“Very few device companies receive Breakthrough designation. Our device is the first specialized phototherapy device ever to achieve this status,” said Kent Savage, CEO of PhotoPharmics. “We believe this is largely due to the improvements we saw in non-motor symptoms. Since there is no known cure for Parkinson’s disease, our mission is to help people recover function and return to what they enjoy doing most. This recognition by FDA validates our work.”
Per FDA, the Breakthrough Devices Program is for medical devices that provide for more effective treatment of life-threatening or irreversibly debilitating diseases. In order to receive Breakthrough designation, companies must demonstrate credible evidence that their technology addresses unmet need and offers potential improvements over current standard treatments.
According to the Parkinson’s Foundation, over one million Americans and ten million people worldwide suffer with Parkinson’s disease. With nearly 60,000 Americans are newly diagnosed each year, a number which is expected to double within the next 20 years.
PhotoPharmics is currently raising a B round to finance their pivotal, phase 3 study of this new technology and intends to begin recruiting in August 2020. Inquiries about this upcoming trial are welcomed at www.photopharmics.com.