First Patient in Minnesota Treated with SetPoint System for Rheumatoid Arthritis
Milestone expands patient access to FDA-approved neuroimmune modulation therapy across Rochester and Minneapolis–Saint Paul metropolitan areas.
VALENCIA, Calif. – September 01, 2026 – SetPoint® Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that the first patient in Minnesota has been treated with the SetPoint® System, marking an important milestone in the expansion of access to neuroimmune modulation therapy for rheumatoid arthritis (RA).
The SetPoint System is the first-and-only U.S. Food and Drug Administration (FDA)-approved neuroimmune modulation device for adults living 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).
“Rheumatoid arthritis care has advanced enormously, and yet many patients remain inadequately controlled on available therapies or simply cannot tolerate them long term,” said Dr. Asim Khan, rheumatologist at Voyage Healthcare with clinics in Maple Grove and Crystal, MN. “The SetPoint Therapy gives me something fundamentally different to offer those patients: a one-time implant that modulates inflammation through the neuroimmune system. Being able to offer my RA patients a device-based treatment option is a meaningful addition to how I practice.”
RA is a chronic autoimmune disease in which the immune system mistakenly attacks the lining of the joints, resulting in pain, swelling, stiffness and progressive joint damage. An estimated 1.5 million adults in the United States live with RA. While introduction of biological therapies over two decades ago improved clinical outcomes, many patients continue to experience inadequately controlled disease or are unable to tolerate existing therapies, highlighting the need for additional, novel treatment options.
The milestone brings a new, device-based treatment approach to RA patients in the Twin Cities, Rochester and surrounding communities as rheumatology practices, neurosurgeons and surgical centers continue to expand access to SetPoint Therapy across the United States.
“Treating the first patient in Minnesota represents another meaningful step forward in expanding access to neuroimmune modulation for people who continue to struggle with RA,” said Murthy Simhambhatla, Ph.D., president and CEO of SetPoint Medical. “The availability of a new, FDA-approved treatment modality offers them an important option. We are grateful to the physicians and care teams who are helping to bring this therapy to patients in the state.”
The SetPoint System uses a miniaturized, implantable integrated neurostimulator to deliver targeted stimulation to the left vagus nerve, activating the body’s inflammatory reflex to help regulate immune activity associated with RA. The system includes a wireless charger worn around the neck for a few minutes each week for convenient at-home recharging, and a programming application that enables rheumatologists to customize therapy for individual patient needs.
Minnesota joins a growing number of U.S. states where patients can access SetPoint Therapy. SetPoint Medical continues to collaborate with leading healthcare providers, rheumatology practices and surgical practices nationwide to make this new treatment modality available to more patients.
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.
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