COMPANY
Biocomposites
FDA-cleared device company Clinical Phase 2
Timeline
- Trial start Not phased (device or behavioral study): Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin. source ↗
- Trial start II: A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. source ↗
- Trial start Phase 2: A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis source ↗
Upcoming milestones
- Dec 1, 2026 (ESTIMATED) · II · A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. · NCT06283979
- 2027-10 (ESTIMATED) · Not phased · Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin. · NCT07270380
Clinical trials (lead sponsor) 4
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07270380 | Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin. | Not phased (device or behavioral study) | Recruiting | 2026-06 | 2027-10 (estimated) |
| NCT06283979 | A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. | II | Recruiting | Jun 15, 2025 | Dec 1, 2026 (estimated) |
| NCT05539963 | A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis | Phase 2 | Active, not recruiting | Jan 23, 2023 | Jun 20, 2025 (estimated) |
| NCT06808568 | Expanded Access Program (EAP) STIMULAN VG | Not listed | Available | Not listed | Not listed |
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