FDA Grants Breakthrough Designation to PhotoPharmics for Non-Invasive Phototherapy Device in Parkinson’s Disease

SALT LAKE CITY--(BUSINESS WIRE)--PhotoPharmics, a pioneer in specialized phototherapy, today announced that it has received FDA Breakthrough device designation for the company’s non-invasive, in-home device for treating Parkinson’s Disease.

“Very few device companies receive Breakthrough designation. Our device is the first specialized phototherapy device ever to achieve this status,” said Kent Savage, CEO of PhotoPharmics. “We believe this is largely due to the improvements we saw in non-motor symptoms. Since there is no known cure for Parkinson’s disease, our mission is to help people recover function and return to what they enjoy doing most. This recognition by FDA validates our work.”

Per FDA, the Breakthrough Devices Program is for medical devices that provide for more effective treatment of life-threatening or irreversibly debilitating diseases. In order to receive Breakthrough designation, companies must demonstrate credible evidence that their technology addresses unmet need and offers potential improvements over current standard treatments.

According to the Parkinson’s Foundation, over one million Americans and ten million people worldwide suffer with Parkinson’s disease. With nearly 60,000 Americans are newly diagnosed each year, a number which is expected to double within the next 20 years.

PhotoPharmics is currently raising a B round to finance their pivotal, phase 3 study of this new technology and intends to begin recruiting in August 2020. Inquiries about this upcoming trial are welcomed at www.photopharmics.com.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms in seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective non-invasive treatments. Investor inquiries are welcomed. Learn more at www.photopharmics.com.

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