“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/.