COMPANY
SetPoint Medical
FDA-cleared device company Clinical Phase 3
SetPoint Medical develops the SetPoint System, a small wireless implantable device that stimulates the vagus nerve to reduce inflammation. From company website Source · checked 2026-10-19
Sources for this description (1)
- SetPoint Medical develops the SetPoint System, a small wireless implantable device that stimulates the vagus nerve to reduce inflammation.
- “This device-based therapeutic approach includes a small, wireless, implantable device, the SetPoint System, that stimulates the vagus nerve—activating the body’s innate pathways to reduce inflammation and restore immunologic balance. 1-3” https://setpointmedical.com/ (2026-10-19)
Hiring
| Title | Location (from posting) | Employer posted | First seen |
|---|---|---|---|
| Market Access Specialist (I - II) | Offsite, Remote | Oct 20, 2026 | Oct 12, 2026 |
| Technical Writer (Contract) | SetPoint Medical Valencia Office | Oct 20, 2026 | Oct 12, 2026 |
| CRM Excellence Manager | Offsite | Oct 16, 2026 | Oct 17, 2026 |
| Buyer I | SetPoint Medical Valencia Office | Oct 9, 2026 | Oct 12, 2026 |
| IT Manager | SetPoint Medical Valencia Office | Oct 9, 2026 | Oct 12, 2026 |
Timeline
- Trial start Not phased (device or behavioral study): The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study source ↗
- Trial start —: The SetPoint System Safety & Performance Post-Approval Study source ↗
- Raise Private equity round: $140M (total, as published), announced Aug 11, 2025. Source: company's own press page. source ↗
- FDA FDA PMA approval: SetPoint System — P240039, Jul 30, 2025. Applicant at approval: SetPoint Medical. source ↗
- Trial start Phase 3: Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis source ↗
- Trial start Not phased (device or behavioral study): Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) source ↗
- Trial start Not phased (device or behavioral study): Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) source ↗
- Trial start Phase 1/Phase 2: Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease source ↗
- Trial start Not phased (device or behavioral study): Vagus Nerve Stimulation in Crohn's Disease source ↗
- Trial start Phase 1/Phase 2: Long Term Extension Study For SPM-005 Participants source ↗
- Trial start Not phased (device or behavioral study): Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis source ↗
Upcoming milestones
- Dec 8, 2026 (ESTIMATED) · Not phased · Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) · NCT04862117
- Dec 31, 2027 (ESTIMATED) · Not phased · The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study · NCT06796504
- Jan 1, 2031 (ESTIMATED) · · The SetPoint System Safety & Performance Post-Approval Study · NCT07489326
Funding
- Private equity round: $140M (total, as published), announced Aug 11, 2025. Source: company's own press page. source ↗
Clinical trials (lead sponsor) 9
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04862117 | Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) | Not phased (device or behavioral study) | Active, not recruiting | Jul 28, 2018 | Dec 8, 2026 (estimated) |
| NCT06796504 | The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study | Not phased (device or behavioral study) | Recruiting | Apr 17, 2026 | Dec 31, 2027 (estimated) |
| NCT04539964 | Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis | Phase 3 | Active, not recruiting | Jan 11, 2021 | May 16, 2024 (actual) |
| NCT07489326 | The SetPoint System Safety & Performance Post-Approval Study | Not listed | Not yet recruiting | Apr 15, 2026 | Jan 1, 2031 (estimated) |
| NCT03437473 | Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA) | Not phased (device or behavioral study) | Completed | Mar 6, 2018 | Dec 10, 2018 (actual) |
| NCT02311660 | Vagus Nerve Stimulation in Crohn's Disease | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | 2014-12 | 2017-08 (estimated) |
| NCT02951650 | Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease | Phase 1/Phase 2 | Unknown status (ClinicalTrials.gov) | 2015-01 | 2018-05 (estimated) |
| NCT01552941 | Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid Arthritis | Not phased (device or behavioral study) | Completed | 2011-07 | 2014-03 (actual) |
| NCT01552538 | Long Term Extension Study For SPM-005 Participants | Phase 1/Phase 2 | Unknown status (ClinicalTrials.gov) | 2012-01 | 2018-05 (estimated) |
FDA records (last 2 years)
- FDA PMA approval: SetPoint System — P240039, Jul 30, 2025. Applicant at approval: SetPoint Medical. source ↗
Open jobs 6
| Title | Location (from posting, not HQ) | Employer posted | First seen | Level |
|---|---|---|---|---|
| Market Access Specialist (I - II) | Offsite, Remote | Oct 20, 2026 | Oct 12, 2026 | Not stated |
| Technical Writer (Contract) | SetPoint Medical Valencia Office | Oct 20, 2026 | Oct 12, 2026 | Mid |
| CRM Excellence Manager | Offsite | Oct 16, 2026 | Oct 17, 2026 | Not stated |
| Buyer I | SetPoint Medical Valencia Office | Oct 9, 2026 | Oct 12, 2026 | Entry |
| IT Manager | SetPoint Medical Valencia Office | Oct 9, 2026 | Oct 12, 2026 | Mid |
| Talent Acquisition Manager | SetPoint Medical Valencia Office | Oct 7, 2026 | Oct 12, 2026 | Mid |
Connect
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