Pioneer Neuroimmune Modulation

Neuroimmune modulation is a treatment approach that activates neural pathways to modulate the immune system. For conditions like rheumatoid arthritis, or RA, this can be achieved by electrically stimulating the vagus nerve. The SetPoint System includes a small, rechargeable, integrated neurostimulator enclosed in a ceramic and titanium case that is placed directly on the left vagus nerve to deliver precise electrical pulses to treat RA. Rheumatology providers determine personalized, automatic dosing through an iPad application. Patients recharge the device at their convenience using a wireless charger.

There is established evidence that chronic inflammation plays a role in causing and advancing many autoimmune diseases including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis, and multiple sclerosis. The immune system plays a critical role in fighting infection and maintaining a balanced state in inflammatory pathways.

Recent discoveries have indicated vagus-nerve mediated pathways play a significant role in maintaining this balance, and their dysfunction may be contributing to uncontrolled inflammation.

The SetPoint System includes a small, rechargeable, integrated neurostimulator enclosed in a ceramic and titanium case that is placed directly on the left vagus nerve to deliver precise electrical pulses to treat RA. Rheumatology providers determine personalized, automatic dosing through an iPad application. Patients recharge the device at their convenience using a wireless charger.

Over the past 20 years, SetPoint’s researchers have identified the specific fibers in the vagus nerve and defined the precise stimulation parameters to activate the anti-inflammatory and immune-restorative pathways to balance the immunologic setpoint. Biomarker analysis indicated that a single one-minute stimulation with SetPoint’s proprietary pulse parameters downregulated inflammation for more than 24 hours. 

More importantly, this approach suppressed inflammatory cytokines by 30-70% without eliminating their bioavailability, thereby reducing inflammation with the potential to be less immunosuppressive compared to currently available drugs. The SetPoint System is the only FDA-approved neuroimmune modulation device to treat RA for adults with active disease and inadequate response or intolerance to one or more biologics or targeted synthetic drugs.

The SetPoint System is the only medical device clinically proven to be effective and safe for the treatment of RA.