SetPoint Medical has announced the submission of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its novel neuroimmune modulation device designed for the treatment of moderate-to-severe rheumatoid arthritis (RA). This system offers a potential first-of-its-kind treatment for patients who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
Vagus Nerve Stimulation for RA Treatment
The SetPoint System employs a rechargeable neurostimulation device that electrically stimulates the vagus nerve. This stimulation aims to activate the innate anti-inflammatory and immune-restorative pathways, potentially treating autoimmune conditions without the immunosuppressive risks associated with pharmacological therapies. The device is implanted during an outpatient procedure and is programmed to automatically deliver therapy on a preset schedule to improve patient compliance.
Clinical Evidence from RESET-RA Study
The PMA submission is supported by data from the RESET-RA study, a multicenter, randomized, sham-controlled, double-blind pivotal trial. The study enrolled 242 patients in the U.S. and met its primary endpoint, demonstrating a statistically significant greater proportion of study participants receiving SetPoint System therapy achieving an ACR20 response compared to the control group at 12 weeks. An ACR20 response is a composite measure of the effectiveness of RA treatments used in clinical trials.
SetPoint stated the results “demonstrated the potential of the SetPoint System to provide a safe and effective treatment alternative for RA patients who do not respond to or cannot tolerate the current standard of RA care.”
Addressing Unmet Needs in RA Treatment
Alexis Dineen, VP of Regulatory Affairs for SetPoint Medical, stated, “We remain steadfast in our goal to address the unmet medical needs in RA treatment and look forward to continuing to work cooperatively with the FDA during the upcoming PMA review process.”
Market Context and Future Prospects
The neuromodulation market is expanding, offering alternatives to traditional medication. GlobalData forecasts the global neuromodulation device market will be worth $12.6 billion by 2033, up from a $6.6 billion estimate in 2022. SetPoint's device has received Breakthrough Device Designation, potentially leading to a prioritized review. The company is also exploring the use of its device for relapsing-remitting multiple sclerosis (RRMS), with a clinical trial planned for 2025.
