SetPoint Medical Announces Filing of Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA) for Novel Neuroimmune Modulation Device for the Treatment of Rheumatoid Arthritis

PMA submission showcases company’s advancement in developing potential first-of-its-kind treatment option for patients with rheumatoid arthritis (RA)

VALENCIA, Calif.--(BUSINESS WIRE)--SetPoint Medical, a clinical-stage healthcare company dedicated to people living with chronic autoimmune diseases, today announced that it has filed its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SetPoint System, a potential first-of-its-kind neuroimmune modulation device 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).

“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, Vice President 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.”

The PMA submission is supported by positive 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 for RA patients who do not respond to or cannot tolerate the current standard of RA care.

The SetPoint System includes an implantable, rechargeable neurostimulation device designed to electrically stimulate the vagus nerve to activate innate anti-inflammatory pathways, providing the potential to treat autoimmune conditions like RA while preserving immune surveillance. After placement during an outpatient procedure, the SetPoint System is programmed to automatically stimulate the vagus nerve daily on a preset schedule to improve adherence and persistence with therapy.

The SetPoint System has Breakthrough Device Designation for treatment of adult RA patients who are incomplete responders or are intolerant to one or more biologic or targeted synthetic DMARDs. SetPoint’s neuroimmune modulation platform 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).

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 anti-inflammatory and 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.