Oraya Therapeutics - 2014 Fierce 15

CEO: Jim Taylor
Based: Newark, CA
Founded: 2007
Website: www.orayainc.com

The scoop: Oraya's novel device for treating wet age-related macular degeneration (the leading cause of blindness in the developed world) reduces the number of injections needed to treat the condition. The company's low-voltage X-ray device safely delivers radiation to the back of the eye. The 20-minute, noninvasive surgery is available at eye care centers in the United Kingdom, Germany and Switzerland. In August, CEO Jim Taylor said 100 patients have obtained it commercially.

What makes Oraya Therapeutics Fierce: Prior to the advent of Oraya's technology and the associated surgery (carried out by independent doctors), "the ability to deliver a targeted dose of radiation to the precise point in the eye was seemingly insurmountable," Taylor told FierceMedicalDevices in an interview, noting that the macula, located in the back of the eye, is a small (4 millimeters) and moving target. He said Oraya overcame the technical and scientific challenges through advanced robotics, a laser-guided positioning system and a patented methodology for eye stabilization and tracking.

Regular (and expensive) injections of anti-VEGF (vascular endothelial growth factor) have been proven effective in clinical trials, but "in the real world having patients maintain that level of monitoring and therapy just does not happen," Taylor said. Most patients need about 8 injections per year to maintain their vision, Taylor said.

But patients in the INTREPID clinical trial with fluid in the retina and a lesion size of 4 millimeters or less who used Oraya's treatment experienced a mean 45% reduction in injections over the subsequent two years, and nearly a quarter needed no additional injections; a broader cohort including patients not as well suited experienced a mean reduction of 25%.

The company has received the support of investors and the science community. It pulled off a $42 million Series C round in 2009 and this August received a National Institutes of Health grant to study applications of its novel radiation therapy against cancer when used in conjunction with gold nanoparticles.

What to look for: Taylor said that due to tighter reimbursement of anti-VEGF injections abroad, as well as the FDA's high regulatory hurdles, Oraya is focusing on the European market, where the cost of anti-VEGF injections is €1,000 to €2,000, adding that the X-ray therapy is priced so that it pays off in savings from reduced injections in about half a year.

In July, Oraya announced that a hospital in the United Kingdom and four others in Germany are offering the 20-minute noninvasive surgery, joining a hospital in Switzerland that has offered the therapy since 2013. And more "centers of excellence" will offer it soon, Taylor said, predicting a doubling or tripling of the outlets by the end of the year.

Improved drugs like Ophthotech's clinical-stage candidate Fovista could threaten Oraya's position in the medium to long term. Taylor said he is monitoring them, but not worried, because they do not address the problems of cost and convenience that are inhibiting anti-VEGF therapy commercially. Eye care drugs often perform worse in "the real world" than in clinical trials because of the compliance challenges, Taylor said. In any case Oraya's therapy is complementary to the new medications, since it reduces, rather than eliminates, their use.

The NIH believes Oraya's targeted radiation delivery system could have applications in the treatment of eye cancers like retinoblastoma and choroidal melanoma. The grant researchers hope to demonstrate that high concentrations of gold nanoparticles can be targeted to endothelial cells in the eye without damaging the surrounding tissue, so that X-ray beams from Oraya's device can strike the nanoparticles, causing them to release electrons over a short distance that will damage diseased cells.

The primary focus remains Europe, but Asia and the U.S. are targets too. Taylor said Oraya is in early conversations with the FDA and anticipates strong demand for wet AMD treatments in the country due to the aging of the baby boomers. -- Varun Saxena (email | Twitter)

For more:
Oraya receives NIH grant to study use of its novel eye radiation tech against cancer
Device to combat wet AMD spreads in Europe, spurs NIH interest

Oraya Therapeutics - 2014 Fierce 15