DISCLAIMER: The information on this page reflects individual responses from clinical studies of bioelectronic medicine. The accounts given are genuine and documented. Each story represents a unique individual experience and does not provide any indication, guide, warranty or guarantee as to the response other people may have to these and related therapies. The response other individuals have could be different. Responses can and do vary. The SetPoint Medical device is an investigational device. The SetPoint Medical device is an investigational device. Its use is limited by United States law to investigational use. It is not approved for commercial use.
BIOELECTRONIC MEDICINE: MILESTONES ON THE WAY TO MEDICAL REVOLUTION
“After the implant, I started to do things I hadn’t done in years – like taking long walks or just putting clothes on in the morning without help. I was ecstatic.” – Mirela Mustacevic
BATTLING CROHN'S DISEASE WITH VAGUS NERVE STIMULATION
A woman debilitated from Crohn's disease tells how vagus nerve stimulation changed her life.
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CURRENT CLINICAL TRIALS
The RESET-RA study is designed to evaluate the safety and efficacy of SetPoint Medical’s Vagus Nerve Stimulation (VNS) device for the treatment of adult patients with active, moderate-to-severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study is actively enrolling patients in the US.
Rheumatoid Arthritis: US Pilot Study
This multi-site, first-in-human study was designed to assess safety of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two different mechanisms of action. Enrollment for this study is now closed.
INVESTIGATIONAL DEVICE DISCLAIMER: The SetPoint Medical device is an investigational device. It is currently undergoing clinical evaluation under Food and Drug Administration’s Investigational Device Exemption and is not approved for commercial use.