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.

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

IndicationsHyaLine™ is suitable for temporary correction of congenital and acquired soft tissue deficits.

Long lasting effectHyaLine™ 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

Lower risk of adverse reactionsThe 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.

EUmaterials S.R.L.SS 7 Km 7+300, Cittadella della Ricerca72100 Brindisi, Italy

HyALiNeTm feATures HyALiNeTm ADvANTAgesmonophasic hyaluronic acid hydrogelderived from human nonpathogenic bacteria

High performance and elasticityLow immunological response risk

Content of calcium hydroxyapatite microspheres which stimulate the production of collagen

Longer duration than pure hyaluronic acid

innovative technology for obtaining hyaluronic acid uses minimal media, no organic solvents and a highly efficient purification process

very pure product

Texture similar to soft deep tissue Natural feeling

Biological safety and efficacy testsBoth in vitro and in vivo tests, in accordance with the relevant regulations (eN isO 10993), have demonstrated that HyaLine™ is highly pure and biocompatible, non-mutagenic, 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

Injection techniqueHyaLine™ is a product whose principal component is hyaluronan in water, containing a defined concentration of calcium hydroxylapatite 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.

Code 100 Rev 00