SetPoint® System Used for First Time in Pacific Northwest to Treat Patients with Rheumatoid Arthritis in Clinical Practice

Access to the first and only FDA-approved neuroimmune modulation therapy for rheumatoid arthritis continues to grow across the United States

VALENCIA, Calif. , Sept. 16, 2026 /PRNewswire/ -- SetPoint Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that Oregon Health & Science University (OHSU) is the first health system in the Pacific Northwest to treat a patient with the SetPoint System. The treatment is the first and only U.S. Food and Drug Administration (FDA)-approved neuroimmune modulation therapy for adults living with moderately to severely active rheumatoid arthritis (RA).

"At OHSU, we are committed to bringing innovative, evidence-based therapies to patients with complex conditions like rheumatoid arthritis," said Ahmed M. Raslan, M.D., FAANS, chair of Neurological Surgery at the School of Medicine at OHSU in Portland, Oregon. "The clinical development of the SetPoint System demonstrates how advances in neuromodulation can extend beyond traditional neurological disorders to address immune-mediated diseases. Our multi-disciplinary approach enables us to offer RA patients across Pacific Northwest access to innovative technologies proven to improve clinical outcomes and quality of life."

Rheumatoid arthritis is a chronic autoimmune condition in which the immune system attacks the tissue lining the joints, resulting in pain, swelling, stiffness and, over time, irreversible joint damage. An estimated 1.5 million adults in the United States are living with RA. Despite advances in pharmaceutical treatment options over the past two decades, many patients continue to have inadequately controlled disease or cannot tolerate existing therapies, underscoring the need for additional treatment options.

The SetPoint System addresses this need as the first-and-only U.S. Food and Drug Administration (FDA)-approved neuroimmune modulation device for people living with RA who experience inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). It includes a small, implantable neurostimulator that delivers targeted stimulation to the left vagus nerve, activating the body's innate anti-inflammatory pathways that help regulate the immune activity associated with RA. Patients charge the device at home using a wireless charger that is worn around the neck for a few minutes each week.

"OHSU has a longstanding reputation for clinical excellence and innovation," said Murthy Simhambhatla, Ph.D., CEO of SetPoint Medical. "We are grateful to collaborate with one of the nation's leading academic medical centers to expand access to neuroimmune modulation for RA patients in Oregon and the Pacific Northwest."

With this milestone, Oregon joins the growing list of U.S. markets where patients can access SetPoint Therapy, as the company continues to build relationships with medical centers and rheumatology practices nationwide.

About the SetPoint System
The SetPoint^® System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs. It should not be used if you have had a vagotomy or splenectomy, or if your healthcare provider determines that it is not safe for you to use the SetPoint System. Risks may include, but are not limited to, pain or infection after surgery, hoarseness, bruising, swelling, coughing and throat irritation.

For full safety information, please see Instructions for Use and our Important Safety Information at spm.care/ISI.

Individual results may vary.

About SetPoint Medical
SetPoint^® Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases. The company's FDA-approved SetPoint System is the first neuroimmune modulation therapy available for people living with rheumatoid arthritis, offering a novel, device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. SetPoint's proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. With a vision to redefine the care of autoimmune conditions, SetPoint is also planning to evaluate its platform technology for other conditions including multiple sclerosis and Crohn's disease. Learn more at www.setpointmedical.com.

SOURCE SetPoint Medical