COMPANY
MediBeacon Inc.
FDA-cleared device company Clinical Phase 3
MediBeacon is a medical technology company focused on fluorescent tracer agents and transdermal detection technology to measure organ function. From company website Source · checked 2026-10-19
Sources for this description (1)
- MediBeacon is a medical technology company focused on fluorescent tracer agents and transdermal detection technology to measure organ function.
- “MediBeacon is a medical technology company focused on advancing fluorescent tracer agents and transdermal detection technology to provide vital and actionable measurement of organ function.” https://www.medibeacon.com/company/history/ (2026-10-19)
Timeline
- Trial start Not phased (device or behavioral study): Evaluation of Protein Loading on Measurement of Renal Reserve source ↗
- Trial start Not phased (device or behavioral study): MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure source ↗
- Trial start Phase 1: Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries source ↗
- Trial start Early phase 1: Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium source ↗
- FDA FDA PMA approval: MediBeacon® Transdermal GFR Measurement System (TGFR) — P230019, Jan 17, 2025. Applicant at approval: Medibeacon, Inc. source ↗
- Trial start Phase 3: Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring source ↗
- Trial start Phase 3: Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects source ↗
- Trial start Early phase 1: Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability source ↗
- Trial start Not phased (device or behavioral study): Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System source ↗
- Trial start Phase 2: Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types source ↗
- Trial start Phase 1: Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers source ↗
- Trial start Phase 1: Pharmacokinetics of MP-3180 in Healthy Volunteers source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Phase 1 · Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries · NCT07080008
- 2026-12 (ESTIMATED) · Early phase 1 · Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium · NCT04008121
- 2027-01 (ESTIMATED) · Not phased · Evaluation of Protein Loading on Measurement of Renal Reserve · NCT07335614
- 2027-01 (ESTIMATED) · Not phased · MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure · NCT07349797
Clinical trials (lead sponsor) 11
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07335614 | Evaluation of Protein Loading on Measurement of Renal Reserve | Not phased (device or behavioral study) | Not yet recruiting | 2026-09 | 2027-01 (estimated) |
| NCT07349797 | MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure | Not phased (device or behavioral study) | Recruiting | Aug 10, 2026 | 2027-01 (estimated) |
| NCT07080008 | Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries | Phase 1 | Active, not recruiting | Jan 30, 2026 | 2026-12 (estimated) |
| NCT04008121 | Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium | Early phase 1 | Recruiting | Nov 6, 2025 | 2026-12 (estimated) |
| NCT05777174 | Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring | Phase 3 | Completed | Mar 20, 2023 | Apr 15, 2024 (actual) |
| NCT05425719 | Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects | Phase 3 | Completed | Jun 14, 2022 | Feb 15, 2023 (actual) |
| NCT02772276 | Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types | Phase 2 | Completed | May 11, 2016 | Aug 4, 2021 (actual) |
| NCT03962998 | Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability | Early phase 1 | Completed | Oct 27, 2019 | Oct 5, 2021 (actual) |
| NCT03810833 | Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System | Not phased (device or behavioral study) | Completed | Sep 16, 2019 | Sep 23, 2019 (actual) |
| NCT02098187 | Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers | Phase 1 | Completed | 2014-03 | 2014-03 (actual) |
| NCT02098174 | Pharmacokinetics of MP-3180 in Healthy Volunteers | Phase 1 | Completed | 2013-11 | 2014-01 (actual) |
FDA records (last 2 years)
- FDA PMA approval: MediBeacon® Transdermal GFR Measurement System (TGFR) — P230019, Jan 17, 2025. Applicant at approval: Medibeacon, Inc. source ↗
Connect
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