FDA Grants Breakthrough Designation for Non-Invasive Phototherapy Device in Parkinson’s Disease
PhotoPharmics achieves priority designation for innovative PD therapy
April 29, 2020, Salt Lake City, UT— PhotoPharmics, a pioneer in specialized phototherapy, today announced that it has received FDA Breakthrough device designation for the company’s non-invasive Specialized Phototherapy Device. This prescription device is intended as an adjunct therapy for the treatment of Parkinson’s disease. It is intended to be used concurrently with standard dopaminergic therapy and is designed primarily for home use.
“Very few device companies receive Breakthrough designation. Our device is the first specialized phototherapy device to achieve this status,” said Kent Savage, CEO of PhotoPharmics. “Our focus is to help people with Parkinson’s improve function and return to what they enjoy doing most. We think this recognition by FDA validates our work.”
The Breakthrough Devices Program is intended to deliver more timely access to 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, a number which is expected to double within the next 20 years. Nearly 60,000 Americans are newly diagnosed each year.
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.
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.