The Valencia, California-based company develops the system as a potential first-of-its-kind treatment for moderate-to-severe rheumatoid arthritis (RA). Its target population are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
SetPoint designed its rechargeable neurostimulation device to electrically stimulate the vagus nerve once daily. It activates the innate anti-inflammatory and immune-restorative pathways.
The company says it could potentially treat autoimmune conditions without the immunosuppressive risks associated with pharmacological therapies. After placement during an outpatient procedure, the system automatically delivers therapy on a preset schedule to improve compliance.
SetPoint Medical already has FDA breakthrough device designation for its system. Earlier this year, the FDA accepted the technology into its Total Product Life Cycle Advisory Program (TAP) pilot.
The company used data from its RESET-RA study to support the FDA PMA submission.
“We remain steadfast in our goal to address the unmet medical needs in RA treatment and look forward to continuing to work cooperatively with the FDA during the upcoming PMA review process,” said Alexis Dineen, VP of regulatory affairs for SetPoint Medical. “I am incredibly appreciative of all the SetPoint employees, RESET-RA study investigators and participants who have helped us get one step closer to offering this new treatment category to RA patients.”
