SetPoint Expands FDA-Approved Rheumatoid Arthritis Therapy to North Carolina
SetPoint Medical, a commercial-stage medical technology company focused on advancing treatment options for individuals with chronic autoimmune disorders, has announced the successful completion of the first implantation of the SetPoint System in North Carolina. The procedure was carried out in partnership with Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), the largest independent rheumatology practice in the Southeastern United States. The patient was referred by Dr. Ashley Toci, MD, FACR, CCD, a rheumatologist at AOCC.
This milestone represents another advancement in SetPoint Medical's nationwide expansion efforts, increasing patient access to the first and only vagus nerve-mediated neuroimmune modulation therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis (RA).
The SetPoint System is intended for adults with moderate to severe rheumatoid arthritis who have not achieved adequate results from, or are unable to tolerate, biologic or targeted RA medications. The treatment introduces a novel, drug-free approach by using an implanted device that stimulates the vagus nerve, thereby activating the body's natural anti-inflammatory mechanisms.
According to Dr. Gordon K.W. Lam, MD, FACR, a rheumatologist at AOCC and investigator in the RESET-RA clinical study, the first use of SetPoint Therapy in North Carolina marks a significant development in the treatment of rheumatoid arthritis. He noted that despite substantial progress in RA therapies, many patients continue to experience ongoing disease activity or must try multiple treatment options before finding relief. Dr. Lam emphasized that neuroimmune modulation offers a completely new therapeutic strategy by harnessing the body's own neural pathways to manage inflammation. He added that the SetPoint System has the potential to redefine RA treatment and that AOCC is pleased to offer the therapy at its Midtown and Ballantyne locations in Charlotte.
Murthy Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical, stated that expanding access to SetPoint Therapy in North Carolina highlights the increasing acceptance of neuroimmune modulation as an innovative treatment approach for rheumatoid arthritis. He credited the progress to collaborative efforts by physicians such as Dr. Lam and Dr. Toci, who are working across specialties to provide patients with scientifically validated treatment alternatives. Simhambhatla further noted that as the company broadens availability throughout the Southeast and across the United States, it remains committed to partnering with leading healthcare professionals to establish neuroimmune modulation as a distinctive option for patients seeking alternatives to conventional drug therapies.
The FDA approved the SetPoint System in 2025. The device is designed to deliver a one-minute stimulation to the vagus nerve each day, triggering neural pathways involved in regulating inflammation. Findings from the pivotal RESET-RA clinical trial demonstrated significant improvements in disease activity among rheumatoid arthritis patients, supporting the therapy's potential to address an important unmet medical need.
This milestone represents another advancement in SetPoint Medical's nationwide expansion efforts, increasing patient access to the first and only vagus nerve-mediated neuroimmune modulation therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis (RA).
The SetPoint System is intended for adults with moderate to severe rheumatoid arthritis who have not achieved adequate results from, or are unable to tolerate, biologic or targeted RA medications. The treatment introduces a novel, drug-free approach by using an implanted device that stimulates the vagus nerve, thereby activating the body's natural anti-inflammatory mechanisms.
According to Dr. Gordon K.W. Lam, MD, FACR, a rheumatologist at AOCC and investigator in the RESET-RA clinical study, the first use of SetPoint Therapy in North Carolina marks a significant development in the treatment of rheumatoid arthritis. He noted that despite substantial progress in RA therapies, many patients continue to experience ongoing disease activity or must try multiple treatment options before finding relief. Dr. Lam emphasized that neuroimmune modulation offers a completely new therapeutic strategy by harnessing the body's own neural pathways to manage inflammation. He added that the SetPoint System has the potential to redefine RA treatment and that AOCC is pleased to offer the therapy at its Midtown and Ballantyne locations in Charlotte.
Murthy Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical, stated that expanding access to SetPoint Therapy in North Carolina highlights the increasing acceptance of neuroimmune modulation as an innovative treatment approach for rheumatoid arthritis. He credited the progress to collaborative efforts by physicians such as Dr. Lam and Dr. Toci, who are working across specialties to provide patients with scientifically validated treatment alternatives. Simhambhatla further noted that as the company broadens availability throughout the Southeast and across the United States, it remains committed to partnering with leading healthcare professionals to establish neuroimmune modulation as a distinctive option for patients seeking alternatives to conventional drug therapies.
The FDA approved the SetPoint System in 2025. The device is designed to deliver a one-minute stimulation to the vagus nerve each day, triggering neural pathways involved in regulating inflammation. Findings from the pivotal RESET-RA clinical trial demonstrated significant improvements in disease activity among rheumatoid arthritis patients, supporting the therapy's potential to address an important unmet medical need.
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