeutics, Inc. announces today that a leading European notified body has granted approval to designate the CE mark to Oraya's IRay^TM stereotactic radiotherapy system. Under development since 2007, the IRay is designed specifically to treat diseases of the eye, and the technology enables precise delivery of low energy X-rays for the treatment of wet age-related macular degeneration (AMD).

“Combination therapies as adjuncts to anti-VEGF therapy are showing great promise, and the growing body of data from radiation therapy studies during the last few years suggest that patient outcomes, treatment burdens and costs could all be positively impacted.”

Clinical trials for the IRay are now underway in Europe, in the first-ever masked and sham-controlled study intended to demonstrate the efficacy and safety of radiation therapy for the treatment of AMD. The one time radiation treatment is given in conjunction with the current standard of care anti-VEGF drug regimen, and with the expectation that visual acuity outcomes for the treated patients will be maintained with significantly less frequent drug injections as compared to the sham controlled group. 150 patients from up to ten sites will participate in the trial with approximately one third of those subjects receiving a sham exposure and the remainder receiving a radiation dose of either 16 or 24 Gray (GY).

In an earlier study of the device, over 60 patients were treated and subsequently monitored with the earliest patients now approaching 18 months since treatment. Presented results from that study have shown the potential for meaningful visual outcome improvements as well as a substantive reduction in the required drug regimen. Peter Kaiser, M.D., of the Cole Eye Institute at the Cleveland Clinic and a recognized expert on AMD has noted that "Combination therapies as adjuncts to anti-VEGF therapy are showing great promise, and the growing body of data from radiation therapy studies during the last few years suggest that patient outcomes, treatment burdens and costs could all be positively impacted." Dr. Kaiser participated in the design of Oraya's European clinical protocol, and remains an active advisor to the company.

Commenting on the recently granted CE mark, Jim Taylor, President & CEO of Oraya says "Obtaining the CE mark is another important achievement for the organization and for our investors. 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. Our success in that regard speaks highly of the maturity and discipline of the organization, as well as of the diligence taken in the design and development processes." Commenting further, Taylor noted that, "In conjunction with the strong progress in the ongoing sham-controlled clinical study, this regulatory clearance paves the way for Oraya's commercialization of this innovative and proprietary technology. We look forward to the potential to make a positive impact in the lives of AMD patients globally, while also offering a more cost effective alternative for the management and treatment of this debilitating disease."