SetPoint Medical Awarded FDA Breakthrough Nod to Treat Multiple Sclerosis

SetPoint Medical has earned breakthrough status from the U.S. Food and Drug Administration to use its novel neuroimmune platform for people with relapsing-remitting multiple sclerosis (MS).
 
There’s currently not a cure for MS. Approved medicines can help slow disease progression and ease some of the symptom but there’s no approved treatments to address root cause of MS, damage to the myelin sheath.
 
The FDA also awarded breakthrough status to SetPoint’s device to treat rheumatoid arthritis (RA) in 2020. The company is evaluating its investigational platform technology in the RESET-RA pivotal trial to treat adults with moderate-to-severe RA. The device uses vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat inflammation-mediated autoimmune conditions.
 
The device is placed on the vagus nerve through a small incision on the left side of the neck in an outpatient procedure. It’s then programmed to automatically deliver therapy on a preset schedule by stimulating the vagus nerve once a day to activate the inflammatory reflex for a systemic immune-restorative effect.
 
“This significant milestone highlights the platform potential of SetPoint’s device and therapeutic approach for the treatment of multiple chronic conditions,” said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. “As next steps, we look forward to working collaboratively with the FDA to initiate the first-of-its-kind clinical trial to investigate our device for people living with RRMS.”