SetPoint System by SetPoint Medical: status and timeline

SetPoint System

Implantable neurostimulator (vitamin-tablet size) stimulates vagus nerve 60 seconds daily. For moderate-to-severe RA refractory to biologics.

DeployStage 4 of 5

FDA approved Jul 2025. Launching select U.S. markets 2025; nationwide 2026.

Updated 31 Jul 2025Checked 10 Oct0 updates this week

Milestones

Next · Initial market launch in select U.S. centers

RESET-RA trial enrollment completed2023Complete.
RESET-RA topline results announced10 Jul 2024Complete.
FDA Premarket Approval (PMA) granted31 Jul 2025Complete.
Initial market launch in select U.S. centersTarget 2025Current milestone.
National U.S. market expansionTarget 2026Not yet reached.
Initiation of additional autoimmune indication trialsTarget 2026Not yet reached.

Most important updates

Upcoming

2025Initial market launch in select U.S. centers (next)
2026National U.S. market expansion
2026Initiation of additional autoimmune indication trials

Current obstacles

Accepting surgery for a chronic diseaseRA is manageable with daily pills. Convincing patients to undergo surgery needs strong durability data, which is still accumulating.
Variability: 25% cannot eliminate biologicsNo biomarkers predict who will respond. Need better patient selection criteria.
Insurance coverage unclearNovel device pricing and reimbursement pathways not yet established. Uncertainty for patients.

Physics limits

Surgical risk and durabilityImplant carries infection risk and requires anesthesia. Device life 5-10 years means replacement surgery, cumulative risk.
Slow onsetEffect develops over weeks to months, not days like oral drugs. Requires patience.
Not universal replacement25% still need biologics with SetPoint. Does not work for all RA phenotypes.

How it works

4 parts

Implant

Vitamin-tablet device below clavicle

Neurostimulator placed below left collarbone. Single lead attached to left vagus nerve. Similar to pacemaker but smaller.

Daily Pulse

60-second vagal pulse once daily

Device automatically delivers 60-second pulse to vagus nerve each day. Activates vagal afferent pathway, signaling immune system to suppress inflammation.

Immune Suppression

Acetylcholine suppresses pro-inflammatory cytokines

Stimulation triggers acetylcholine release on macrophage nicotinic receptors. Suppresses TNF-alpha and IL-6 cytokines driving RA.

Disease Control

Sustained remission, reduced drug burden

Over weeks, reduced inflammation lets most patients stop or reduce biologics, decreasing side effects and infections.

Spec sheet

Spec	SetPoint System
Neurostimulator dimensions	Approximately 25 mm in length (vitamin tablet size)^R (reported)
Daily stimulation duration	60 seconds^R (reported)
RESET-RA enrollment	242 patients across 41 U.S. sites^R (reported)
ACR20 response at 3 months	35.2% vs 24.2%^R (reported)
Patients off all biologics at 1 year	75%^R (reported)

^R reported by the company

Papers & demos

1 item

Jul 2024paper
RESET-RA topline results: 35.2% ACR20 response with 75% off biologics at 1 year (opens businesswire.com)Primary efficacy endpoint met in 242-patient randomized controlled trial of the SetPoint System for moderate-to-severe rheumatoid arthritis.

Update log

2 updates

Thu 31 Jul 2025

Major: FDA grants Premarket Approval (PMA) for SetPoint System, the first neuroimmune-modulation device for rheumatoid arthritisPressRegulatory

Wed 10 Jul 2024

Major: SetPoint Medical announces positive topline results from RESET-RA trial in 242 patients with moderate-to-severe rheumatoid arthritisPressResearch

About SetPoint Medical

The team behind SetPoint System

SetPoint Medical

Neuroimmune modulation, rheumatoid arthritis

Develops SetPoint System, implantable device stimulating vagus nerve once daily. Activates anti-inflammatory pathway, lets patients reduce biologic drugs. FDA approved July 2025.

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.

setpointmedical.com (opens setpointmedical.com)Company profile →

Founded: 200620 yrs
Headquarters: United States
Status: Private
Valuation: $650MprivateAug 2025
Staff: ~117Mar 2026
Raised: $140M1 round
Last round: Series C and D (combined) · $140MAug 2025
Works in: NeurotechStimulation therapies
Coverage: 1 program · 4 updateslatest 1 Aug 2025checked 10 Oct
Lead investors: Elevage Medical TechnologiesAlly Bridge Group
Investors: Abbott (opens abbott.com)Boston Scientific (opens bostonscientific.com)Northwell Health (opens northwell.edu)
People: Murthy Simhambhatla (opens setpointmedical.com)Chief Executive OfficerAllan Will (opens setpointmedical.com)Chairman

Spec

SetPoint System

Neurostimulator dimensions

Approximately 25 mm in length (vitamin tablet size)^R (reported)

Daily stimulation duration

60 seconds^R (reported)

RESET-RA enrollment

242 patients across 41 U.S. sites^R (reported)

ACR20 response at 3 months

35.2% vs 24.2%^R (reported)

Patients off all biologics at 1 year

75%^R (reported)