SetPoint Medical
SetPoint Medical is a Valencia, California-based medical device company that developed the first FDA-approved vagus nerve stimulation device for rheumatoid arthritis. It sells the SetPoint System, a miniaturized implantable neurostimulator that activates innate anti-inflammatory pathways to treat biologic-experienced RA patients.
- Company typePrivate
- Founded2007
- HeadquartersValencia, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What SetPoint Medical does
SetPoint Medical is a Valencia, California-based medical device company founded in 2007 that has developed the SetPoint System, the first and only FDA-approved neuroimmune modulation device for the treatment of rheumatoid arthritis. The company was founded on Dr. Kevin Tracey's pioneering research demonstrating that vagus nerve stimulation activates the cholinergic anti-inflammatory pathway, and over nearly two decades translated that science into a miniaturized, leadless, rechargeable implantable neurostimulator placed directly on the left vagus nerve. The device automatically delivers one minute of therapy daily for up to 10 years, reducing proinflammatory cytokines (TNF, IL-6, IL-1β) by 30-70% through activation of innate anti-inflammatory pathways without suppressing the immune system. The pivotal RESET-RA trial enrolled 242 patients and demonstrated 98% therapy persistence at 12 months, 49.3% achieving DAS28-CRP low disease activity or remission, and a 50% relative reduction in joint erosion progression.
SetPoint Medical generates revenue through one-time hardware sales of the SetPoint System implant plus the surgical procedure, with reimbursement supported by a dedicated HCPCS code C1607 and CMS Transitional Pass-Through payment status effective January 2026. The company employs a direct field sales model using Territory Managers who build referral pathways between prescribing rheumatologists and implanting functional neurosurgeons, supplemented by SetPoint Activators who support patients through prior authorization and onboarding. Commercial launch in the U.S. is targeting biologic-experienced RA patients as the primary indication, with named early-adopter centers including Northwell Health, Rush University Medical Center, Ascension Dell Seton Medical Center, and St. John's Regional Medical Center. The company has also initiated a pilot study in relapsing-remitting multiple sclerosis supported by FDA Breakthrough Device Designation, representing a platform expansion into additional autoimmune indications.
The company has raised approximately $140M in its most recent 2025 financing (including $25M Series C and $115M Series D) co-led by Elevage Medical Technologies and Ally Bridge Group, with strategic participation from Abbott, Boston Scientific, Northwell Health, and a syndicate of venture investors. Total capital raised across all funding rounds exceeds $400M including debt. The leadership team combines commercial experience from prior medtech IPOs (Evolus, Intersect ENT, Cutera) with deep neuromodulation expertise (Abbott, Medtronic, Inspire Medical, MicroTransponder), positioning the company for commercial execution following its July 2025 FDA approval.
SetPoint Medical firmographics
Firmographics- Name
- SetPoint Medical
- Legal name
- SetPoint Medical Corporation
- Website
- https://setpointmedical.com
- Company type
- Private
- Founded year
- 2007
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- SetPoint Medical is a Valencia, California-based medical device company that developed the first FDA-approved vagus nerve stimulation device for rheumatoid arthritis. It sells the SetPoint System, a miniaturized implantable neurostimulator that activates innate anti-inflammatory pathways to treat biologic-experienced RA patients.
- Ownership category
- akta.pro rank
SetPoint Medical industry classification
Industry- Product category
- Implantable Bioelectronic Neurostimulators
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)
- akta.pro secondary industries
- General Neurology (HLAKAIAA), Multiple Sclerosis & Neuroimmunology (HLAKAIAF)
Keywords
Where SetPoint Medical is headquartered
LocationHeadquarters
- HQ city
- Valencia
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
SetPoint Medical business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations
Revenue model
- SetPoint System Implant Device Sales: The SetPoint System is sold as an implantable medical device. The one-time procedure includes device placement with upfront costs for the implant and surgical procedure. The device is designed to provide therapy for up to 10 years, representing a long-term treatment relationship with patients. Revenue is generated from device sales to healthcare facilities and providers.
- Healthcare Procedure Reimbursement: SetPoint Medical generates revenue through healthcare procedure reimbursement. CMS granted Transitional Pass-Through (TPT) payment status effective January 1, 2026, creating new HCPCS device category C1607. Commercial insurance, Medicare, and Medicaid may cover SetPoint System on a case-by-case basis with prior authorization.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Multi-year contract | SetPoint System - Implant and Procedure |
| Unit Pricing | Multi-year contract | External Components (Charger, Docking Station) |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels5 records
SetPoint Medical product offering
Product offeringCore offering
SetPoint Medical develops, manufactures, and commercializes the SetPoint System, an FDA-approved implantable neurostimulator placed on the left vagus nerve that automatically delivers one minute of daily therapy for up to 10 years to treat moderately to severely active rheumatoid arthritis in adults with inadequate response or intolerance to biologics or JAK inhibitors. The company also advances investigational neuroimmune modulation applications for multiple sclerosis and Crohn's disease.
Product overview
SetPoint Medical offers the SetPoint System, an FDA-approved neuroimmune modulation therapy platform for rheumatoid arthritis. The core product consists of the SetPoint System - a miniaturized implantable neurostimulator placed on the vagus nerve that delivers one-minute daily electrical stimulation to activate innate anti-inflammatory pathways. The system includes the implantable device, wireless charger, docking station, and supporting components. The company is also advancing pipeline applications for multiple sclerosis and Crohn's disease.
Differentiator
Problem solved
Functional benefit
Brands
- SetPoint System: FDA-approved neuroimmune modulation device for treating rheumatoid arthritis through vagus nerve stimulation
- SetPoint Therapy
- RESET-RA
Products and services
- SetPoint System FDA-approved neuroimmune modulation device consisting of a small, wireless, rechargeable, integrated neurostimulator enclosed in a ceramic and titanium case that is placed directly on the left vagus nerve to deliver precise electrical pulses for treatment of rheumatoid arthritis. The system includes the implantable device, wireless charger, docking station, and therapy management cards, and is indicated for adults with moderately to severely active RA who have had inadequate response or intolerance to biologics or JAK inhibitors.
- SetPoint Implant The implantable component of the SetPoint System - a small, leadless, integrated neurostimulator placed on the left vagus nerve within a flexible silicone Pod that automatically delivers therapy for one minute each day for up to 10 years. Features a rechargeable battery and integrated telemetry.
- SetPoint Charger Wireless neck-worn charger used to recharge the SetPoint Implant for a few minutes each week. Includes docking station for storage and carrying case for travel. Designed to last up to 5 years and replaceable by the rheumatologist as needed.
- SetPoint Docking Station Charging station for the SetPoint Charger, designed to keep the charger fully charged when not in use. Part of the external component system for the SetPoint Implant.
Quantifiable outcome
- 98% of patients remained on SetPoint Therapy through 12 months in RESET-RA study
- +5 more outcomes
Companies that use SetPoint Medical
Customer profileNamed customers6 records
Segments3 records
Ideal customer profiles2 records
SetPoint Medical technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
SetPoint Medical partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered major.
- Shepherd Center's Andrew C. Carlos MS InstitutemajorClinical study site for pilot clinical study evaluating SetPoint System for relapsing-remitting multiple sclerosis. Dr. Jacqueline Rosenthal serves as principal investigator. First patients enrolled in April 2026.
- UW Medicine Multiple Sclerosis Center (Seattle)majorClinical study site for pilot clinical study evaluating SetPoint System for relapsing-remitting multiple sclerosis.
- Minnesota Center for Multiple SclerosismajorClinical study site for pilot clinical study evaluating SetPoint System for relapsing-remitting multiple sclerosis. Part of multicenter randomized sham-controlled double-blind study enrolling up to 60 patients.
- Johns Hopkins UniversitymajorClinical study site for pilot clinical study evaluating SetPoint System for relapsing-remitting multiple sclerosis.
- West Virginia UniversitymajorClinical study site for pilot clinical study evaluating SetPoint System for relapsing-remitting multiple sclerosis.
- UT Medicine Multiple Sclerosis and Neuroimmunology Center (Austin)majorClinical study site for pilot clinical study evaluating SetPoint System for relapsing-remitting multiple sclerosis.
- University of Texas Health Science Center (Houston)majorClinical study site for pilot clinical study evaluating SetPoint System for relapsing-remitting multiple sclerosis.
Scale indicators9 records
Recent moves6 records
Expansion highlights6 records
SetPoint Medical competitors and assessment
Company assessmentDirect peers
- MicroTransponder: MicroTransponder is a closely comparable privately-held neurostimulation company developing implantable vagus nerve stimulation therapy, most notably for post-stroke recovery and other chronic conditions. Like SetPoint, it is pursuing FDA-approved VNS-based therapeutics for chronic diseases, operates at similar scale, and shares the SetPoint VP of Market Access (Spencer Bailey came from MicroTransponder). Direct overlap in implantable VNS mechanism and indication-expansion strategy.
- electroCore: electroCore develops non-invasive vagus nerve stimulation (nVNS) therapy, including FDA-cleared gammaCore for migraine and cluster headache. It is the most direct VNS-mechanism competitor to SetPoint, pursuing vagus nerve stimulation as a platform across multiple indications, though its non-invasive delivery differs from SetPoint's implantable approach.
- Inspire Medical Systems: Inspire Medical Systems is a commercial-stage implantable neurostimulation company (hypoglossal nerve stimulation for obstructive sleep apnea) with a similar profile to SetPoint: FDA-approved Class III implantable device, US-focused direct-to-physician sales model, and successful execution from startup to commercial scale and IPO. Closely analogous business model and go-to-market motion.
- CVRx: CVRx is a commercial-stage company developing Barostim, an implantable neuromodulation device for heart failure and resistant hypertension. Comparable to SetPoint in being a venture-backed, FDA-approved implantable neuromodulation company pursuing chronic disease indications with similar regulatory and commercialization pathways.
- Axonics Modulation Technologies: Axonics develops and commercializes implantable sacral neuromodulation systems for incontinence and overactive bladder. It shares SetPoint's profile as a venture-backed, FDA-approved implantable neuromodulation company with miniaturized rechargeable technology, a similar commercial launch trajectory, and overlap in venture investors (e.g., some of the same healthcare-focused funds).
Broad incumbents
- LivaNova: LivaNova (formerly Cyberonics) is the established market leader in implantable vagus nerve stimulation, with its VNS Therapy system FDA-approved for drug-resistant epilepsy and treatment-resistant depression. It pioneered the implantable VNS category SetPoint operates in and represents the most relevant scaled implantable-VNS comparable, though its indications are neurology rather than autoimmune.
- Nevro Corp: Nevro is a commercial-stage neuromodulation company with its Senza spinal cord stimulation system for chronic pain, a publicly-traded scaled neuromodulation player. Relevant as a comparable implantable neurostim business model, though its indication (chronic pain) and mechanism (spinal cord stimulation) differ from SetPoint's vagus nerve approach.
- Medtronic: Medtronic is a global medical device leader with a broad neuromodulation portfolio including VNS, spinal cord stimulation, and deep brain stimulation, and is a historical SetPoint investor. Represents the large incumbent competitive and potential strategic-acquirer reference point for implantable neurostimulation markets.
- Abbott: Abbott operates a major neuromodulation franchise (Proclaim DRG, Proclaim Infinity, Infinity OCTRODE) and is a SetPoint investor. Comparable as a broad incumbent neuromodulation platform with the strategic optionality to acquire SetPoint's neuroimmune platform as an adjacency to its existing pain and movement disorder franchises.
Emerging players
- Galvani Bioelectronics: Galvani Bioelectronics is a joint venture between GlaxoSmithKline and Verily (Alphabet) developing bioelectronic medicines that use implantable devices to modulate neural signals for chronic diseases, including autoimmune indications. Conceptually the closest large-scale strategic peer to SetPoint's neuroimmune modulation thesis, with substantially greater resources but earlier-stage clinical pipeline.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
SetPoint Medical social profiles
Digital presenceSetPoint Medical financial estimates
Financial estimateRevenue estimate
Valuation estimate
SetPoint Medical leadership team
Management profileNumber of profiles
Profiles19 records
SetPoint Medical funding detail
Funding detailFunding overview
Funding rounds15 records
Investors33 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SetPoint Medical M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SetPoint Medical
What does SetPoint Medical do?
SetPoint Medical develops, manufactures, and commercializes the SetPoint System, an FDA-approved implantable neurostimulator placed on the left vagus nerve that automatically delivers one minute of daily therapy for up to 10 years to treat moderately to severely active rheumatoid arthritis in adults with inadequate response or intolerance to biologics or JAK inhibitors. The company also advances investigational neuroimmune modulation applications for multiple sclerosis and Crohn's disease.
Is SetPoint Medical a public or private company?
SetPoint Medical is a private company. It is classified as venture growth investor backed and is currently operating.
When was SetPoint Medical founded?
SetPoint Medical was founded in 2007. It employs 51 to 100 people.
Where is SetPoint Medical based?
SetPoint Medical is headquartered in Valencia, United States, in the North America region.
How does SetPoint Medical make money?
Two revenue lines are on record. SetPoint System Implant Device Sales are the primary driver. The others are healthcare Procedure Reimbursement.
Who are SetPoint Medical's main competitors?
Direct peers on record are MicroTransponder, electroCore, Inspire Medical Systems, CVRx and Axonics Modulation Technologies. Broad incumbents are LivaNova, Nevro Corp, Medtronic and Abbott. Galvani Bioelectronics is listed as an emerging player.
Does SetPoint Medical have an API?
No public API is recorded for SetPoint Medical.
What industry is SetPoint Medical in?
SetPoint Medical's product category is Implantable Bioelectronic Neurostimulators. Its primary akta.pro industry code is HLAHAEAK, Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS), with a secondary code of HLAKAIAA, General Neurology. Its NAICS code is 5417 and its SIC code is 3841.