COMPANY
Neuspera Medical
FDA-cleared device company Past trials only
Timeline
- Trial start —: FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics source ↗
- Trial start Not phased (device or behavioral study): Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System source ↗
- Trial start Not phased (device or behavioral study): Post-Approval Study of the Neuspera Sacral Neuromodulation System source ↗
- FDA FDA PMA approval: Neuspera Sacral Neuromodulation System — P240031, Jun 17, 2025. Applicant at approval: Neuspera Medical, Inc. source ↗
- Trial start Not phased (device or behavioral study): Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI) source ↗
- Trial start Phase 1: Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence source ↗
Upcoming milestones
- 2026-10 (ESTIMATED) · · FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics · NCT07383688
- 2026-11 (ESTIMATED) · Not phased · Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System · NCT07247136
- 2029-12 (ESTIMATED) · Not phased · Post-Approval Study of the Neuspera Sacral Neuromodulation System · NCT07144813
Clinical trials (lead sponsor) 5
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07247136 | Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System | Not phased (device or behavioral study) | Recruiting | Nov 19, 2025 | 2026-11 (estimated) |
| NCT07383688 | FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics | Not listed | Not yet recruiting | 2026-03 | 2026-10 (estimated) |
| NCT07144813 | Post-Approval Study of the Neuspera Sacral Neuromodulation System | Not phased (device or behavioral study) | Recruiting | Sep 3, 2025 | 2029-12 (estimated) |
| NCT04232696 | Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI) | Not phased (device or behavioral study) | Active, not recruiting | Dec 13, 2019 | Jul 17, 2024 (actual) |
| NCT03643380 | Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence | Phase 1 | Completed | Aug 17, 2017 | Nov 15, 2017 (actual) |
FDA records (last 2 years)
- FDA PMA approval: Neuspera Sacral Neuromodulation System — P240031, Jun 17, 2025. Applicant at approval: Neuspera Medical, Inc. source ↗
Connect
See your connections at Neuspera Medical on LinkedIn (search by name, results not checked)