PhotoPharmics Submits FDA Application for Parkinson’s Disease Therapy
510K De Novo Pathway Key to Market Authorization for Company’s Innovative Medical Device
July 16, 2018, Salt Lake City, UT— PhotoPharmics announced today that its De Novo request to the FDA has been accepted for review of the company’s Spectramax™ specialized phototherapy medical device for treating Parkinson’s disease.
“This is an exciting milestone in our company’s history,” said Dan Adams, Science Officer for PhotoPharmics. “We met with the FDA earlier this year to discuss the results of our pivotal clinical trial which paved the way for our submission. This is the culmination of several years of planning, regulatory and quality system execution, clinical trial design and management, data collection and statistical analysis.”
“It is exciting to be at this stage as a company,” said Kent Savage, CEO of PhotoPharmics. “We have accomplished a great deal with the support of some of the most capable movement disorder, regulatory, quality, legal, and statistical teams in the country. Our positive clinical data combined with the non-risk nature of our device means we’re optimistic about market authorization in the coming months.”
The De Novo pathway is available to organizations that can show low to moderate risk for their medical device, and where no predicate device has been cleared by the FDA. If approved, Spectramax specific bandwidth phototherapy could be the first treatment for Parkinson’s disease which offers symptomatic relief without significant side effects.
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 for 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 treatments. Learn more at www.photopharmics.com.