HYALINE is a suspension of calcium hydroxyapatite microspheres, in a monophasic hyaluronic acid hydrogel derived from Bacillus subtilis, resistant to mechanical stress and preservative its mechanical properties.
Calcium hydroxyapatite is an inorganic compound normally present in bone tissue, which acts as a biostimulator, by stimulating the production of new collagen.
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Hyaline - Scientech Corporation Sagl
1. 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
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.
EUmaterials S.R.L.
SS 7 Km 7+300, Cittadella della Ricerca
72100 Brindisi, Italy
2. hyalinetm
features hyalinetm
Advantages
Monophasic hyaluronic acid hydrogel
derived from human nonpathogenic bacteria
High performance and elasticity
Low 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 tests
Both 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 technique
HyaLine™ 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