SetPoint Medical to present new 12-month rheumatoid arthritis data at ACR 2025 ahead of U.S. launch

SetPoint Medical, a commercial-stage medtech company developing neuroimmune modulation therapies for autoimmune diseases, will present new 12-month clinical data from its RESET-RA trial at the American College of Rheumatology (ACR) Convergence 2025. The upcoming data presentation is expected to demonstrate sustained efficacy and safety of the FDA-approved SetPoint System, an implantable device for adults with moderate-to-severe rheumatoid arthritis (RA) who have failed biologics or JAK inhibitors.

This anticipated data release marks a critical pre-commercial milestone for SetPoint Medical, which secured FDA approval in July 2025 and raised $140 million in private financing in August to fund its U.S. market rollout. According to the company, the SetPoint System could redefine treatment options for RA patients who currently have limited alternatives beyond lifelong immunosuppressive drug regimens.

The SetPoint System is the first device-based RA therapy of its kind to receive FDA clearance. It delivers electrical stimulation to the vagus nerve to activate anti-inflammatory pathways, offering a non-pharmaceutical route to disease control. With the ACR presentation imminent, SetPoint Medical aims to solidify its scientific and clinical credibility among rheumatology stakeholders just as it prepares for phased commercial deployment.

What data is SetPoint Medical expected to present at ACR 2025 and why does it matter?

At ACR 2025, SetPoint Medical will present four abstracts spanning clinical efficacy, joint protection, subgroup analysis, and patient preferences. The highlight will be updated 12-month data from the pivotal RESET-RA trial, a double-blind, randomized, sham-controlled study enrolling 242 adults with moderate-to-severe RA. These patients were incomplete responders or intolerant to at least one biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD).

According to previewed results, the treatment group achieved an American College of Rheumatology 20% improvement (ACR20) response rate of 55.8% at 12 months. Disease activity and remission outcomes showed similar positive trends, with nearly half of patients reaching low disease activity by DAS28-CRP or CDAI scores — all without the addition of biologics or JAK inhibitors. Over 97% of patients remained on stimulation therapy through 12 months.

MRI findings are also expected to be a focal point. In patients with erosive RA phenotypes at baseline, those who received the SetPoint System had significantly lower rates of joint erosion progression at three months compared to the control group (18.9% vs 37.8%). This suggests the device may offer not only symptom relief but also structural protection, a goal traditionally reserved for bDMARDs.

These outcomes, if confirmed during the formal presentations, could position the SetPoint System as a true disease-modifying alternative — a significant advancement in RA management.

How are RA patients reacting to the idea of a neuroimmune implant versus current drug therapies?

Another abstract to be presented, focused on patient preference, offers insight into how individuals with RA perceive device-based therapies. A national discrete choice study conducted by SetPoint Medical found that only 32% of RA patients were satisfied with their current treatment regimen. Notably, 45% expressed a positive or highly positive first impression of the SetPoint Therapy approach.

Among biologic-experienced patients, preference skewed in favor of neuroimmune modulation over switching to another biologic or JAK inhibitor. Factors driving these preferences included expectations around improved physical function, fatigue reduction, reduced out-of-pocket costs, and better protection against irreversible joint damage.

This behavioral insight could be crucial for early commercial adoption. Analysts believe the therapy may appeal to a well-defined segment of patients who have exhausted standard treatment options and are actively seeking alternatives with durable benefits and fewer side effects.

What makes the SetPoint System different from traditional RA treatment models?

Unlike conventional pharmacologic therapies that suppress immune responses via cytokine blockade or kinase inhibition, the SetPoint System targets the vagus nerve to naturally activate the body’s inflammation control systems. The therapy is delivered through a small implant in the neck, performed in an outpatient procedure, and offers regular, preset stimulation.

By leveraging bioelectronic modulation, SetPoint Medical is tapping into an emerging therapeutic class often described as “bioelectronic medicine.” For RA, this represents a paradigm shift: from systemic immunosuppression to localized nerve-based modulation.

The RESET-RA trial’s safety profile also underscores this distinction. Serious adverse events related to the implant or stimulation occurred in just 1.7% of patients, and no related deaths or unanticipated complications were observed beyond the perioperative period. These outcomes could prove critical as payers evaluate the therapy’s cost-benefit ratio relative to biologics, which carry both immunologic risks and financial burdens.

How does SetPoint Medical plan to commercialize its implant following FDA approval?

Following FDA approval in July, SetPoint Medical announced a $140 million private financing round in August 2025 to support its commercial roadmap. The Series D was co-led by Elevage Medical Technologies and Ally Bridge Group, with participation from Northwell Health, SPRIG Equity, and returning investors such as Viking Global Investors and Boston Scientific.

This funding is being deployed to scale sales operations, secure reimbursement pathways, and prepare for initial U.S. market entry. To that end, SetPoint Medical has appointed Erik Styacich as Vice President of Sales and Spencer Bailey as Vice President of Market Access and Reimbursement — both of whom bring prior neuromodulation commercialization experience.

The company plans to launch the SetPoint System in select U.S. geographies in late 2025, with broader expansion expected through 2026. Industry analysts believe real-world adoption, reimbursement success, and early physician engagement will be key indicators of whether SetPoint Medical can achieve commercial traction.

How are institutional investors and analysts viewing SetPoint Medical’s positioning?

Investor sentiment has been cautiously optimistic. The combination of FDA approval, robust trial data, and substantial private capital has made SetPoint Medical one of the more closely watched medtech entrants in the autoimmune disease space.

The SetPoint System’s market entry comes at a time when RA treatment costs are under scrutiny, and payers are more willing to explore alternatives that promise cost savings and long-term structural benefits. If early data from ACR 2025 holds up in the real world, it could justify favorable reimbursement positioning and support expansion into other autoimmune indications such as Crohn’s disease and multiple sclerosis.

Analysts suggest that SetPoint Medical is poised to serve as a test case for broader adoption of neuroimmune modulation. Should it succeed in rheumatoid arthritis, the approach may see accelerated uptake in other inflammatory conditions where biologic cycling and treatment fatigue are common challenges.

How could real‑world adoption, payer coverage decisions, and clinician uptake trends shape SetPoint Medical’s commercial trajectory after ACR 2025?

With the unveiling of its data at ACR 2025, SetPoint Medical is entering a critical execution window. Rheumatologists, payers, and institutional backers will be watching closely for market uptake metrics, payer coverage decisions, and any updates on post-approval studies or real-world evidence generation.

In parallel, the company’s ability to scale surgical training, navigate access channels, and educate clinicians on patient selection will shape the therapy’s early footprint. The $140 million financing provides runway, but long-term success will depend on operational performance, patient outcomes, and sustained demand.

For now, the industry awaits ACR 2025 — not just to validate clinical claims, but to see whether SetPoint Medical’s neuroimmune implant is about to disrupt one of chronic medicine’s most entrenched drug categories.

Key takeaways: What does SetPoint Medical’s ACR 2025 data presentation mean for its RA market debut?

• SetPoint Medical will present 12-month clinical data from its pivotal RESET-RA trial at ACR Convergence 2025 on October 26, showcasing sustained efficacy and joint protection from its FDA-approved neuroimmune implant for rheumatoid arthritis.
• The SetPoint System demonstrated a 55.8% ACR20 response rate at 12 months, with nearly half of patients achieving low disease activity or remission without the need for biologic or JAK inhibitor augmentation.
• MRI data showed significant inhibition of joint erosion progression by three months in patients with an erosive phenotype, suggesting structural disease-modifying potential.
• Patient preference studies revealed that biologic-experienced RA patients favored neuroimmune modulation over cycling through additional advanced drug therapies, with key drivers being symptom control, fatigue reduction, and out-of-pocket cost.
• The company is preparing to launch commercially in select U.S. geographies by late 2025, backed by a $140 million private financing round raised in August from Elevage Medical Technologies, Ally Bridge Group, and others.
• Institutional sentiment is cautiously optimistic, with the therapy seen as a potential disruptor in the RA treatment space — but dependent on real-world adoption, payer coverage decisions, and execution of surgical training and market access strategies.