First-of-its-kind study is intended to evaluate if neuroimmune modulation can promote remyelination in people with relapsing-remitting multiple sclerosis (RRMS)

IDE approval follows TAP Pilot acceptance and Breakthrough Device Designation for the treatment of RRMS

SetPoint Medical, a clinical-stage healthcare company dedicated to people living with chronic autoimmune diseases, today announced that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to study its proprietary neuroimmune modulation platform in people living with relapsing-remitting multiple sclerosis (RRMS).

The multicenter, randomized, double-blind, sham-controlled pilot study will be initiated in 2025 and will enroll up to 60 patients across the United States.

Affecting nearly one million people in the United States, multiple sclerosis (MS) is an autoimmune disorder that damages the myelin sheath, which is 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 root cause of MS – damage to the myelin sheath.

“We look forward to initiating this pilot study to advance SetPoint's platform in another therapeutic area,” said David Chernoff, M.D., 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.”

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 Breakthrough Device Designation and accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in March 2024 for the treatment of relapsing-remitting multiple sclerosis (RRMS).

Additionally, the company recently announced positive topline results from the landmark RESET-RA clinical study. The study data demonstrated the potential of the SetPoint System 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 (DMARDs).

About SetPoint Medical

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 is designed 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. For more information, visit www.setpointmedical.com.

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