SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot.
TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week.
With acceptance into TAP, SetPoint can progress the development of its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS).
SetPoint designed its device to use precise vagus nerve stimulation. It activates anti-inflammatory and immune-restorative pathways to treat inflammation-mediated autoimmune conditions.
The SetPoint platform features a miniaturized stimulation device placed on the vagus nerve. Once placed through a small incision on the left side of the neck in an outpatient procedure, the device automatically delivers therapy on a preset schedule.
It also has breakthrough designation for the treatment of rheumatoid arthritis (RA). The company continues evaluating the investigational platform in a pivotal clinical trial for the treatment of RA as well.
“We’re excited to be included in the TAP Pilot as the program will help streamline collaboration with the FDA – from initiating the first-of-its-kind clinical trial evaluating this approach for people living with RRMS, to accelerating access to this breakthrough therapy upon approval,” said Alexis Dineen, VP of Regulatory rffairs at SetPoint Medical. “Ultimately, this program highlights the FDA’s commitment to spur development and widespread access of safe and effective treatment options to the people that need them most.”