RESET-RA evaluates the SetPoint system as a potential first-of-its-kind treatment for moderate-to-severe RA. Subjects are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). The study includes 242 patients across 41 U.S. sites.
The study met its primary endpoint with a statistically significant greater proportion of study participants achieving an ACR20 response in the treatment group compared with the control group at 12 week. ACR20 measures the effectiveness of RA treatments. Additionally, the study reported no safety concerns during the first 12 weeks and long-term follow-up.
Adverse event rates came in low for both the implant procedure and stimulation therapy, according to a news release. SetPoint Medical labeled the overall treatment effective and well-tolerated.
The company designed its rechargeable neurostimulation device to electrically stimulate the vagus nerve once daily. It activates the innate anti-inflammatory and immune-restorative pathways. SetPoint said it could potentially treat autoimmune conditions without the immunosuppressive risks associated with pharmacological therapies. After placement during an outpatient procedure, the system automatically delivers therapy on a preset schedule to improve compliance.
SetPoint Medical has FDA breakthrough device designation for its system. Earlier this year, the FDA accepted the technology into its Total Product Life Cycle Advisory Program (TAP) pilot.
“We are thrilled with the results from the RESET-RA study as they highlight the potential of the SetPoint System for providing rheumatologists and their patients with a safe and effective treatment alternative to current rheumatoid arthritis therapies,” said Murthy V. Simhambhatla, SetPoint Medical CEO. “As next steps, we look forward to submitting the data for presentation at upcoming rheumatology and neurosurgical medical meetings, and completing our premarket approval submission to the FDA.”
