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.

Composition

HyaLine™ is a suspension of calcium hydroxyapatite microspheres, in a monophasic hyaluronic acid hydrogel.

Indications

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

Certification

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.

Injection technique

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

PRODUCTCONCENTRATIONINDICATIONS
HyaLine™26 mg/mlcorrection of nasolabial fold and cheek defects
HyaLine™ ULTRA24 mg/mlsuborbital-area's correction
HyaLine™ PLUS28 mg/mlcorrection of severe nasolabial fold, cheek and chin's defects

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