HyaLine™ is a homogeneous injectable hydrogel for medical use. It is indicated for deficit of soft tissues and it allows a long lasting correction and a natural look.
HyaLine™ is a suspension of calcium hydroxyapatite microspheres, in a monophasic hyaluronic acid hydrogel.
HyaLine™ is suitable for temporary correction of congenital and acquired soft tissue deficits.
Long lasting effect
HyaLine™ allows a longer duration due to:
- The presence of calcium hydroxyapatite microspheres: Calcium hydroxyapatite is an inorganic compound normally present in bone tissue, which acts as a biostimulator, by stimulating the production of new collagen.
- The high performance and elasticity of the innovative Hyaluronic acid: HyaLine™ is resistant to mechanical stress and it preserves its mechanical properties, while maintaining an easy handling of injection; so it yields a better and longer effect
Medical device CE marked, according to DDM 93/42/EEC, manufactured by EUmaterials Srl.
Lower risk of adverse reactions
The Hyaluronic Acid used to produce HyaLine™ is obtained thanks to a new and better manufacturing process, based on fermentation of the safe and nonpathogenic bacterial strain Bacillus subtilis. The result is a high pure product free of contaminant DNA, proteins and pyrogens, with a decrease of unpredictable adverse reactions.
HyaLine™ is a product whose principal component is hyaluronian in water, containing a defined concentration of calcium hydroxyapatite microspheres. Because of its peculiar composition, HyaLine™ should be used in the subcutaneous layer. Superficial injections should be avoided, because of the presence of calcium hydroxyapatite microspheres. HyaLine™ can be implanted with the classical retrograde sliding technique. A physiological swelling resembling over correction may temporarily occur at the injections site. A revision may be necessary two weeks after the first implantation.
Biological safety and efficacy tests
Both in vitro and in vivo tests, in accordance with the relevant regulations (EN IS O 10993), have demonstrated that HyaLine™ is highly pure and biocompatible, nonmutagenic, non-toxic, non-sensitizing and resistant to mechanical stresses:
- Chemical characterization, including FTIR and NMR spectroscopy
- Mechanical characterization (rheology and texture analysis)
- In vitro cytotoxicity
- In vivo implantation test
- Intracutaneous reactivity test
- Acute systemic toxicity test
- Delayed hypersensitivity test
- Bacterial reverse mutation assay (Ames test)
- In vitro Mammalian Chromosome Aberration Test
- Degradation test
Hyaluronic Acid Concentrations and Indications
|HyaLine™||26 mg/ml||correction of nasolabial fold and cheek defects|
|HyaLine™ ULTRA||24 mg/ml||suborbital-area's correction|
|HyaLine™ PLUS||28 mg/ml||correction of severe nasolabial fold, cheek and chin's defects|