SetPoint Medical, a healthcare company focusing on chronic autoimmune diseases, has secured Breakthrough Device Designation from the FDA for its neuroimmune modulation platform aimed at patients with relapsing-remitting multiple sclerosis (RRMS). This designation facilitates interactive communication and priority regulatory review with the FDA, paving the way for potential reimbursement and improved patient access upon FDA approval of SetPoint’s technology.
Around one million individuals in the United States are coping with multiple sclerosis (MS), an autoimmune condition that harms the myelin sheath, a protective covering around nerve fibers. This damage interrupts communication to and from the brain, leading to neurodegeneration and a range of debilitating symptoms like vision problems, mobility issues, sensory disturbances, pain, cognitive challenges, and fatigue. Despite available treatments that can slow disease progression and alleviate symptoms, there is no cure for MS, and these therapies do not target the underlying cause of myelin sheath damage.
Dr. Shiv Saidha, a Neurology Professor at Johns Hopkins University, acknowledges the progress in developing drugs to manage MS symptoms but highlights the need for therapies that can protect and repair damaged axons by promoting remyelination. SetPoint’s therapeutic approach, which has received Breakthrough Device Designation from the FDA, offers potential hope for individuals with MS by potentially reducing demyelination and promoting remyelination.
The FDA’s Breakthrough Devices Program aims to expedite access to innovative medical devices for conditions like MS. SetPoint’s device, previously designated for rheumatoid arthritis (RA) treatment, is now being evaluated in a pivotal clinical trial, RESET-RA, for adults with moderate-to-severe RA. The device uses precise vagus nerve stimulation to trigger anti-inflammatory and immune-restorative pathways, offering a novel approach to managing autoimmune conditions.
SetPoint Medical’s CEO, Dr. Murthy V. Simhambhatla, views this milestone as a testament to the platform’s potential for treating various chronic conditions. The next step involves collaboration with the FDA to launch a groundbreaking clinical trial for individuals living with MS using SetPoint’s neurostimulation device, which is placed on the vagus nerve to stimulate the inflammatory reflex and achieve immune-restorative effects.
