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Biocompatibles Drug-Eluting Bead technology is supported by a comprehensive programme of clinical trials designed to confirm our products' superior clinical benefits. Current pre-clinical and clinical trials evidence benefits in terms of efficacy, survival, tolerability and safety in a number of cancers. Future developments in Drug-Eluting Bead technology targets new therapeutic areas where biological drug delivery or biodegradability is required or advantageous.
PRECISION BeadPRECISION Bead is a Drug-Eluting bead loaded with doxorubicin, available for sale in Hong Kong and in submission for CE mark review.
PARAGON BeadPARAGON Bead is a Drug-Eluting Bead loaded with irinotecan and has entered clinical evaluation. It is intended for the treatment of liver metastases of the colon.
Cell BeadCell Bead is a bead in development for the encapsulation of cells or tissues for long term biologic drug delivery.
Biodegradable BeadBiodegradable Bead is a bead being developed to offer delivery solutions where biodegradability of the bead is a requirement or an advantage.
| Trial Name | Location | Objective | Indication | Status | Patient No. |
|---|---|---|---|---|---|
| PRECISION I | Barcelona | Safety, Dose | HCC | Journal of Hepatology 46 (3): 474-481; March 2007 | 20 |
| PRECISION II | Hong Kong | Safety, Dose | HCC | Clin. Gastroenterology & Hepatology 2007, 5: 1100-1108 | 35 |
| PRECISION IV | Multi-Centre US | Randomised Control Trial: Survival | HCC | FDA approved. Not started recruiting | 400 |
| PRECISION V | Multi-Centre Europe | Randomised Control Trial: Safety & Efficacy | HCC | Study completed, data first presented at CIRSE 2008 | 212 |
| PRECISION Athens | Greece | Safety, Efficacy | HCC | Euro Oncologic Dis. 07 Issue 1, CVIR. Online 208: 31 (2) | 60 |
| PRECISION Baltimore | US | Safety, Efficacy | HCC | Recruitment complete | 20 |
| PRECISION eRFA | Pisa, Italy | Safety, Efficacy | HCC | Journal of Hepatology 49 (2) 217-222; August 2008 | 20 |
| PRECISION Vienna | Austria | Safety, Efficacy & Technique | HCC | CardioVascular and Interventional Radiology 31 (3) 468-476; May 2008 | 28 |
| PRECISION Bologna | Italy | Randomised Control Trial: Survival | HCC | 91 patients treated | 214 |
| PRECISION IGR | Paris | Safety, Efficacy | Neuroendocrine metastases | Journal of Vascular and Interventional Radiology 19 (6) 855-861; June 2008 | 20 |
| Trial Name | Location | Objective | Indication | Status | Patient No. |
|---|---|---|---|---|---|
| PARAGON I | US | Safety, Efficacy | mCRC | Study initiated | 70 |
| PARAGON Ferrara | Italy | Safety, Efficacy & Technique | mCRC | Anticancer Research 26: 3793-3796 (2006) | 25 |
| PARAGON II | UK, France & Spain | Safety, Efficacy | mCRC | Study initiated | 20 |
| Trial Name | Location | Objective | Indication | Status | Patient No. |
|---|---|---|---|---|---|
| OPEN REGISTRY | Kentucky, US | Safety, Efficacy | Primary and Metastatic Liver Cancer | 291 patients recruited | 350 |
| CellBead Neuro | Hannover | Safety | Stroke | Trial approved | 20 |
The products may not be available for sale, may not be registered, approved or cleared for use as claimed, in all countries where Biocompatibles is represented.
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