The first-ever neuroimmune modulation implant has been approved for people with moderate to severe rheumatoid arthritis (RA) who haven't found relief with traditional medications. It's a potentially life-changing technology that can zap pain by delivering one-minute electrical pulses to the vagus nerve – a key neural pathway that regulates inflammation.
The US Food and Drug Administration (FDA) has greenlit the device developed by California's SetPoint Medical, based on positive outcomes from the RESET‑RA clinical trial – a 242-patient, randomized, double-blind, sham-controlled study. It showed measurable improvements in disease activity by three months, with sustained benefits at 12 months. Impressively, 75% of participants were using just the implant and no other therapeutics after just 12 months.
We covered earlier trial stages of the device, which is about the size of a vitamin or coffee bean, back in 2021. However, the SetPoint System has been in development for two decades.
The tiny device takes the form of a miniature neurostimulator enclosed in a ceramic and titanium case. It is implanted in the left side of the neck via a minimally invasive outpatient procedure, under anesthetic.
It then delivers electrical stimulation to the vagus nerve once a day for up to a decade, activating the innate anti-inflammatory and immune-restorative pathways to block the dysfunctional signaling that causes the pain. Patients use a digital platform that tailors pulse dosage to their needs, and it can be recharged wirelessly once a week via a collar-like neckband.
The system marks a huge moment in bioelectronic medicine technology, using the body's natural neural circuits to fight disease. This device has shown to be well-tolerated – reported serious adverse events were very low (~1.7%) – and it slashes the costs of ongoing medication to keep the condition in check.
“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” said Murthy V. Simhambhatla, CEO of SetPoint Medical. “We are committed to improving the health of people living with RA, and look forward to working with providers and payers to make our innovative therapy accessible to their patients. We plan to introduce the SetPoint System in targeted US cities this year, followed by expansion across the country starting in early 2026.”
More than 1.5 million Americans live with RA, a chronic autoimmune disease that attacks healthy tissue, causing joint pain, bone erosion, reduced mobility and long-term disability. While there's no cure for RA, this implant is a game-changer for sufferers who have struggled with traditional treatments – up to 50% of people on medication stop the drugs within two years, mostly due to diminishing returns or adverse side effects.
“The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease, by harnessing the body’s neural pathways to combat inflammation,” said Mark Richardson, MD, Director of Functional Neurosurgery at Massachusetts General Hospital, and national surgical principal investigator in the RESET-RA study. “After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA.”
Now, SetPoint Medical is planning to adapt the technology to treat other autoimmune conditions including multiple sclerosis and Crohn’s disease. Vagus nerve stimulation (VNS) is a growing area of study, and back in 1997, the FDA approved VNS for epilepsy. It's expected to be a big player in treating chronic pain in the near future, assisting the brain in dialing down pain signals and naturally suppressing inflammation that results from the haywire neuronal messaging.
Recent studies have found that VNS can relieve other conditions, including treating osteoarthritic knee pain.
“This is a landmark study in the treatment and care of rheumatoid arthritis,” said John Tesser, MD, principal investigator of the RESET-RA study. “The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”
The results of the RESET-RA study, which led to the FDA approval, are published in the journal Bioelectronic Medicine.
Source: SetPoint Medical
