COMPANY
Synapse Biomedical
Timeline
- FDA FDA 510(k) clearance: Synchrony (20-3000) — K242704, Jun 5, 2025. Applicant at approval: Synapse Biomedical, Inc. source ↗
- Trial start Not phased (device or behavioral study): Study of TransAeris® System for Enhanced Recovery After Surgery in France source ↗
- Trial start Not phased (device or behavioral study): Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation source ↗
- Trial start Not phased (device or behavioral study): Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation source ↗
- Trial start Not phased (device or behavioral study): NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS) source ↗
- Trial start Not phased (device or behavioral study): Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation source ↗
- Trial start Not phased (device or behavioral study): Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures source ↗
- Trial start Not phased (device or behavioral study): Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation source ↗
- Trial start Not phased (device or behavioral study): Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis source ↗
- Trial start Not phased (device or behavioral study): Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS) source ↗
- Trial start Not phased (device or behavioral study): Electrical Activation of The Diaphragm for Ventilatory Assist source ↗
Clinical trials (lead sponsor) 10
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05404477 | Study of TransAeris® System for Enhanced Recovery After Surgery in France | Not phased (device or behavioral study) | Completed | Jun 22, 2022 | Jul 13, 2023 (actual) |
| NCT04899856 | Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Aug 10, 2021 | 2024-05 (estimated) |
| NCT02410798 | Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures | Not phased (device or behavioral study) | Completed | 2015-05 | 2015-08 (actual) |
| NCT04309123 | Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation | Not phased (device or behavioral study) | Completed | Mar 30, 2020 | Mar 31, 2021 (actual) |
| NCT00010374 | Electrical Activation of The Diaphragm for Ventilatory Assist | Not phased (device or behavioral study) | Completed | 2000-02 | 2008-10 (actual) |
| NCT04457427 | Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation | Not phased (device or behavioral study) | Withdrawn | 2016-12 | 2022-03 (estimated) |
| NCT01605006 | Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis | Not phased (device or behavioral study) | Completed | 2012-07 | 2017-02 (actual) |
| NCT03034317 | NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS) | Not phased (device or behavioral study) | Withdrawn | Feb 2, 2017 | Feb 8, 2018 (actual) |
| NCT02411383 | Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation | Not phased (device or behavioral study) | Completed | 2015-02 | 2016-04 (actual) |
| NCT00420719 | Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS) | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | 2004-10 | 2009-10 (estimated) |
FDA records (last 2 years)
- FDA 510(k) clearance: Synchrony (20-3000) — K242704, Jun 5, 2025. Applicant at approval: Synapse Biomedical, Inc. source ↗
NIH awards 3
- NIH award 1R43NS057845-01A1 FY2007: $124,553 awarded for that fiscal year; activity R43 (SBIR); PI IGNAGNI, ANTHONY R; recipient as written: SYNAPSE BIOMEDICAL, INC., OBERLIN, OH. Development of Natural Orifice Trans source ↗
- NIH award 1R43NS052993-01A1 FY2006: $142,827 awarded for that fiscal year; activity R43 (SBIR); PI IGNAGNI, ANTHONY R; recipient as written: SYNAPSE BIOMEDICAL, INC., OBERLIN, OH. Binder Free Diaphragm Pacing Stimula source ↗
- NIH award 1R41HL078195-01 FY2004: $99,895 awarded for that fiscal year; activity R41 (STTR); PI DIMARCO, ANTHONY F.; recipient as written: SYNAPSE BIOMEDICAL, INC., OBERLIN, OH. Combined Intercostal and Diaphragm Pac source ↗