All Press Releases

PhotoPharmics Announces First Subject Completes FDA Pivotal Clinical Trial for the Celeste Device in Parkinson’s

PhotoPharmics, a leader in non-invasive phototherapy for neurological disorders, has reached a significant milestone in its ongoing FDA pivotal “Light for PD” trial for the Celeste therapeutic device. The first subject has successfully completed the full 6-month treatment course and clinical visits, marking an important step towards the successful completion of the trial and future FDA authorization of Celeste in treating Parkinson’s disease (PD).

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PhotoPharmics Welcomes Three Renowned Experts to Its Clinical & Scientific Advisory Board

PhotoPharmics, an innovator in light-based therapies for neurodegenerative diseases, proudly announces the appointment of three eminent experts to its Clinical & Scientific Advisory Board (CSAB). The new members—Dr. Charles H. Adler, Dr. George Brainard, and Dr. Robert A. Hauser—bring unparalleled expertise to the advisory board, reinforcing PhotoPharmics’ mission to pioneer groundbreaking treatments for Parkinson’s disease and other neurodegenerative disorders.

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PhotoPharmics Enrolls First 100 Participants in Groundbreaking Parkinson’s Disease Trial

PhotoPharmics, a leader in neurodegenerative disease phototherapy, today announced the enrollment of the first 100 subjects in its Light for PD clinical trial. This marks a significant milestone in evaluating Celeste, the company’s FDA Breakthrough light therapy device for Parkinson’s disease (PD). Organizers are on track to enroll 300 subjects—interested individuals with PD may find details at lightforpd.com.

The Light for PD trial is a randomized, double-blind, placebo-controlled study that aims to demonstrate safety and significant improvement in motor and non-motor symptoms beyond current medical care in PD.  Parkinson’s disease happens when the brain can no longer regulate essential signaling for movement and other function. Recent discoveries implicate the eyes as part of this signaling process. Celeste passively delivers specific wavelengths of light aimed to restore retinal signaling, improving function and quality of life for those living with PD.

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PhotoPharmics Enrolls First 25 Patients in Pivotal Parkinson’s Disease Study to Improve Symptoms Beyond the Current Standard of Care

PhotoPharmics, the leader in specialized phototherapy for neurodegenerative diseases, today announced the successful enrollment of its first 25 patients into the Celeste Light for PD Trial. This groundbreaking trial represents a significant advancement in Parkinson’s disease (PD) treatment, where motor treatments become less effective over time, and no FDA approved treatments exist for many debilitating non-motor symptoms.

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Largest Phototherapy Trial for Parkinson’s Disease

PhotoPharmics, a pioneer in specialized phototherapy for neurodegenerative diseases, alongside the Center for Health + Technology (CHeT) at the University of Rochester Medical Center (URMC), today announced the initiation of a groundbreaking pivotal trial. The “Celeste Light for PD Trial” (found at lightforpd.com) represents a significant stride in Parkinson’s disease (PD) treatment, leveraging innovative Spectramax™ technology through the passive and non-invasive Celeste® phototherapy device.

This pivotal trial will assess the efficacy of Celeste®, the company’s FDA Breakthrough phototherapy device to improve non-motor and motor function and quality of life in Parkinson’s disease (PD). The Celeste device builds on the company’s innovative Spectramax™ technology that has been successfully used in previous human research. This 300-patient phototherapy trial will be the largest trial of its kind.

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Celeste® Light for PD Trial to be Presented at World Parkinson’s Congress

PhotoPharmics, a leading innovator in Parkinson’s disease, today announced that it will be presenting its pivotal trial design at the World Parkinson Congress July 5th to 7th, 2023 in Barcelona. Aimed at advancing the company’s FDA breakthrough therapy (https://photopharmics.com/fda-grants-breakthrough-designation-for-non-invasive-phototherapy-device-in-parkinsons-disease/) one step closer to market, this at-home, remote randomized clinical trial further solidifies PhotoPharmics’ position as a pioneer in treating Parkinson’s disease.

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PhotoPharmics to Present at MTI All Stars Investor Showcase

PhotoPharmics today announced CEO Kent Savage has been invited to present at the inaugural MTI All Stars Investor Showcase at Device Talks Boston on May 10 and 11. The event will feature pitches from 22 MedTech Innovator alumni companies, offering essential insights for investors, engineers, executives, and other medical device industry professionals.

According to event organizers, DeviceTalks Boston is designed to provide valuable insights in easy-to-identify tracks, for funding and leading start-ups, engineering and developing new prototypes and devices, manufacturing medical devices with new materials and technologies, and bringing new products to market through regulatory, reimbursement, and commercial challenges.

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PhotoPharmics brings renowned experts in Parkinson’s disease and other neurodegenerative diseases to advisory board

Clinical-stage medical device maker PhotoPharmics today announced a Clinical & Scientific Advisory board (CSAB) comprised of six leading experts in Parkinson’s disease (PD) and other neurodegenerative diseases. The board’s aim is to provide clinical and scientific advice and direction to support the PhotoPharmics mission to “Improve the lives of people who suffer from neurodegenerative diseases.”

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PhotoPharmics Appoints Dr. Karl Kieburtz as Chief Medical Officer

PhotoPharmics announced today that it has appointed Karl Kieburtz, MD, MPH, as Chief Medical Officer (CMO). In his role as CMO, Dr. Kieburtz will oversee the company’s clinical strategy and activities, including direct supervision of scientific development, clinical operations, data science, and interactions with FDA.

“We are delighted to welcome Dr. Kieburtz to lead our clinical development,” said Kent Savage, President & CEO of PhotoPharmics. “He has an extensive track record in Parkinson’s disease and is a proven leader in central nervous system disorders. His insight and expertise will be invaluable to PhotoPharmics as we advance development of our therapies in Parkinson’s disease and other neurodegenerative diseases.”

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PhotoPharmics Innovations Address Global Health Inequalities

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.

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Phase 3 Trial Aims to Establish Non-Motor Improvement in Parkinson’s

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.

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FDA Grants Breakthrough Designation for Non-Invasive Phototherapy Device in 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.”

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Largest Phototherapy Trial for Parkinson’s Disease

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.

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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.”

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Media Contact

Brett Walker
801.770.6960
brett.walker@photopharmics.com