SetPoint System® is first-of-its-kind neuroimmune modulation device for the treatment of adults living with moderate-to-severe rheumatoid arthritis

SetPoint Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for its neuroimmune modulation device, the SetPoint System^®. This approval offers incremental payment for procedures involving the use of the SetPoint System in hospital outpatient and ambulatory surgery center (ASC) settings. The TPT becomes effective January 1, 2026, and will last for up to three years.

Through this approval, CMS created a new device category to describe the SetPoint System, C1607, in the Healthcare Common Procedure Coding System (HCPCS). This differentiated device category acknowledges the novelty of the SetPoint System as the first FDA-approved, non-pharmacologic treatment option for adults living with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to—or are intolerant of—biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).

“We are truly grateful to CMS for their dedication to the health of Medicare beneficiaries,” said Spencer Bailey, MBA, CPC, VP of Market Access at SetPoint Medical. “Following this TPT approval, we plan to engage with providers to implement referral pathways and establish reimbursement infrastructure to support broader launch of the SetPoint System in 2026.”

More than 1.5 million Americans are living with RA, a chronic autoimmune disease with no cure that causes the immune system to mistakenly attack healthy tissue, leading to joint pain, bone erosion, deformity, and long-term disability. Approved by the U.S. Food and Drug Administration (FDA) in July 2025 as part of the Breakthrough Devices Program, the SetPoint System is a fully integrated neuroimmune modulator that is designed to restore the immunologic balance by electrically stimulating the vagus nerve for one minute daily. Once activated, integrated telemetry and a rechargeable battery in the SetPoint Implant are designed to automatically deliver therapy for up to 10 years.

“Receiving TPT is an important milestone for the SetPoint System, as it will enable broader access to our breakthrough therapy by reducing cost barriers for healthcare systems,” said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. “We are committed to advancing care for people living with RA and are proud that CMS, the nation's largest payer for healthcare, recognizes the value of our therapy to its beneficiaries.”

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.

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