advancing the possibilities
A new treatment platform designed to restore the immunologic SetPoint
SetPoint Medical has completed multiple clinical studies to advance neuroimmune modulation as a potential alternative for treatment of chronic autoimmune conditions like Rheumatoid Arthritis (RA) and Crohn’s disease. With FDA approval for treatment of biologic-experienced RA, SetPoint is committed to evidence-based advancement of this novel therapeutic approach.
Rheumatology
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.
More than 1.5M Americans suffer from RA in the US. 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.
RESET-RA Study
SetPoint Medical conducted a 242 patient randomized, double-blind study to evaluate its proprietary device to treat rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to at least one of the RA medications. This Investigational Device Exemption (IDE) study, conducted in accordance with U.S. Food & Drug Administration (FDA) regulations, enrolled patients across various sites across the United States.
Inflammatory Bowel Diesease
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 , and over 250,000 more suffer from Ulcerative Colitis.
Crohn’s Disease Pilot Study
SetPoint Medical has conducted a pilot study using neuroimmune modulation to treat Crohn’s disease in 16 patients in Europe. This data, published in the Journal of Crohn’s and Colitis, demonstrates significant reductions in disease activity as assessed by the Crohn’s Disease Activity Index (CDAI) and quality of life.
Multiple Sclerosis
Multiple Sclerosis (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.
RRMS Pilot Study
Building on extensive preclinical research, SetPoint Medical received U.S. Food and Drug Administration’s (FDA’s) Investigational Device Exemption approval to study the potential of neuroimmune modulation remyelination in relapsing remitting multiple sclerosis (RRMS). The multicenter, randomized, sham-controlled pilot study will be initiated in late 2025 and will enroll up to 60 patients across the United States.