Milestone marks expansion of FDA-approved neuroimmune modulation therapy into Southeast
VALENCIA, Calif., June 29, 2026 /PRNewswire/ -- SetPoint Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that the first SetPoint System® procedure in North Carolina was completed in collaboration with Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), the largest independent rheumatology practice in the Southeast. The patient was referred by Ashley Toci, MD, FACR, CCD, rheumatologist at AOCC. This marks another step in SetPoint Medical's efforts to bring the treatment to patients nationwide, expanding access to the first-and-only U.S. Food and Drug Administration (FDA)-approved vagus nerve-mediated neuroimmune modulation therapy for people living with rheumatoid arthritis (RA).
The SetPoint System is indicated for adults with moderately to severely active RA who do not respond to or cannot tolerate biologic or targeted RA drug therapies. The therapy offers a novel, non-pharmacological approach for patients living with RA, in which a small device is implanted to stimulate the vagus nerve, activating the body's innate anti-inflammatory pathways.
"Treating the first patient with SetPoint Therapy in North Carolina demonstrates meaningful progress in our ability to care for people living with rheumatoid arthritis," said Gordon K.W. Lam, MD, FACR, rheumatologist at AOCC and RESET-RA study investigator. "Despite significant advances in RA care, many patients continue to experience persistent disease activity or cycle through multiple therapies searching for relief. Neuroimmune modulation represents an entirely new therapeutic approach, leveraging the body's own neural pathways. The SetPoint System has the potential to reshape the treatment landscape for people living with RA, and we are excited to bring this innovative therapy to patients at our Midtown and Ballantyne locations in Charlotte."
"Expanding access to SetPoint Therapy in North Carolina reflects the growing momentum behind neuroimmune modulation therapy and our mission to transform the treatment of rheumatoid arthritis," said Murthy Simhambhatla, Ph.D., CEO of SetPoint Medical. "This progress is made possible by pioneering physicians such as Dr. Lam and Dr. Toci, who are collaborating across specialties to bring innovative, evidence-based treatment options to patients. As we continue expanding access across the Southeast and throughout the United States, we remain focused on partnering with leading clinicians to establish neuroimmune modulation as a differentiated option for patients seeking alternatives to traditional drug therapies."
The SetPoint System was approved by the FDA in 2025 and is designed to deliver one-minute daily stimulation to the vagus nerve, activating neural pathways that help regulate inflammation. Clinical data from the pivotal RESET-RA study demonstrated meaningful improvements in disease activity among patients with RA, supporting the therapy's potential to address a significant unmet need.
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. Lam is a study investigator and consultant for SetPoint Medical. He has not been compensated in connection with this press release.
View original content to download multimedia:https://www.prnewswire.com/news-releases/arthritis--osteoporosis-consultants-of-the-carolinas-treats-first-patient-in-north-carolina-with-the-setpoint-system-a-device-based-treatment-for-rheumatoid-arthritis-302812650.html
SOURCE SetPoint Medical
