PhotoPharmics recently said it received FDA breakthrough device designation for noninvasive Specialized Phototherapy Device to treat Parkinson’s disease.
The device is administered through a prescription from a doctor and is an adjunct therapy for treating Parkinson’s disease, according to the company. It is designed to be used with standard dopaminergic therapy and can be used at home.
“Very few device companies receive the breakthrough designation. Our device is the first specialized phototherapy device ever to achieve this status,” CEO Kent Savage said in a news release. “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.”
The company is currently financing a pivotal, phase 3 study of the device through a Series B round and plans to recruit for the study starting in August this year.
