SetPoint Medical has now received approval from the US Food and Drug Administration (FDA) for its implant-based therapy for rheumatoid arthritis. This marks the first time a neuroimmune treatment via the vagus nerve has been approved for this patient group. It is a major milestone for the field and for Kevin Tracey, the pioneer behind the research that showed how the nervous system can regulate inflammation.

The therapy involves daily stimulation of the left vagus nerve using an implanted pulse generator in the neck. In the phase 3 clinical trial RESET-RA, 243 patients received implants across approximately 40 clinical sites in the US. Participants received one minute of stimulation per day for twelve weeks in a placebo-controlled design, followed by twelve weeks of open-label treatment. After that, patients are followed long-term to study lasting effects.

The results showed clinical efficacy without impact on cardiac function, a risk that had initially been considered. Serious adverse events were reported in 1.7 percent of participants, primarily related to vocal cord issues linked to the recurrent laryngeal nerve, a known surgical risk in the neck area. In The Great Nerve, Kevin Tracey estimated that the total cost of SetPoint’s therapy could range from $50,000 to $80,000 per patient, including both the device and surgical implantation. No official pricing has yet been published.

At the INMEST Foundation, we support a simpler and more affordable approach that can be used at home, without surgery or invasive procedures, yet based on the same core principle: modulating the immune system through the nervous system. Our goal is to make this type of therapy more accessible, without compromising on safety or efficacy.

Read more:
Clinical trial on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04539964
SetPoint press release (July 31, 2025): https://setpointmedical.com/setpoint-medical-receives-fda-approval-for-novel-neuroimmune-modulation-therapy-for-rheumatoid-arthritis/