THE SETPOINT MEDICAL PLATFORM: ADVANCED, INTEGRATED APPLICATIONS OF BIOELECTRONIC THERAPY
ADVANCING THE POSSIBILITIES AT THE FRONTIER OF BIOELECTRONIC MEDICINE
SetPoint Medical has conducted early clinical studies to better understand the safety and efficacy of bioelectronic medicine as a real alternative to treat conditions including Rheumatoid Arthritis and Crohn’s disease.
Traditional pharmacologic and biologic therapies offer significant drawbacks in terms of potential side effects and diminished efficacy over time.
With Rheumatoid Arthritis (RA), the body’s immune system attacks its own tissue, including joints, often resulting in pain, diminished function, bone erosion and joint deformity if not managed appropriately.
More than 1.5M Americans suffer from rheumatoid arthritis. Current immunosuppressive therapies and biologics used to manage RA cost almost $30B annually. SetPoint Medical believes there is a better way through lower-cost therapies that don’t lose efficacy over time.
EUROPEAN PROOF-OF-CONCEPT STUDY
SetPoint Medical first announced positive results from the first-ever, proof-of-concept human study using an implanted vagus nerve stimulator to treat rheumatoid arthritis at the American College of Rheumatology Annual Meeting in 2012. For A comprehensive analysis of the results of this European study, see the write up in Proceedings of the National Academy of Sciences.
U.S. PILOT STUDY
SetPoint Medical has conducted a pilot study utilizing its proprietary bioelectronic device to treat rheumatoid arthritis in the US. This Pilot Investigational Device Exemption (IDE) study was conducted with guidance from the U.S. Food & Drug Administration (FDA) to evaluate the MicroRegulator device in patients with drug refractory rheumatoid arthritis.
Dr. Burrill B. Crohn first described this eponymous disease in 1932, as part of a group of conditions known as inflammatory bowel diseases (IBD) that causes chronic inflammation of the gastrointestinal tract. Crohn’s disease may affect as many as 780,000 Americans.
PROOF OF CONCEPT STUDY
SetPoint Medical has conducted proof-of-concept study using bioelectronic medicine to treat Crohn’s disease in 16 patients in Europe. The company recently presented positive results from this study at Digestive Disease Week in 2018 showing that there were significant reductions in disease activity as assessed by the Crohn’s Disease Activity Index (CDAI).
In addition to clinical studies in RA and Crohn’s disease, SetPoint Medical is currently studying the potential of bioelectronic medicine on demylination and remyelination in an animal model of multiple sclerosis (MS).
MS is an immune-mediated disorder that results in the destruction of the myelin sheath and nerve fibers, causing neurodegeneration and a cascade of serious and debilitating symptoms, including the loss of vision, vertigo, difficulty walking, pain, and depression.
EARLY PRECLINICAL RESULTS IN MS
Early preclinical results highlight that a single dose of bioelectronic medicine not only reduced demyelization, but also accelerated remyelination, often considered the holy grail in MS treatment.
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.