PhotoPharmics has announced its intent to leverage its FDA breakthrough device designation, potential streamlined Medicare coverage under CMS’ pending Medicare Coverage of Innovative Technology (MCIT) rule and global delivery channels to deliver its treatments for Parkinson’s and neurodegenerative diseases to individuals regardless of their location or income. Innovation not only brings improved treatments to address large, unmet medical needs but can also improve access for underserved patient populations.
Commenting on this effort, PhotoPharmics CEO, Kent Savage said, “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 of people suffering from neurodegenerative diseases.”
“We commend PhotoPharmics for taking on this challenge to ensure that their innovative treatment is accessible to all who need it, including underrepresented patient populations, said Kelvyn Cullimore, president and CEO of BioUtah.
“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 strength of the Company’s phase 2 data encouraged FDA to grant breakthrough device designation 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.
“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/.