SetPoint Medical

Country:
USA
Founding year:
2006

SetPoint Medical develops an implantable neuroimmune modulation therapy for rheumatoid arthritis. The company sits within bioelectronic medicine and therapeutic neuromodulation, applying vagus nerve stimulation to chronic autoimmune inflammation. Its approved indication covers adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic disease-modifying antirheumatic drugs.

The SetPoint System is a small implantable device placed on the left vagus nerve. It delivers once-daily electrical stimulation intended to activate endogenous anti-inflammatory and immune-restorative pathways. The device received FDA approval in 2025, making it one of the first regulated neuroimmune modulation therapies for rheumatoid arthritis.

SetPoint targets patients treated through rheumatology and surgical implantation pathways, with therapy delivered as a device-based alternative within autoimmune disease care. The company is now commercial-stage and is also evaluating its platform for additional autoimmune indications, including multiple sclerosis and Crohn’s disease. It is best understood as one of the most clinically advanced examples of bioelectronic medicine moving into immune-mediated disease.

Neuromodulation
Therapeutics
Clinical Workflows

Neurofounders Insights

Modality:
VNS
Form Factor:
Implant
Interface Depth:
Implantable
Indication:
Other
Target user:
Patients
Regulatory stage:
FDA approved (PMA)

Series C+

SetPoint Medical sits in one of the more clinically advanced areas of bioelectronic medicine, using implantable VNS to modulate inflammatory pathways in rheumatoid arthritis. Its positioning is notable because it places neuromodulation inside immune-mediated disease, expanding the category beyond conventional neurological applications.

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