SetPoint Medical Touts Positive Data from Arthritis Neurostim Study

SetPoint Medical has released positive topline results from its landmark RESET-RA clinical study, which is evaluating the SetPoint System as a first-of-its-kind neuroimmune modulation treatment for moderate-to-severe rheumatoid arthritis (RA) who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

The RESET-RA study enrolled 242 patients at 41 U.S. sites. After the primary endpoint’s completion at 12 weeks, the stidu will evaluate long-term safety and effectiveness in an open-label extension study.

The study’s primary endpoint was met, with a statistically significant greater population of participants gaining an ACR20 response in the treatment group compared to the control group at 12 weeks. ACR20 response is a composite measure of RA treatment effectiveness put forth by the American College of Rheumatology.

No safety concerns were observed during the first 12 weeks and long-term followup. Adverse event rates were low for the implant procedure and stimulation.

SetPoint’s system includes an implantable, rechargeable neurostim device that electrically stimulates the vagus nerve once a day to activate innate anti-inflammatory and immune-restorative pathways, offering the potential to treat autoimmune conditions like RA without the immunosuppressive risks associated with pharmacological therapies. After placement during an outpatient procedure, the SetPoint System is programmed to automatically deliver therapy on a preset schedule to improve compliance and persistence with therapy.

SetPoint’s neuroimmune modulation platform was also awarded Breakthrough Device Designation and accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in March 2024 for the treatment of relapsing-remitting multiple sclerosis (RRMS).

“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, Ph.D., CEO of SetPoint Medical. “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.”