Santa Clarita – October 29, 2026 -- SetPoint Medical has treated its first patient in Boston with the SetPoint System, extending the only FDA-approved neuroimmune modulation therapy for rheumatoid arthritis (RA) to adults across New England.

Beth Israel Deaconess surgeon performs first Boston implant

Joshua P. Aronson, M.D., a functional neurosurgeon at Beth Israel Deaconess Medical Center (BIDMC), performed the procedure. He described it as an outpatient intervention that opens a different treatment pathway for RA patients.

The system includes a small implantable neurostimulator that delivers targeted stimulation to the left vagus nerve. The stimulation activates the body's innate anti-inflammatory pathways to regulate the immune activity associated with RA.

FDA label covers adults who failed biologic or targeted DMARDs

The approval covers adults with moderately to severely active RA who have had an inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). More than 1.5 million Americans live with RA, which has no cure. Many patients do not achieve or sustain adequate disease control on existing DMARD therapies.

BIDMC rheumatologist Brian J. Stout, M.D., said the therapy offers a different mechanism of action for patients not managed with initial biological agents, and that an alternative to immunosuppressives "expands the treatment options we have for managing RA."

SetPoint cites growing U.S. footprint, plans MS and Crohn's evaluation

SetPoint President and CEO Murthy V. Simhambhatla, Ph.D., said BIDMC's clinicians are expanding access for patients throughout New England. The company said Boston joins a growing list of U.S. markets where rheumatology practices, neurosurgeons and health systems are making the therapy available.

SetPoint also plans to evaluate its platform for other conditions, including multiple sclerosis and Crohn's disease.

Label excludes patients with vagotomy or splenectomy

The system should not be used by patients who have had a vagotomy or splenectomy, or whose healthcare provider deems it unsafe. Listed risks include post-surgical pain or infection, hoarseness, bruising, swelling, coughing and throat irritation.