Recent Press Releases
Innovation not only brings improved treatments to address large, unmet medical needs but can also improve access for underserved patient populations. PhotoPharmics today announced its intent to leverage its Breakthrough Device designation, CMS’s MCIT rule, and global delivery channels to deliver its treatments for Parkinson’s and neurodegenerative diseases to individuals regardless of their location or income.
The strength of the Company’s phase 2 data encouraged FDA to grant Breakthrough Device designation (details here) for its home-based, non-invasive therapeutic device in Parkinson’s. This designation speeds FDA’s review process for devices that provide for more effective treatment for life-threatening or irreversibly debilitating diseases.
July 14, 2020, Salt Lake City, UT— PhotoPharmics, a pioneer in specialized phototherapy for neurodegenerative diseases, today announced a collaboration with the Center for Health + Technology (CHeT) at the University of Rochester Medical Center to conduct an at home, telemedicine, phase 3 trial to establish safety and efficacy for the company’s non-invasive specialized phototherapy device for Parkinson’s disease.
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.”
February 10, 2020, Salt Lake City, UT— PhotoPharmics announced today plans to conduct a pivotal trial to assess the efficacy of Celeste®, the company’s specialized phototherapy device to improve overall function in Parkinson’s disease (PD). The Celeste device builds on the company’s innovative Spectramax™ technology that has been used in previous human research. The company anticipates enrolling approximately 200 people in what will likely be the largest trial of its kind, the final details of which are forthcoming.
Pivotal Parkinson’s Disease Clinical Trial Results Released at the International Movement Disorders Society Congress
October 5, 2018, Hong Kong, China—PhotoPharmics today released the results of its multinational, double blind, randomized controlled trial in Parkinson’s disease at the annual International Movement Disorders Society meeting in Hong Kong. The study is entitled “Double-blind controlled trial of Spectramax™ light therapy for the treatment of Parkinson’s disease patients on stable dopaminergic therapy.”
July 16, 2018, Salt Lake City, UT— PhotoPharmics announced today that its De Novo submission to the FDA has been accepted for review of the company’s Spectramax™ phototherapy medical device for treating Parkinson’s disease.
February 1, 2018, Salt Lake City, UT—PhotoPharmics completed a multinational double-blind, randomized clinical trial of its pivotal Spectramax™ medical device to demonstrate safety and efficacy of the company’s specific bandwidth phototherapy for overall improvement in Parkinson’s disease.