SetPoint Medical has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Breakthrough Device Designation for its pioneering neuroimmune modulation platform designed for individuals suffering from relapsing-remitting multiple sclerosis (RRMS). This designation offers valuable benefits, including enhanced communication and prioritized regulatory review with the FDA, as well as facilitating reimbursement and patient access upon eventual FDA approval.
Multiple sclerosis (MS) is a chronic autoimmune condition impacting close to one million people in the United States. It results in damage to the myelin sheath, leading to disruptions in nerve signals and a range of debilitating symptoms such as impaired vision, mobility issues, sensory disturbances, pain, cognitive impairment, and fatigue. Current treatments focus on managing symptoms and slowing disease progression but do not address the underlying cause of myelin sheath damage.
Recognizing the urgent need for more effective treatments, the FDA established the Breakthrough Devices Program to expedite access to innovative medical devices for conditions with severe consequences. SetPoint's technology has been acknowledged under this program due to its potential to offer a more impactful treatment compared to existing options.
SetPoint's approach involves targeting the vagus nerve with an integrated neurostimulation device. This device is implanted during a minimally invasive outpatient procedure, with programming to deliver therapy automatically on a predetermined schedule, stimulating the vagus nerve once daily. By modulating the inflammatory reflex through vagus nerve stimulation, the treatment aims to mitigate demyelination and promote remyelination, addressing the underlying pathology of MS.
This Breakthrough Device Designation underscores the promise of SetPoint's technology in addressing the unmet needs of RRMS patients. Further clinical development and regulatory review will be crucial steps in bringing this innovative treatment to fruition and providing relief to individuals affected by this debilitating condition.
Source: https://www.businesswire.com/news/home/20240312565943/en/SetPoint-Medical-Receives-FDA-Breakthrough-Device-Designation-for-its-Neuroimmune-Modulation-Platform-for-the-Treatment-of-Multiple-Sclerosis
