SetPoint Medical Announces First SetPoint® System Procedure in Texas, Performed at Ascension Dell Seton Medical Center at The University of Texas

Milestone underscores continued momentum in commercial rollout and accelerating adoption of neuroimmune modulation as a new option for adults living with Rheumatoid Arthritis

VALENCIA, Calif., March 11, 2026 /PRNewswire/ -- SetPoint Medical, a company dedicated to developing therapies for people living with chronic autoimmune diseases, today announced the completion of the first procedure in Texas using the U.S. Food and Drug Administration (FDA)-approved SetPoint System^®, a breakthrough neuroimmune modulation device for adults living with moderately to severely active rheumatoid arthritis (RA). This landmark procedure was performed by Daniel Peterson MD, FACS, neurosurgeon at Ascension's Dell Seton Medical Center at The University of Texas, marking a significant milestone in expanding access to this novel therapy for patients in the Southwest.

"The SetPoint System represents a significant evolution in the application of neuromodulation, offering a highly targeted device-based approach that fundamentally differs from conventional rheumatoid arthritis therapies," said Dr. Peterson, who was also the top enrolling investigator in the RESET-RA study. "From a neurosurgical standpoint, what is particularly compelling is the sophistication of the device design—engineered specifically to engage the neural pathways with a level of precision and consistency that is clinically proven to improve outcomes in rheumatoid arthritis. This integrated, leadless platform reflects a transformative step forward in both implantable device engineering and the therapeutic landscape for rheumatoid arthritis."

The SetPoint System is an implantable neuroimmune modulation device that stimulates the left vagus nerve to activate innate anti-inflammatory pathways. It is the first device-based therapy approved in the United States for the treatment of adults with RA who have had an inadequate response to, loss of response to or are intolerant to at least one advanced therapy, such as biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

The patient treated at Ascension Dell Seton Medical Center was referred by Pendleton B. Wickersham, MD, a board-certified rheumatologist at Arthritis Associates in San Antonio, who stated that "the availability of the SetPoint System offers an innovative treatment approach for RA. Collaborating with surgical partners like Dr. Peterson to bring this therapy to Texas reflects the continued evolution of RA care and our shared commitment to expanding meaningful treatment options for this debilitating condition."

SetPoint Medical continues to build momentum in its commercial rollout. This progress is further reinforced by the recently published  RESET-RA study results in Nature Medicine, which reported clinically meaningful improvements and sustained efficacy through 12 months.

"Momentum is growing across the country," said SetPoint Medical CEO, Murthy Simhambhatla. "Each new center offering the SetPoint System expands patient access to this innovative therapy. Building a strong national network of physician partners who are committed to bringing this differentiated treatment option to individuals living with rheumatoid arthritis is a top priority for SetPoint Medical."

About 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 (RA), 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 setpointmedical.com.

Dr. Daniel Peterson is a study investigator and consultant for SetPoint Medical.  Dr. Pendleton Wickersham is a study investigator for SetPoint Medical. They have not been compensated in connection with this press release.

SOURCE SetPoint Medical