Milestone underscores continued momentum in commercial rollout and accelerating adoption of neuroimmune modulation as a new option for adults living with Rheumatoid Arthritis
SetPoint Medical has announced the successful completion of the first procedure in Texas using the FDA-approved SetPoint System®, an implantable neuroimmune modulation device designed to treat adults living with moderately to severely active rheumatoid arthritis (RA). The landmark procedure was performed by Dr. Daniel Peterson, MD, FACS, a neurosurgeon at Ascension Dell Seton Medical Center at The University of Texas, representing an important milestone in expanding access to advanced treatment options for rheumatoid arthritis patients in the Southwestern United States.
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The SetPoint System introduces a new approach to treating autoimmune diseases by targeting the body’s neural pathways to regulate inflammation. Unlike conventional rheumatoid arthritis treatments that rely primarily on pharmaceutical therapies, this device-based solution works by stimulating the left vagus nerve to activate the body’s natural anti-inflammatory mechanisms. This innovative technology represents a growing intersection of medical device innovation and AI-enabled healthcare advancements designed to improve patient outcomes.
Dr. Peterson, who also served as the top enrolling investigator in the RESET-RA clinical study, highlighted the significance of the therapy’s precision and engineering design. He noted that the system represents a significant evolution in neuromodulation technology, offering a targeted therapeutic approach that differs from traditional rheumatoid arthritis treatments. The leadless device platform is engineered to interact directly with neural pathways, providing consistent stimulation designed to reduce inflammation and improve clinical outcomes for patients with rheumatoid arthritis.
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The SetPoint System is the first device-based therapy approved in the United States specifically for adults with rheumatoid arthritis who have experienced inadequate response, loss of response, or intolerance to at least one advanced therapy, including biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). For many patients with chronic autoimmune conditions, these limitations can create significant challenges in disease management, highlighting the importance of innovative medical treatment options.
The patient who received the implant at Ascension Dell Seton Medical Center was referred by Dr. Pendleton B. Wickersham, MD, a board-certified rheumatologist at Arthritis Associates in San Antonio. Dr. Wickersham emphasized that the availability of the SetPoint System provides physicians with a new treatment pathway for rheumatoid arthritis patients who require alternative care options. He also highlighted the importance of collaboration between rheumatologists and neurosurgeons in delivering advanced therapies that address complex autoimmune conditions.
Clinical momentum behind the technology continues to grow following the publication of results from the RESET-RA study in Nature Medicine. The study reported clinically meaningful improvements in patients with sustained efficacy observed over a 12-month period, reinforcing the potential of neuroimmune modulation as a long-term therapeutic strategy.
Murthy Simhambhatla, CEO of SetPoint Medical, noted that the successful Texas procedure represents another step in the company’s nationwide expansion of treatment access. According to Simhambhatla, building a strong network of physician partners across the country is essential to ensuring more patients living with rheumatoid arthritis can benefit from this innovative device-based therapy.
As healthcare innovation increasingly integrates advanced medical devices, precision neuromodulation, and AI-driven healthcare research, the SetPoint System represents a promising advancement in the treatment of autoimmune diseases. By offering a new mechanism to regulate inflammation through neural pathways, this therapy could help redefine how rheumatoid arthritis is treated in the future.
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