SetPoint Medical’s Neuromod Device for Multiple Sclerosis Added to FDA TAP Pilot

SetPoint Medical revealed it’s been accepted into the U.S. Food and Drug Administration (FDA)’s Total Product Life Cycle (TPLC) Advisory Program (TAP) to develop its novel neuroimmune modulation platform for relapse-remitting multiple sclerosis (RRMS).
 
This news follows SetPoint’s announcement last week that the FDA awarded the company Breakthrough Device Designation for its device to treat RRMS. The evidence the breakthrough nod was based on showed the device could both reduce demyelination and promote remyelination, according to the company.
 
The integrated neurostim device leverages vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions. It’s placed in an outpatient procedure then programmed to automatically stimulate the vagus nerve once daily to activate the inflammatory reflex and achieve a systemic immune-restorative effect.
 
The FDA’s Center for Devices and Radiological Health (CDRH) released the TAP Pilot with the aim of providing access to safe, effective, high-quality medical devices upon FDA approval. The agency broadened the program to neurological and physical medicine devices in October 2023.
 
The TAP Pilot allows SetPoint to 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, SetPoint Medical’s VP of regulatory affairs. “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.”

In addition to strategic advice from the FDA, SetPoint will also have earlier and more frequent communication with providers, payors, and patients.