Valencia, California–based SetPoint plans to initiate a multicenter, randomized, double-blind, sham-controlled pilot study in 2025. The plan is to enroll 60 people across the United States.
“We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area,” Dr. David Chernoff, SetPoint Medical’s chief medical officer, said in a news release. “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. The miniaturized stimulation device goes on the vagus nerve and is placed through a small incision on the left side of the neck in an outpatient procedure. Once a day, the device’s programming electrically stimulates the vagus nerve to activate innate anti-inflammatory and immune-restorative pathways.
In March, the FDA granted SetPoint Medical’s system a Breakthrough Device Designation and accepted the company into its Total Product Life Cycle Advisory Program (TAP) pilot.
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).
In addition, the SetPoint Medical system has breakthrough designation for treating rheumatoid arthritis (RA). The company says recent topline results from its RESET-RA clinical study demonstrated the system’s potential. According to SetPoint, the study showed the system could provide a safe and effective treatment alternative for people with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs.
