SetPoint Medical Wins FDA Approval for Neuroimmune Modulation Platform Study

The U.S. Food and Drug Administration (FDA) has granted SetPoint Medical Investigational Device Exemption (IDE) approval to study its proprietary neuroimmune modulation platform in patients with relapsing-remitting multiple sclerosis (RRMS).
 
The multicenter, randomized, double-blind, sham-controlled pilot study will begin next year and enroll up to 60 U.S. patients.
 
Affecting nearly 1 million U.S. residents, multiple sclerosis (MS) is an autoimmune disorder that damages the myelin sheath—the protective layer that surrounds and insulates nerve fibers. This disrupts signals to and from the brain, causing neurodegeneration and a cascade of debilitating symptoms such as visual impairment, difficulty walking, sensory disturbance, pain, cognitive difficulty, and fatigue. There is currently no cure for MS, and while the currently approved medicines can help slow down disease progression and, in some instances, ease some of the symptoms, there are no approved treatments that work on reversing the disease’s root cause—damage to the myelin sheath.
 
“We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area,” SetPoint Medical Chief Medical Officer David Chernoff, M.D., said. “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.”
 
The SetPoint System includes an implantable, rechargeable neurostimulation device that electrically stimulates the vagus nerve once daily to activate innate anti-inflammatory and immune-restorative pathways. After placement during an outpatient procedure, the SetPoint System is programmed to deliver scheduled therapy once daily. The device was also granted FDA Breakthrough Device Designation and accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in March 2024 for treating RRMS.
 
The company also has shared positive results from the landmark RESET-RA clinical study. The trial demonstrated the SetPoint System’s potential to provide a safe and effective treatment alternative to the current standard of care for adults living with moderate-to-severe rheumatoid arthritis (RA) who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs.
 
SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating people living with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate neuroimmune pathways to produce a systemic immune-restorative effect. SetPoint Medical’s platform technology aims to offer patients and providers a treatment alternative for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy.