SetPoint Medical has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration to study its neuroimmune modulation platform in patients with relapsing-remitting multiple sclerosis (RRMS).
 
The SetPoint system features an implantable, rechargeable neurostimulator that electrically stimulates the vagus nerve once daily to activate innate anti-inflammatory and immune-restorative pathways. After placement in an outpatient procedure, it’s programmed to deliver scheduled therapy once a day.
 
The system was granted breakthrough status and accepted in to the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in March 2024 to treat RRMS.
 
The company also recently released positive topline results from its landmark RESET-RA study. The study data showed the SetPoint system’s potential provide a safe, effective treatment alternative to the current standard of care for adults living with moderate-to-severe rheumatoid arthritis (RA) who are incomplete responders or intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
 
“We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area,” said David Chernoff, MD, chief medical officer of SetPoint Medical. “The results from our studies in validated preclinical models of MS suggest that the SetPoint System has the potential to address the urgent unmet medical need for novel therapies that reduce demyelination and promote remyelination—providing new hope for people living with MS.”