Stop the
impact of Rheumatoid Arthritis
Tiny but powerful
A small, integrated neurostimulator that is designed to precisely activate immune pathways to restore balance and reduce inflammation, which is the root cause of RA. 1,2
Safe and effective
The SetPoint System is clinically proven to effectively treat RA for adults with moderately to severely active disease and inadequate response or intolerance to one or more biologics or targeted synthetic drugs. Device placement is safe and stimulation is well tolerated.3
Set it and forget it
Once activated, integrated telemetry and a rechargeable battery in the SetPoint Implant ensures that the device automatically delivers therapy for one minute each day—providing peace of mind for those living with RA.
The SetPoint System: A revolutionary new approach to treating RA
The SetPoint System includes a small, rechargeable, integrated neurostimulator enclosed in a ceramic and titanium case that is placed directly on the left vagus nerve to deliver precise electrical pulses to treat RA. Rheumatology providers determine personalized, automatic dosing through an iPad application. Patients recharge the device at their convenience using a wireless charger.
See all the results
Neuroimmune modulation changes the equation of RA care. SetPoint Medical is committed to evidence-based advancement of its therapeutic platform through robust clinical research. RESET-RA study was a landmark clinical trial that demonstrated SetPoint System’s effectiveness and safety for the treatment of RA.
The SetPoint System leverages over 20 years of device development and procedural technique to ensure that its placement and activation are safe and well tolerated.
Get activated. Connect with us directly.
If you are interested in neuroimmune modulation therapy for your RA patients, start activating by contacting your SetPoint representative. Regardless of whether you are a prescribing rheumatologist or implanting surgeon, they’ll walk you through the referral and training process. Once you’ve activated, you’ll be able to offer your biologic-experienced RA patients this novel treatment option.
Frequently asked questions about the SetPoint System
See more answers from the faqsHow does the SetPoint System work?
The SetPoint System is a neuroimmune modulatory device that treats RA and is designed to restore immunologic homeostasis.1,2,4 The SetPoint System consists of an integrated neurostimulator intended to activate innate anti-inflammatory processes to modulate multiple intracellular pathways,1,2,5 thereby reducing production of an array of proinflammatory cytokines6,7—providing a novel treatment option indicated for your biologic-experienced RA patients. The stimulation parameters of the SetPoint System are based on extensive preclinical biomarker analysis that indicated that a single 60-second daily stimulation reduces multiple cytokines, including TNF, IL-1β, and IL-6, by 30-70%, providing symptom reduction without immunosuppressive risks.2,5,6,7
Who is the ideal patient candidate for SetPoint Therapy?
The SetPoint System is indicated for adults with moderately to severely active RA who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease-modifying anti-rheumatic drugs such as TNF inhibitors or JAKinhibitors.
Hence, SetPoint Therapy could be considered for adult RA patients who have failed at least one biologic or JAK inhibitor and are seeking an alternative therapy; those who cannot tolerate these medications; those who are at high safety risks for JAK inhibition due to comorbid conditions; and those who had failed to get adequate disease control on biologics or JAK inhibitors.
In the RESET-RA study, improvement in the number of tender and swollen joints as well as disease activity was seen by 3 months after starting stimulation. This response rate was higher in patients who had exposure to just one prior biologic.
Based on its mechanism of action that manages the inflammatory process without immune suppression, SetPoint Therapy can be combined with biologics or JAK inhibitors if desired, preserving treatment options in the future.1,2,4,5
Is the SetPoint System safe and effective for treatment of RA?
SetPoint System’s unique mechanism of action builds on over two decades of research and engineering, including the clinical experience from other devices that stimulate the vagus nerve, to provide you and your patients with the first neuroimmune modulation therapy for treatment of RA.
The SetPoint System’s safety and effectiveness were studied in the RESET-RA clinical study that enrolled 242 patients who were inadequate responders or intolerant to one or more biologics and/or JAK inhibitors. The study successfully met its primary endpoint of ACR20 at 3 months, with sustained improvements observed through 12 months of follow-up compared to baseline. With 12 months of therapy, nearly half of the patients were in DAS28-CRP low disease activity or remission.*
The SetPoint System, as well as the implant procedure, is considered safe. There was a low risk (1.7% n = 4) of related serious adverse event rate in the peri-operative 3 months, with no (0%) related serious events occurring through 12 months. Additionally, through 12 months, there were no malignancies, major cardiac events, or serious infections associated with the SetPoint System, highlighting the safety of this novel therapeutic option.
To see detailed data, visit the Clinical Evidence page.
*Analysis based on patients who were treated with SetPoint Therapy for 12 months without the addition of biologic, JAK inhibitors or high-dose steroids, or change in csDMARDs.
What is the implant procedure like?
The SetPoint System is typically placed during a 60-to-90 minute outpatient surgical procedure under general anesthesia.8 Patients typically go home the same day as the procedure and resume activities of daily living the following day.
The SetPoint Implant is placed by a surgeon who is experienced with procedures involving the vagus nerve, typically a functional neurosurgeon or an ENT surgeon. Your Territory Manager can help to identify trained surgeons near you. Additionally, SetPoint Medical will assist with the prior authorization process for the SetPoint procedure and will keep you and your patients informed to ensure a best-in-class experience for your patients and your staff.
If you have additional questions, please contact your Territory Manager.
What should patients expect to experience before, during, and after the Implant placement procedure?
The first step of activating your SetPoint Therapy is to discuss this new therapeutic option with your rheumatologist or their team. To check if your rheumatologist offers SetPoint Therapy, please connect with the SetPoint Activator or talk to your rheumatology provider.
Once you and your rheumatology care provider decide that SetPoint Therapy is the right option for managing your RA, they will refer you to a surgeon trained to place the SetPoint Implant. Next step would be to meet with the surgeon for a pre-operative visit to ensure that the procedure is right for you.
The actual placement procedure will be scheduled after your first surgeon appointment. The implant is typically placed during 60-90 minute outpatient procedure, meaning that you typically return home the same day as the procedure and can resume activities of daily living the following day.8 The implant is placed via a small, 1-inch incision near a crease in the skin. You return to the surgeon a few days after the procedure for post-operative check. Click here to see examples of what the scar may look in patients who have had the SetPoint System.
A couple of weeks after the Implant is placed, you return to your rheumatologist who activates your therapy while ensuring that the stimulation is comfortable for you. Once activated, the therapy is automatically delivered daily. All you need to do is charge your device for a few minutes once a week. Your rheumatologist will continue to manage your RA. During these appointments, your therapy can be adjusted, if desired.
While results vary, this is how Lynn, a RESET-RA study participant, described the experience of her Implant placement procedure: “You’re implanted, your little scar heals, and you’re done. It was easily implanted. I had no downtime. I was literally in and out in the same day.”
Watch Lynn’s story.
Explore the SetPoint System
2. Kelly MJ, et al. Manipulation of the inflammatory reflex as a therapeutic strategy. Cell Rep Med. 2022;3(7):100696.
3 Data on file at SetPoint Medical[AS1]
4. van Maanen MA, et al. The cholinergic anti-inflammatory pathway: towards innovative treatment of rheumatoid arthritis. Nat Rev Rheumatol. 2009;5(4):229-232.
5 Chavan SS, et al. Mechanisms and Therapeutic Relevance of Neuro-immune Communication. Immunity. 2017;46(6):927-942.
6. Levine YA, et al. Harnessing the Inflammatory Reflex for the Treatment of Inflammation-Mediated Diseases. Cold Spring Harb Perspect Med. 2020;10(1):a034330.
7. Genovese MC, et al. Safety and efficacy of neurostimulation with a miniaturised vagus nerve stimulation device in patients with multidrug-refractory rheumatoid arthritis: a two-stage multicentre, randomised pilot study. Lancet Rheumatol. 2020;2(9):e527-e538.
8. Peterson D, et al. Clinical safety and feasibility of a novel implantable neuroimmune modulation device for the treatment of rheumatoid arthritis: initial results from the randomized, double-blind, sham-controlled RESET-RA study. Bioelectronic medicine. 2024 10:8.
