The FDA approved its SetPoint neuroimmune modulation system for treating rheumatoid arthritis (RA) last month. The first-of-its-kind device treats adults with moderate-to-severe RA not adequately managed by (or failing to tolerate) existing therapies. Those therapies include biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
Valencia, California-based SetPoint Medical designed the implantable, integrated neurostimulation system to deliver electrical stimulation to the vagus nerve once per day. It activates the body’s innate anti-inflammatory and immune-restorative pathways to treat RA.
Doctors performed the first implantation on Aug. 22 at Northwell’s North Shore University Hospital in Manhasset, New York. The patient will receive follow-up care in the coming weeks, at which time the device will be activated.
According to a news release, the collaboration between the company and hospital leverages the SetPoint device to modulate immune responses and alleviate painful RA symptoms without immune-compromising risks. Northwell already participated in the company’s RESET-RA study used to support its FDA PMA submission last fall.
“Northwell Health is committed to providing patients with the most scientifically-backed, innovative and effective treatment options available,” said Michael J. Dowling, president and CEO of Northwell. “Our collaboration with SetPoint Medical reinforces this commitment by offering a groundbreaking new approach for managing rheumatoid arthritis, a condition that significantly impacts millions of lives.”
SetPoint Medical said it expects to introduce the SetPoint system in certain U.S. cities through a targeted launch this year. It anticipates a wider launch across the country in early 2026.
