COMPANY
Polarean Imaging
FDA-approved therapeutic company FDA-cleared device company Past trials only
Timeline
- FDA FDA New indication / efficacy supplement: XENOVIEW (xenon xe-129 hyperpolarized) — NDA214375/1, May 30, 2025. Applicant at approval: Polarean Inc. source ↗
- FDA FDA 510(k) clearance: XENOVIEW 3.0T Chest Coil — K243316, Nov 19, 2024. Applicant at approval: Polarean, Inc. source ↗
- Trial start Phase 1: Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging source ↗
- Trial start Phase 3: Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection source ↗
- Trial start Phase 3: Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Transplant source ↗
Clinical trials (lead sponsor) 3
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06271408 | Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging | Phase 1 | Unknown status (ClinicalTrials.gov) | 2024-02 | 2024-04 (estimated) |
| NCT03417687 | Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection | Phase 3 | Completed | Aug 17, 2018 | Oct 31, 2019 (actual) |
| NCT03418090 | Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Transplant | Phase 3 | Completed | Aug 17, 2018 | Nov 4, 2019 (actual) |
FDA records (last 2 years)
NIH awards 4
- NIH award 5R44HL123299-04 FY2019: $979,115 awarded for that fiscal year; activity R44 (SBIR); PI EMAMI, KIARASH; recipient as written: POLAREAN, INC., DURHAM, NC. A Phase III Trial to Validate HP 129Xe MRI as a Funct source ↗
- NIH award 5R44HL123299-03 FY2018: $999,402 awarded for that fiscal year; activity R44 (SBIR); PI EMAMI, KIARASH; recipient as written: POLAREAN, INC., DURHAM, NC. A Phase III Trial to Validate HP 129Xe MRI as a Funct source ↗
- NIH award 2R44HL123299-02A1 FY2017: $999,713 awarded for that fiscal year; activity R44 (SBIR); PI EMAMI, KIARASH; recipient as written: POLAREAN, INC., DURHAM, NC. A Phase III Trial to Validate HP 129Xe MRI as a Fun source ↗
- NIH award 1R43HL123299-01A1 FY2014: $148,476 awarded for that fiscal year; activity R43 (SBIR); PI EMAMI, KIARASH; recipient as written: POLAREAN, INC., DURHAM, NC. Enhanced Optical Module to Enable Polarized 129Xe M source ↗
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