The brief

Analyst view

• SetPoint System: 60-second daily vagus nerve stimulation via vitamin-tablet implant. FDA approved July 2025.
• RESET-RA trial: 35.2% ACR20 at 3mo vs 24.2% sham. 75% off biologics at 1 year. 242 patients, 41 sites.
• August 2025 funding: $140M Series C/D from Elevage, Ally Bridge, NEA, Abbott. Launching select U.S. markets, nationwide 2026.

Technical approach

As reported

Vagal Pulse

Daily 60-second stimulation

Single 60-second electrical pulse to vagus nerve once daily. Scheduled, consistent dose without pill complexity.

Anti-Inflammatory

Cholinergic pathway suppresses inflammation

Vagal signals trigger acetylcholine release, activating nicotinic receptors on immune cells. Suppresses pro-inflammatory cytokines driving RA.

Minimal Surgery

Vitamin-tablet sized implant

25mm integrated neurostimulator with single lead. Smaller than prior devices, less surgical trauma, faster recovery.

Biologic Reduction

Enables drug-free or low-dose therapy

Reduces inflammation enough to let most patients stop or reduce biologics, cutting side effects and costs.

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