COMPANY
Spark Biomedical, Inc.
Timeline
- Trial start Not phased (device or behavioral study): Delivering tAN to Reduce HMB: The LUNA Study source ↗
- Trial start Not phased (device or behavioral study): tAN for Substance Use Disorder source ↗
- Grant Government grant: $305,000 (total, as published), announced Oct 20, 2025. Source: company release on GlobeNewswire. source ↗
- Trial start Not phased (device or behavioral study): tAN for First Responders source ↗
- Grant Government grant — STTR: $305,545 (annual award, as published), announced Aug 26, 2025. Agency: NIH/NIAAA. Source: government award database. source ↗
- FDA FDA 510(k) clearance: Sparrow Ascent — K251246, Aug 25, 2025. Applicant at approval: Spark Biomedical, Inc. source ↗
- Raise Private equity round — Series A: $15M (total, as published), announced Apr 30, 2025. Source: company release on GlobeNewswire. source ↗
- Trial start —: Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder source ↗
- Trial start Not phased (device or behavioral study): Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial source ↗
- Trial start Not phased (device or behavioral study): Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction source ↗
- Trial start Not phased (device or behavioral study): Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects source ↗
- Trial start —: Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study source ↗
- Trial start Not phased (device or behavioral study): Neurostimulation to Improve NOWS Outcomes source ↗
- Trial start Not phased (device or behavioral study): Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder source ↗
- Trial start Not phased (device or behavioral study): Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal source ↗
- Trial start Not phased (device or behavioral study): tAN to Mitigate Withdrawal Behaviors in Neonates source ↗
- Trial start Not phased (device or behavioral study): Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal source ↗
Upcoming milestones
- Mar 31, 2027 (ESTIMATED) · · Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder · NCT06487533
- Aug 31, 2027 (ESTIMATED) · Not phased · tAN for Substance Use Disorder · NCT07281261
- Aug 31, 2027 (ESTIMATED) · Not phased · Delivering tAN to Reduce HMB: The LUNA Study · NCT07326722
Funding
- Private equity round — Series A: $15M (total, as published), announced Apr 30, 2025. Source: company release on GlobeNewswire. source ↗
- Government grant: $305,000 (total, as published), announced Oct 20, 2025. Source: company release on GlobeNewswire. source ↗
- Government grant — STTR: $305,545 (annual award, as published), announced Aug 26, 2025. Agency: NIH/NIAAA. Source: government award database. source ↗
Clinical trials (lead sponsor) 13
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07109349 | tAN for First Responders | Not phased (device or behavioral study) | Completed | Sep 10, 2025 | Aug 6, 2026 (actual) |
| NCT06487533 | Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder | Not listed | Recruiting | Feb 19, 2025 | Mar 31, 2027 (estimated) |
| NCT07281261 | tAN for Substance Use Disorder | Not phased (device or behavioral study) | Recruiting | Jan 28, 2026 | Aug 31, 2027 (estimated) |
| NCT07326722 | Delivering tAN to Reduce HMB: The LUNA Study | Not phased (device or behavioral study) | Recruiting | Mar 6, 2026 | Aug 31, 2027 (estimated) |
| NCT05129020 | Neurostimulation to Improve NOWS Outcomes | Not phased (device or behavioral study) | Active, not recruiting | Jul 27, 2022 | Jan 31, 2025 (actual) |
| NCT06814028 | Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial | Not phased (device or behavioral study) | Completed | Feb 14, 2025 | Sep 24, 2025 (actual) |
| NCT06390267 | Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction | Not phased (device or behavioral study) | Completed | Nov 26, 2024 | Jun 18, 2025 (actual) |
| NCT05053503 | Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder | Not phased (device or behavioral study) | Completed | May 27, 2022 | Apr 4, 2025 (actual) |
| NCT05591703 | Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study | Not listed | Completed | Nov 21, 2022 | Jan 31, 2025 (actual) |
| NCT05977946 | Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects | Not phased (device or behavioral study) | Completed | Oct 31, 2023 | Aug 6, 2024 (actual) |
| NCT04588519 | tAN to Mitigate Withdrawal Behaviors in Neonates | Not phased (device or behavioral study) | Completed | May 30, 2020 | Dec 1, 2020 (actual) |
| NCT04731935 | Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal | Not phased (device or behavioral study) | Completed | Mar 18, 2021 | May 26, 2021 (actual) |
| NCT04075214 | Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal | Not phased (device or behavioral study) | Completed | Nov 19, 2019 | Dec 14, 2020 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: Sparrow Ascent — K251246, Aug 25, 2025. Applicant at approval: Spark Biomedical, Inc. source ↗
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