World's 1st FDA Approved Bioelectronic Implant for Arthritis

In a groundbreaking move, the U.S. FDA has approved the SetPoint System, the first neuroimmune modulation implant designed to treat moderate to severe rheumatoid arthritis (RA)—especially for patients who haven’t responded well to traditional medications.

What It Is

• A vitamin-sized neurostimulator implanted in the neck via a minimally invasive outpatient procedure.
• Delivers 1-minute daily electrical pulses to the vagus nerve, which helps regulate inflammation and immune response.
• Patients recharge it wirelessly once a week using a collar-like neckband.

Clinical Impact

Based on the RESET-RA trial (242 patients), the device showed:

• Significant improvement in RA symptoms within 3 months.
• Sustained benefits at 12 months.
• 75% of participants were able to stop other RA medications entirely.
• Reported serious adverse events were low (~1.7%).

Why It Matters

• RA affects over 1.5 million Americans, causing chronic pain, joint damage, and disability.
• Traditional treatments like DMARDs and biologics can be costly and lose effectiveness over time.
• This implant offers a non-pharmaceutical, long-term solution—potentially lasting up to 10 years.

Bioelectronic Medicine Milestone

This marks a major leap in bioelectronic medicine, using the body’s own neural circuits to combat disease. SetPoint Medical plans a targeted U.S. rollout in late 2025, with broader availability expected in 2026.

The results of the RESET-RA study, which led to the FDA approval, are published in the journal Bioelectronic Medicine.