SetPoint Medical Announces First SetPoint® System Procedures in New Mexico, Performed at University of New Mexico Hospital
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FDA-approved neuroimmune modulation therapy is now available to eligible adults living with rheumatoid arthritis across New Mexico.

SANTA CLARITA, Calif., Nov. 3, 2026 /PRNewswire/ -- SetPoint® Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced the completion of the first SetPoint System procedures in New Mexico. The procedures were performed at University of New Mexico Hospital (UNM Hospital) in Albuquerque by neurosurgeon James Botros, M.D., who was also a surgical investigator in the RESET-RA study.

The SetPoint System 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) who have had an inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). It includes a miniaturized implantable neurostimulator that delivers targeted stimulation to the left vagus nerve, activating the body's innate anti-inflammatory pathways to help regulate the immune activity associated with RA. Patients charge the device at home using a wireless charger worn around the neck for a few minutes each week.

"Treating rheumatoid arthritis has not traditionally been part of a neurosurgeon's practice, and that is what makes this therapy so different," said Dr. Botros. "The vagus nerve plays an important role in regulating inflammation, and the SetPoint System allows us to engage that pathway directly. Having worked with this system since its clinical investigation, I look forward to seeing this collaboration with rheumatology continue to grow at UNM Hospital."

RA is a chronic autoimmune disease in which the immune system attacks healthy joint tissue, causing pain, swelling and bone erosion that can progress to deformity, reduced mobility and lasting disability. An estimated 1.5 million adults in the United States live with RA. There is no cure, and many patients continue to experience inadequately controlled disease or are unable to tolerate existing therapies, highlighting the need for novel treatment options.

The first patient treated with SetPoint System in New Mexico was referred by Hillary Norton, M.D. a rheumatologist and medical director at Inspire Santa Fe Medical Group. "Despite the number of advanced therapies available today, a significant group of my patients continue to live with active disease, side effects, or both," said Dr. Norton. "The SetPoint System gives those patients a treatment that works through a different mechanism than anything they have tried before, and that is an important addition to how we treat RA."

"Completing the first SetPoint System procedure in New Mexico adds another state to the growing list where SetPoint Therapy is available, and reflects our commitment to expanding access to neuroimmune modulation for people living with rheumatoid arthritis," said Murthy V. Simhambhatla, Ph.D., president and CEO of SetPoint Medical. "We are grateful to Dr. Botros, Dr. Norton and their teams for helping move RA care forward and for their commitment to people living with this disease."

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.

Dr. Botros and Dr. Norton have not been compensated in connection with this press release.

SOURCE SetPoint Medical

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QA FAIL (need review): The TARGET contains a partial factual error: it states that RA 'can progress to bone erosion' but the SOURCE says RA causes pain, swelling, and bone erosion, which can then progress to deformity, reduced mobility, and lasting disability. This is an unsupported progression claim.
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<p>FDA-approved neuroimmune modulation therapy is now available to eligible adults living with rheumatoid arthritis across New Mexico. SANTA CLARITA, Calif., Nov. 3, 2026 /PRNewswire/ -- SetPoint® Medical, a commercial-stage medical technology company dedicated to improving care for people...</p>

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