Utah-based Life Sciences Company to Combine Breakthrough Designation and MCIT to Provide At-home Access for the Treatment of Neurodegenerative Diseases
AMERICAN FORK, UTAH, US, April 12, 2021 /EINPresswire.com/ — 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.
CMS’s pending Medical Coverage of Innovative Technology (MCIT) rule will grant immediate coverage to Breakthrough devices, thereby providing early access to new treatments. The rule is currently open to public comment. PhotoPharmics has joined industry organizations AdvaMed and MDMA to urge immediate passage of the bi-partisan supported rule.
“With approximately 90 percent of people with Parkinson’s already covered by Medicare, this coordination between FDA and CMS will remove approval and payment barriers and allow expedited access to those who suffer most – regardless of their income,” said Kent Savage, CEO of PhotoPharmics.
“The third and final piece of the treatment and care puzzle is to reach patients in remote locations,” said Savage. “Some estimate that as high as 35 percent of those covered by Medicare live in remote locations and have far less access to quality care. Reaching and serving these patients in their home has always been our priority. Our therapeutic device will fit naturally into this rapidly expanding system of care—from remote physician prescriptions to drop-shipping methods that make reaching patients anywhere more possible than ever before.”
PhotoPharmics is validating in-home delivery, treatment, care, and symptom assessment in its upcoming phase 3 clinical trial. People with Parkinson’s will be recruited electronically and enrolled via Zoom. The Company’s breakthrough therapeutic device will be drop-shipped to patients’ homes across the U.S. Then, medical staff will assure proper set up, use of the device, and symptom assessment via telehealth.
The Company’s phase 3 pivotal trial is expected to begin as early as summer 2021. Patients and their care partners can view details or sign up to be notified at https://photopharmics.com/patient-experience/.
“The future is bright,” said Savage. “Innovations like these will expedite delivery of new standards of care for our most vulnerable, underserved populations. We are proud to play a role in improving the lives a people suffering from neurodegenerative diseases.”
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.