Bioelectronic medicine merges neuroscience and advanced engineering to create new therapeutic approaches by modulating the nervous system. Setpoint Medical is a pioneering company developing systems that treat chronic inflammatory diseases by directly modulating the body’s neural pathways. Their device-based therapy seeks to restore immunological balance, offering an alternative to traditional drug treatments. This approach harnesses the body’s communication systems to regulate the underlying inflammation associated with autoimmune conditions.
The Inflammatory Reflex and Vagus Nerve Signaling
The biological mechanism Setpoint Medical targets is the inflammatory reflex, the body’s natural regulatory circuit for controlling the immune response. This reflex operates as a communication loop between the nervous system and the immune system.
The core pathway runs along the vagus nerve, which connects the brainstem to most internal organs. When the immune system detects inflammation, sensory neurons in the vagus nerve relay this information to the central nervous system. The brainstem then sends a signal back down the vagus nerve, initiating an anti-inflammatory effect.
This descending signal travels to the spleen, a major site for immune cell activity. The signal stimulates T cells within the spleen, which release neurotransmitters that communicate with immune cells like monocytes and macrophages. This acts as a regulatory signal, telling immune cells to decrease their production of pro-inflammatory cytokines. Key inflammatory molecules, such as Tumor Necrosis Factor (TNF), Interleukin-1 beta (IL-1β), and Interleukin-6 (IL-6), are suppressed by this mechanism. Setpoint Medical’s strategy intentionally activates this natural reflex to rebalance the immune system.
The Implantable Bioelectronic Device
Setpoint Medical’s technology, the SetPoint System, is a miniaturized neurostimulation device designed to amplify the body’s natural anti-inflammatory process. The implant is a small, integrated neurostimulator enclosed in a ceramic and titanium case for biocompatibility.
The device is surgically placed on the left cervical vagus nerve, which runs through the neck within the carotid sheath. This minimally invasive procedure typically places the device between the C4 and C6 cervical vertebrae.
Once implanted, the device delivers precise, low-energy electrical impulses directly to the vagus nerve. Stimulation is programmed to occur automatically on a preset schedule, often involving a one-minute daily dose. Patients recharge the device’s battery at home using a wireless charger for a few minutes each week. Clinicians use a separate tablet application to personalize and adjust the stimulation parameters.
Clinical Applications and Trial Status
The SetPoint System has achieved FDA approval for use in adults with moderately to severely active Rheumatoid Arthritis (RA). This approval is specifically for patients who have not responded adequately to, or are intolerant of, one or more biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).
The approval was supported by results from the pivotal RESET-RA study, which enrolled 242 participants. In the study, patients showed clinical improvement in tender and swollen joint counts and overall disease activity within three months of starting stimulation.
The company is also actively pursuing other chronic inflammatory conditions, notably Crohn’s Disease. A pilot study in Europe demonstrated that vagus nerve stimulation resulted in a clinically meaningful reduction in disease activity and improved patient quality of life. Setpoint Medical is also planning to evaluate the platform for other autoimmune indications, including Multiple Sclerosis.
Known risks associated with the implantation procedure include potential side effects related to the vagus nerve, such as hoarseness, coughing, throat irritation, and vocal cord paresis. The device offers a non-immunosuppressive treatment alternative for patients seeking to manage inflammation while preserving their overall immune surveillance.