REGENFLEX® er et medicinsk produkt baseret på en stærkt oprenset hyaluronsyre med en molekylvægt mellem 800-1.200 kDalton.
Natriumhyaluronat er en grundlæggende komponent i synovialvæsken, for sidstnævntes viskoelastiske egenskaber.
Natriumhyaluronatet indeholdt i REGENFLEX® opnås ved hjælp af gæring, idet man undgår enhver form for kemisk modifikationsbehandling for at garantere et absolut rent produkt, fri for forbliver fremmed for den fysiologiske kontekst af implementeringen.

REGENFLEX® STARTER and REGENFLEX® are injectable products based on a buffered physiological solution (respectively 1,6% and 0,8%) of hyaluronic acid sodium salt with significant viscoelastic properties.

The packages include one single-use syringe, containing 2ml of sterile apyrogen solution.

Regenflex BIO-PLUS is a transparent gel based on cross-linked and linear intercalated Hyaluronic acid, created with an advanced and patented technological process.

The aim of this intra-articular injectable is to prevent or to reduce pain, restoring the normal damping and lubricating function of the joint.
Not only will the joint function improve, but the patient will also experience an improvement in their quality of life.

 

Manufacturing technology and functioning
The manufacturing technology used to produce Regenflex BIO-PLUS is the one used for BIORIVOLUMETRIA. The Biorivolumetria products are MONO-PHASE GELS obtained through a long-lasting cross-linking process at low temperature, the “gentle cross-linking”. The slow mixing allows for the cross-linking agent (BDDE) to widespread in a better and more uniform way. The amount of BDDE used is 30 per cent lower than in the majority of other products with equal degree of viscosity currently on the market. For the manufacturing of Regenflex BIO-PLUS three molecular weights of Hyaluronic Acid are used: 1 M, 2 M and 500 THOUSAND Dalton. The latter is linear and intercalated and represent 10 per cent of the total Hyaluronic Acid. Differently long chains of HA help to better calibrate the product’s viscosity. The linear Hyaluronic Acid is released gradually in time, performing a prolonged biological action (visco-induction).

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The matter of weight: 2 molecular fractions

The action of the Hyaluronic acid depends on its molecular weight. The weight, in fact, influences the quantity of exogenous hyaluronic acid that can penetrate the synovial membrane: such quantity is proportionally inverse to the molecular weight itself. The close combination of the cross-linked and the intercalated linear Hyaluronic acid, makes it possible to inject two molecular fractions:

Regenflex BIO-PLUS & Biorivolumetria
BIORIVOLUMETRIA is an innovative concept in the field of HYALURONIC ACID-based injectiable medical devices.

 

 

REGENFLEX STARTER

1 syringe containing 2 ml of sterile pyrogen-free solution – (Hyaluronic acid sodium salt 1,6%)

REGENFLEX

1 syringe containing 2 ml of sterile pyrogen-free solution – (Hyaluronic acid sodium salt 0,8%)
REGENFLEX BIO-PLUS

1 pre-filled mono-use syringe (75 mg of reticulated hyaluronic acid in 3 ml buffered physiological solution).
 

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The same product makes it possible to simultaneously: restore the volume of the joint chamber by injecting CROSS-LINKED HYALURONIC ACID, and to stimulate receptors of the synoviocytes and chondrocytes thanks to the gradually released linear fraction of the INTERCALATED HA.

Intercalation process

Brochure

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