The SetPoint System is the first neuroimmune modulation therapy available for people living with rheumatoid arthritis (RA), offering a novel, device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. In March 2024, SetPoint received breakthrough device designation from the FDA for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS). The company is expanding its addressable market beyond RA into other chronic autoimmune conditions.
Cyborg Score Rationale
SetPoint Medical has received FDA approval for its first-in-class SetPoint System, a transformative milestone establishing commercial viability. The company has raised $581M and holds a strong platform expansion strategy with breakthrough device designation for multiple sclerosis that facilitates interactive communication and priority regulatory review. Commercial launch is underway in targeted U.S. cities with expansion expected.
Top Insights
The SetPoint System received FDA approval in July 2025 as a breakthrough innovation for rheumatoid arthritis in adults not adequately managed by existing advanced therapies
March 2024 breakthrough device designation for relapsing-remitting multiple sclerosis enables priority regulatory review and supports reimbursement and patient access
The neuroimmune modulation platform for multiple sclerosis has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot
Major investors include Abbott, Ally Bridge Group, Elevage Medical Technologies, Northwell Health, and Sprig Equity among 29 total investors
Named Competitors
Mainstay Medical — Neuromodulation for chronic pain and spinal conditions
Saluda Medical — Closed-loop neuromodulation technology
Aleva Neurotherapeutics — Neural stimulation for neurological conditions
Salvia BioElectronics — Bioelectronic medicine platform
Recent Developments
(July 2025) FDA approval of SetPoint System for rheumatoid arthritis
(March 2024) Breakthrough device designation for relapsing-remitting multiple sclerosis
(March 2024) Acceptance into FDA's Total Product Life Cycle Advisory Program (TAP) Pilot for MS indication
(Early 2026) Planned expansion of SetPoint System across the country
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