Recruitment for Non-Invasive Parkinson’s Pivotal Study Slated for December

Recruitment for Non-Invasive Parkinson’s Pivotal Study Slated for December

Non-invasive Parkinson’s therapeutic device moves one step closer to FDA clearance, with important potential non-motor and motor improvements for patients.

The maker of the widely anticipated Celeste® specialized phototherapy device, PhotoPharmics, today announced plans to begin recruitment for the Celeste Light for PD trial in December.

“Multiple forces have aligned to make the timing for our pivotal clinical study here and now,” said Kent Savage, PhotoPharmics CEO. “We have leveraged this time to work with FDA, gather input from our clinical advisory board, and coordinate with the trial team at the University of Rochester Medical Center. Once we finalize related funding details, recruitment will begin in earnest.”

Savage added, “Fortunately, demand for non-pharmaceutical and non-invasive solutions like Celeste from people with Parkinson’s and their care partners has only increased. We have heard from thousands of people patiently waiting for the opportunity to experience the benefits of Celeste.”

The Celeste device delivers specialized wavelengths and intensities of light that target the activation of the melanopsin receptors in the eye. These photoreceptors are critical to the circadian pathway that is damaged in Parkinson’s disease.

This pivotal, or phase 3 trial, builds on an earlier company-sponsored positive proof-of-concept clinical study which led to FDA Breakthrough device designation.

Ray Dorsey, MD, lead investigator for the Celeste trial and professor of neurology at the University of Rochester Medical Center, earlier said, “A stay-at-home trial featuring a non-invasive device is perfect for our time. Anyone with Parkinson’s from across the country will be able to apply, even those in remote locations as long as they have an internet connection.”

“Celeste has great promise, given the clinical results to date, its simple non-invasive approach, and its ability to be used along with all available PD therapies,” said Dr. Karl Kieburtz, chief medical officer at PhotoPharmics. “For most people with Parkinson’s, no current therapies fully resolve their symptoms and quality of life continues to deteriorate.

“We are eagerly working with the trial team at CHeT to finalize trial preparations and begin recruitment,” Savage said. “Validating the therapeutic benefits and safety of Celeste through a trial of this magnitude is our company’s highest priority.”

About CHeT

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The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester Medical Center. Their team designs and conducts multi-center clinical trials with collaborators from across the globe to accelerate clinical research and advance the development of therapeutics, benefiting individuals in our community and beyond. Since its inception over three decades ago, CHeT has reshaped the conduct of clinical trials, from incorporating novel technologies into clinical trial design to modeling disease progression. Learn more at https://www.urmc.rochester.edu/health-technology.aspx.

About PhotoPharmics

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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).

The PhotoPharmics Clinical and Scientific Advisory Board (CSAB) is chaired by C. Warren Olanow, MD, and draws on the expertise of world leaders in Parkinson’s disease including Ray Chaudhuri, MD, Rajesh Pahwa, MD, Joohi Jimenez-Shahed, MD, Dan Claassen, MD, MS, and Amy Amara, MD, PhD. Details at https://photopharmics.com/advisory-board/.

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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“Breaking Through the FDA” (Biosphere, 2021)

Innovative medical devices and diagnostics can get to patients and providers sooner under the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Program. The program provides a special regulatory Breakthrough Device Designation for medical products that have the potential to more effectively treat or diagnose serious or life-threatening conditions. See the full article on page 19 >

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

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

Breakthrough device innovator will leverage the expertise of leading authorities to bolster the company’s future success in treating major unmet needs of Parkinson’s disease and beyond

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.”

The board will be chaired by C. Warren Olanow, MD, a leading researcher, clinician, and influencer in developing solutions for PD and other neurodegenerative diseases, advisor to dozens of life science companies and organizations, including the Michael J Fox Foundation and National Space Board Research Institute, and the recipient of a lifetime achievement award from the International Parkinson and Movement Disorder Society.

“We are extremely pleased that Dr. Olanow has agreed to chair our Advisory Board,” said Kent Savage, CEO of PhotoPharmics. “Add to his impressive background the expertise of each of our other experts, and we are well organized to move our breakthrough platform technology through trials and into the hands of people with Parkinson’s and other neurodegenerative diseases.”

Joining Dr. Olanow on this board will be:

  • Ray Chaudhuri, MD, a world leading authority on non-motor symptoms of Parkinson’s disease, professor of neurology/movement disorders at King’s College London, author of hundreds of papers in this field, and co-editor of five books on PD.
  • Rajesh Pahwa, MD, Chief of the Parkinson’s and Movement Disorder Division and Director of Parkinson Foundation Center of Excellence at the University of Kansas Medical Center, author of more than 200 peer-reviewed articles, and instrumental in over 100 clinical trials related to PD and other movement disorders.
  • Joohi Jimenez-Shahed, MD, Medical Director of Movement Disorders Neuromodulation at Mount Sinai Hospital, principal investigator for several related clinical trials, widely published, and an emerging expert in intraoperative neurophysiology for patients undergoing deep brain stimulation (DBS) and the application of wearables and digital health technologies in PD.
  • Dan Claassen, MD, MS, Chief of Behavioral and Cognitive Neurology at Vanderbilt University, specializes in the diagnosis and treatment of neurodegenerative disorders characterized by disruptions to cognition, behavior, and movement—particularly in PD, Huntington’s, and atypical PD.
  • Amy Amara, MD, PhD, leads research efforts around movement disorders neurology and sleep at the University of Alabama at Birmingham, specializes in studies sleep disorders in PD, the influence of non-pharmacologic interventions such as exercise on sleep disorders, cognition, and other non-motor symptoms, with deep research in biomarkers in PD and interventions to improve safety in patients.

“As an emerging leader in non-invasive specialized light therapy for neurodegenerative diseases, PhotoPharmics will benefit from the advice and insight of this world-class advisory board,” said Karl Kieburtz, MD, Chief Medical Officer of PhotoPharmics. “The board will be extraordinarily valuable as we continue our clinical investigations and prepare to commercialize our therapeutic solutions.”

The board will meet regularly to advise on key strategic decisions, review emerging research, and support the company’s scientific, clinical and commercialization efforts.

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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PhotoPharmics Appoints Dr. Karl Kieburtz as Chief Medical Officer

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PhotoPharmics Appoints Dr. Karl Kieburtz as Chief Medical Officer

World-renowned neurologist and movement disorders specialist joins PhotoPharmics as company advances breakthrough device through pivotal clinical trial and to commercialization

August 31, 2021, Salt Lake City, UT—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.

Dr. Kieburtz has extensive experience executing clinical trials for Parkinson’s disease programs across all stages of development. Dr. Kieburtz is currently President of Clintrex Research Corporation, a leading clinical research organization that facilitates the clinical and regulatory aspects of drug and device development for biotech and pharma organizations. Dr Kieburtz’s role as CMO is part of an on-going collaboration between PhotoPharmics and Clintrex. He also continues as Professor of Neurology at the University of Rochester, where he was founding director of the Center for Health & Technology (CHeT).

“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.”

“I am excited to join PhotoPharmics, an emerging leader in non-invasive light therapy for neurodegenerative diseases,” said Dr. Kieburtz. “PhotoPharmics and Clintrex have been collaborating for several years on a developing a clinical and regulatory strategy for a therapeutic light to treat the motor and non-motor features of Parkinson’s disease. I am pleased to move to the next phase of clinical development with PhotoPharmics, taking on the role of CMO and helping to guide the company through a final pivotal study and towards commercialization. The product has great promise, given the results to date, its simple non-invasive approach, and its ability to be used along with all available PD therapies.”

In addition to his work at the University of Rochester and Clintrex Research Corporation, Dr. Kieburtz was the initial Robert J. Joynt Professor in Neurology and served as the Senior Associate Dean for Clinical Research and Director of the Clinical & Translational Science Institute in Rochester. His primary research interest is novel therapeutics for neurodegenerative diseases. He led the NINDS sponsored trials of neuroprotective agents for PD (NET-PD), served as the Chair of the Executive Committee of the Parkinson Study Group, and directed the Clinical Core for the Fox Foundation sponsored Parkinson Progression Marker Initiative. He previously served on and chaired the FDA Advisory Committee on Peripheral and Central Nervous System Disorders. In 2009, he was one of the co-founders of Clintrex Research Corporation which has collaborated with over 150 organizations in developing products for brain and neurological disorders. Dr. Kieburtz received his BA in Neuroscience from Amherst College and completed his MD and MPH degrees at the University of Rochester as well as his neurology training and Fellowship in experimental therapeutics.

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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Utah-based PhotoPharmics Selected as Global Top 50 Startup

Utah-based PhotoPharmics Selected as Global Top 50 Startup

MedTech Innovations designates PhotoPharmics as one of the industry’s best and brightest startups working to transform patient care through innovation

June 24, 2021. Salt Lake City—PhotoPharmics today announced it has been selected by MedTech Innovator as a top 50 medtech startup and will be showcased in MedTech’s 2021 cohort featuring the industry’s most transformative device, diagnostic, and digital health technologies.

“We’re delighted with this designation and honor,” said Kent Savage, CEO of PhotoPharmics. “International attention from leading organizations like MedTech brings us closer to delivering on our mission of innovation, particularly providing a breakthrough, non-invasive treatment for people suffering from the symptoms of Parkinson’s disease.”

“We’re seeing a real breakthrough here,” said Savage. “Once approved, this may be the first therapy to address non-motor problems in Parkinson’s, one that we feel promises a nearly 5-year reversal of symptom progression—based on the results of our last clinical trial.”

PhotoPharmics will participate in MedTech’s flagship four-month Showcase and will receive unparalleled visibility and access to leading manufacturers, providers, investors, and other industry stakeholders. The program culminates at The MedTech Conference, powered by AdvaMed, on September 27-30, where all 50 companies will present in Showcase panels and gain access to exclusive partnering and roundtables.

The selection process for this year’s program was extremely competitive, with only a 4% acceptance rate. Together with the senior leadership teams of its corporate partners and over 200 industry judges, MedTech Innovator evaluated 1,100 candidates from 54 countries and 42 U.S. states.

“Our goal at MedTech Innovator is to find the most promising medical innovations and make sure they actually reach the patients who need them,” said Paul Grand, CEO of MedTech Innovator. “We are thrilled with the caliber of the startups participating in this year’s cohort and we look forward to providing them with the resources and mentorship they need to succeed.”

In the company’s short history, PhotoPharmics boasts a series of major accomplishments, including:

  • Completing a phase 2 trial in Parkinson’s, which is the first to show significant improvements in non-motor symptoms, quality of life, and sleep—all on top of best medical care (non-motor symptoms are the most urgent unmet need in Parkinson’s disease)
  • Receiving FDA Breakthrough Device designation in early 2020 for the company’s non-invasive phototherapy device in Parkinson’s disease
  • Preparing a phase 3 pivotal trial and announcing the largest phototherapy trial for improving overall function in Parkinson’s disease

“We look forward to the additional resources being offered as part of this distinction,” said Savage. “Partnering with MedTech and AdvaMed at this level promises great results for our company.”

About MedTech Innovator
Based in Los Angeles, Calif., MedTech Innovator is the largest accelerator of medical device companies in the world and the premier nonprofit startup accelerator in the medical technology industry. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the health care system. MedTech Innovator matches health care industry leaders with innovative early stage and emerging-growth medtech companies for mentorship and support.

MedTech Innovator’s founding sponsors are Johnson & Johnson and RCT Ventures. Annual program sponsors include NIPRO Medical Corp., Olympus Medical Systems Group, Asahi Intecc, Baxter, Becton Dickinson & Company, Edwards Lifesciences LLC, Dexcom, Fujikura Ltd., Jabil Healthcare, Maxim Integrated Ventures, W. L. Gore & Associates, Inc., Experien Group, Greenlight Guru, Integrated Computer Solutions (ICS), Medmarc, Medical Technology Enterprise Consortium (MTEC), Oliver Healthcare Packaging, Proxima Clinical Research, Silicon Valley Bank, Three Bridges Management & Consulting, Westwood & Wilshire, and Ximedica. The organization’s industry partners include AdvaMed, Health+Commerce, MedTech Strategist, and Wilson Sonsini Goodrich & Rosati.

For more information about MedTech Innovator, visit https://medtechinnovator.org/.

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 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.

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