Established safety profile for Ellansé®
Product components with a long safety history
Perfectly Smooth
SEM Picture
Smooth Microspheres
Light Microscopy Picture
Light Microscopy: Histology 2-weeks post intradermal injection
The unique smooth and spherical shape of ELLANSÉ® microspheres
- Is the basis for optimal biocompatibility as rough surfaces and irregular shaped microspheres have the propensity to induce adverse events, such as nodules, and result in decreased collagen deposition 16-20
- Provide a long-lasting and high quality tissue scaffold
SHORT-TERM SAFETY
Pre-clinical Data7
- 2-weeks implantation data clearly show the particles well-embedded in a healthy tissue environment and demonstrate excellent local tolerance
LONG-TERM SAFETY
Scientific Evidence and Literature10, 13
- Long-term bioresorption of Ellanse components through the normal metabolic pathways is well documented.
- PCL microspheres bioresorption demonstrated via radio-labeled bioresorption studies
- In-house in-vitro resorption study of ELLANSÉ® range PCL microspheres is consistent with published literature data
High Patient Satisfaction10
Patient Satisfaction with ELLANSÉ® Treatment (mean) using VAS
| Patient Satisfaction | ELLANSÉ® S 12 Months | ELLANSÉ® M 24 Months |
| Satisfaction | 74% | 81.7% |
At 24 months post-injection
-
of patients like to repeat ELLANSÉ® – S treatment
-
of patients like to repeat ELLANSÉ® – M treatment
Proven Efficacy & Safety Profile10
High efficacy of ELLANSÉ® – S and ELLANSÉ® – M in nasolabial folds treatment with a good safety profile over a 2 year period10 Investigator Evaluated Aesthetic Global Improvement Scale GAIS
Of patients with at least improvedresults at 12 months10
Of patients with at least improved results at 24 months10
Comparative clinical study of ELLANSÉ® vs a NASHA hyaluronic acid for treatment of nasolabial folds15
ELLANSÉ® offers clear advantages over the NASHA based dermal filler, both in terms of durability and efficiency15
