SetPoint Medical Reports 1st Commercial Use of Neuromod for Rheumatoid Arthritis

SetPoint Medical announced that Northwell Health is the first health system to offer the recent U.S. Food and Drug Administration (FDA)-approved SetPoint system, a bioelectric medicine treatment for rheumatoid arthritis (RA).

The FDA approved the SetPoint System on July 30, providing a non-pharmaceutical treatment option for adults with moderate-to-severe RA who aren’t adequately managed by—or can’t tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

The SetPoint system is an implantable, integrated neurostimulation device that delivers electrical stimulation to the vagus nerve once a day to activate innate anti-inflammatory and immune-restorative pathways. The company believes the therapy could transform RA care by providing a treatment option without immune-compromising risks.

The first patient to receive the device underwent the implantation on August 22 at Northwell’s North Shore University Hospital. The patient will get follow-up care in the coming weeks, during which time the device will be activated.

Northwell participated in the RESET-RA study, which assessed the efficacy and safety of the SetPoint System, and showed the potential of this therapy to provide relief.

“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.”

Earlier this month, SetPoint raised $140 million in private financing to support commercialization of the SetPoint system. The company plans to expand its launch across the country in 2026.