SetPoint Medical: A neurostimulator for the treatment of rheumatoid arthritis

History

2024: Product Announcement

In mid-December 2024, the American company SetPoint Medical introduced a neuroimmune modulation device for the treatment of moderate to severe rheumatoid arthritis. Her task force is patients who respond poorly to standard therapy and patients who do not tolerate biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

SetPoint has developed a rechargeable neurostimulator to electrically stimulate the vagus nerve once a day. It activates innate anti-inflammatory and immune repair pathways, thereby helping to reduce the severity of inflammation that underlies rheumatoid arthritis. The device is implanted during an outpatient procedure, and then the system automatically conducts therapy according to a given schedule depending on the patient's complaints.

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The company claims that this device can be used in the treatment of a wide variety of autoimmune diseases without the risks of immunosuppression associated with standard pharmacotherapy. The SetPoint Medical neurostimulation system has already received the title of a breakthrough device, and shortly before that, the new technology was included in the pilot project Total Product Life Cycle Advisory Program (TAP).

We remain true to our goal, addressing unmet challenges in the treatment of rheumatoid arthritis, and look forward to working with regulators to review the system's pre-registration application, "said Alexis Dinin, vice president of regulatory affairs at SetPoint Medical..

Favorable results from the RESET-RA study were used as a rationale for the system pre-registration application, but regulatory authorities have not yet responded.^[1]

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