First IRay Radiotherapy System Will Ship from US to Europe

Oraya Therapeutics Inc. and OnCore Manufacturing LLC officials announce that production of the first commercial unit in the United States of the IRay Radiotherapy System for the treatment of wet age-related macular degeneration (AMD), the leading cause of permanent vision loss in the industrialized world. IRay, the medical device at the core of Oraya Therapy, is CE marked and is currently available in the United Kingdom and Switzerland. The first commercial production comes as Oraya and OnCore have signed a long-term contract to facilitate Oraya’s continued expansion in Europe.

The IRay was developed to offer a non-invasive approach for treating wet AMD and to reduce the number of anti-vascular endothelial growth (anti-VEGF) injections into the eye that are the current standard of care. Typically, patients are monitored monthly and may require five to seven injections per year to maintain vision. Oraya Therapy is the only therapy option on the market today that has demonstrated the ability to reduce anti-VEGF injections while maintaining or improving vision.

“There is a critical need for new treatments for wet AMD, particularly those that can reduce the burden of anti-VEGF injections. The cost of monthly injections along with the high volume of patients requiring treatment place a strain on health care systems and providers, and are exceptionally difficult for patients and caregivers,” states Oraya President and CEO Jim Taylor. “We anticipate that Oraya will rapidly ramp up production in the coming months as more clinics offer the therapy and patient awareness grows.”

Oraya holds 44 patents associated with the IRay system, which consists of a low energy X-ray source that produces a highly collimated narrow beam designed to affect only the target area or lesion, with minimal scatter onto surrounding healthy tissue. A self-contained automated beam positioning system ensures the precise entry of energy into the eye, avoiding critical structures such as the lens and optic nerve. Specialized software ensures accurate treatment planning and precise beam positioning. A proprietary eye stabilization device, working with the beam positioning system, enables precise localization and tracking of the eye.

Key to the successful production of the IRay was Oraya’s decision early in the commercialization process to partner with OnCore, enabling the company to focus on technology development, while leveraging OnCore’s manufacturing and supply chain expertise at its Fremont, Calif., facility. Oraya, like a growing number of medical device and high technology companies, was looking to capitalize on the close proximity of its manufacturing partner to create an integrated IRay team that was able to reduce time-to-market.

“The medical device industry is looking for partners with exceptional engineering, supply-chain and manufacturing expertise, which they can leverage to accelerate their product commercialization process. Many are finding this expertise is here domestically,” says OnCore President and CEO Sajjad Malik. “We worked hand-in-hand with Oraya to manufacture the IRay, and we’re prepared to continue this close partnership as Oraya expands into new geographic markets.”

“Our close proximity and partnership with the team at OnCore’s Medical Center of Excellence manufacturing facility has allowed both companies to be very involved in the development and manufacture of the IRay, which has offered flexibility and most importantly, ensures our product is of the highest quality,” Taylor adds.

The IRay is not available for sale in the USA. For more information, please visit www.orayainc.com.

Source: Oraya Therapeutics Inc.