FDA

FDA greenlights first neuroimmune device for rheumatoid arthritis

August 7, 2025

FDA has approved SetPoint Medical’s SetPoint System, a first-of-its-kind neuroimmune modulation therapy for adults with moderate-to-severe RA who are refractory to or intolerant of biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). The implantable device stimulates the vagus nerve to activate anti-inflammatory pathways, offering a non-pharmacologic approach to immune regulation.

Approval was based on the RESET-RA trial (NCT04539964), a randomized, double-blind, sham-controlled study involving 242 patients. The trial met its primary endpoint (ACR20 at 3 months), with sustained improvements in disease activity through 12 months. Notably, 75% of participants remained off biologic or targeted synthetic DMARDs at one year.

The device placement procedure and stimulation therapy were well-tolerated, with a low rate of related serious adverse events (1.7%) and no reports of malignancy, major cardiac events, or serious infections.

This device introduces a novel treatment pathway for difficult-to-treat RA, potentially reducing reliance on immunosuppressive drugs and expanding options for patients with limited therapeutic success.

Source:

(2025, July 31). SetPoint Medical. SetPoint Medical Receives FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis. [Press release]. https://setpointmedical.com/setpoint-medical-receives-fda-approval-for-novel-neuroimmune-modulation-therapy-for-rheumatoid-arthritis/