Setpoint Medical is a clinical-stage healthcare company dedicated to transforming the treatment landscape for chronic autoimmune diseases. The company is developing an innovative platform that utilizes targeted electrical stimulation to regulate inflammation and restore balance within the immune system. This new approach aims to provide an alternative to traditional drug therapies for individuals living with these challenging conditions.
Understanding Neuroimmune Modulation
The scientific foundation of Setpoint Medical’s work lies in neuroimmune modulation, a process that leverages the body’s intrinsic ability to control inflammation. This approach centers on the vagus nerve, a major component of the parasympathetic nervous system that extends from the brainstem to various organs, including those involved in immune responses. The vagus nerve plays a significant role in the “inflammatory reflex,” a neural pathway that helps regulate the body’s inflammatory response.
When the vagus nerve is stimulated, it activates a pathway known as the cholinergic anti-inflammatory pathway (CAP). This pathway involves the release of acetylcholine, a neurotransmitter, which then interacts with specific receptors (alpha-7 nicotinic acetylcholine receptors or α7nAChR) found on immune cells, such as macrophages. This interaction can reduce the production of pro-inflammatory cytokines, which are signaling molecules that contribute to inflammation. This modulation aims to restore a more balanced immune state and reduce chronic inflammation.
The Setpoint Medical Technology
Setpoint Medical has developed a specialized system to deliver this targeted neuroimmune modulation. The core of their technology is an implantable “microregulator” device, which is roughly the size of a multivitamin capsule. This small neurostimulator is designed to generate precise electrical pulses directly to the vagus nerve. The implantation procedure is an outpatient surgery, lasting approximately 60 to 90 minutes, where the device is placed on the left vagus nerve through a small incision in the neck.
The system also includes a wireless charger, allowing patients to recharge the implanted device conveniently. A physician-controlled iPad prescription application completes the system, enabling healthcare providers to program the microregulator for precise, automatic daily dosing. This automated delivery aims to improve patient adherence to the therapy.
Targeting Chronic Autoimmune Conditions
Setpoint Medical’s neuroimmune modulation platform is specifically designed to address chronic autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease (including Crohn’s disease). Autoimmune diseases occur when the body’s immune system mistakenly attacks its own healthy tissues, leading to chronic inflammation. Regulating this inflammation is a primary goal in managing these conditions.
For instance, in rheumatoid arthritis, excessive inflammation causes joint pain and damage. In multiple sclerosis, inflammation contributes to the damage of the myelin sheath, the protective layer around nerve fibers, leading to neurological symptoms. For inflammatory bowel disease, uncontrolled inflammation affects the gastrointestinal tract. This approach seeks to reduce the underlying inflammation characteristic of these conditions.
The Clinical Journey and Patient Impact
Setpoint Medical is currently a clinical-stage company, with its technologies undergoing rigorous testing in human studies to evaluate their safety and effectiveness. For example, the company has completed proof-of-concept and feasibility studies for rheumatoid arthritis and Crohn’s disease, and is conducting a pivotal trial called RESET-RA for rheumatoid arthritis. This randomized, sham-controlled study has enrolled participants with moderate-to-severe rheumatoid arthritis.
The company’s neuroimmune modulation platform aims to offer an alternative to traditional drug therapies, which can carry risks or have cost implications. This bioelectronic approach offers a new treatment option for patients who may not respond adequately to or tolerate existing medications, particularly those with incomplete responses to biologic or targeted synthetic disease-modifying anti-rheumatic drugs. The goal is to provide a therapy that can modulate inflammation while preserving immune surveillance against infections, differing from some immunosuppressive drug therapies.