The emerging field of bioelectronic medicine aims to address unmet patient needs by delivering targeted digital doses to modulate physiological circuits for treatment of diseases historically treated with drugs.
SetPoint Medical is developing a novel bioelectronic medicine platform that stimulates the vagus nerve with digital doses of electricity designed to activate the cholinergic anti-inflammatory reflex to produce a systemic immunorestorative effect.
SetPoint researchers have invested more than four years collaborating with leading surgeons to design an implantable MicroRegulator and positioning device.
Their small, self-contained MicroRegulator generates precise electrical pulses using an integrated circuit, telemetry hardware and a rechargeable battery enclosed in a ceramic and titanium case. Physicians determine precise, automatic dosing through an iPad prescription application and patients recharge the pulse generator at their convenience using a comfortable wireless charger.
The company has published positive results from a first-in-human proof-of-concept trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS).
SetPoint is currently undergoing clinical studies in the United States for rheumatoid arthritis under FDA’s Investigational Device Exemption. In parallel, the company has conducted an additional successful proof-of-concept study in Crohn’s disease as well as promising pre-clinical research in multiple sclerosis. They expect to commercialize its bioelectronic medicine platform following FDA approval of its device.
Watch Kevin Tracey, neurosurgeon and SetPoint’s co-founder share the future of Bioelectronic Medicine