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Biolevox™ HA Tendon

Biolevox™ HA Tendon

Biolevox™ HA Tendon is hyaluronic acid (HA) gel especially designed for intratendinous or peritendinous injection as a double application therapy in order to alleviate the ongoing inflammation process and further recovery of the tendon functionality.
HA-based gel contains 32 mg of sodium hyaluronate in 2.0 mL pre-filled syringe. Importantly, Biolevox™ HA Tendon has optimally high molecular weight of HA molecules1 what together with high hyaluronic acid concentration provide optimal viscosity for product application.

Biolevox™ HA Tendon is designed to counteract the pathological alteration of the tendon tissue related with progression of tendinopathy and enthesopathy. Product upon intratendinous or peritendinous injection will extinguish the intense inflammation processes with concomitant catabolic action of enzymes2, stop the uncontrolled proliferation of the tendon cells and further counteract the negative changes of the tissue structure. Finally, the therapy with Biolevox™ HA Tendon double injections restore a proper tendon functionality and mechanics3.

Regular tendon overload or tissue trauma influence the homeostasis shifting into the direction of catabolic state aggravation with intense production of tissue degradation enzymes production, increased oxidative stress, and enhanced inflammation2. Pathology of tendon can be divided into tendinopathy (affects the entire tendon) or enthesopathy (affects the tendon attachment to the bone) and it is strictly connected to low healing potential of the tissue resulting in its highly elongated healing process.

Based on the clinical evidences, intratendinous or peritendinous injections of hyaluronic acid are suggested as conservative treatment of choice for tendon pathology1. Biolevox™ HA Tendon as product designed for intratendinous or peritendinous injection contains a optimal dose of 32 mg sodium hyaluronate in a single injection of 2 mL volume of gel. Contained HA molecules are characterized with optimally high molecular weight of molecules of 1400-1600 kDa which with optimal concentration of hyaluronate provides very carefully selected product viscosity at range of 70-200 Pa*s, tailored for its application.

Thus, therapy based on Biolevox™ HA Tendon with its tailored physicochemical properties, such as the optimally high molecular weight, concentration and viscosity, is able to extinguish catabolic processes and lead to the improvement of tendon function in patients with tendinopathy and enthesopathy. Importantly, hyaluronate molecules in Biolevox™ HA Tendon with this specific range of optimal molecular weight can induce appropriate biological response via CD44 receptors located on tenocytes cell membrane and thus provide most effective therapeutical outcome3.

Hyaluronan contained in the product is manufactured in fully controllable conditions by bacterial fermentation with use of Streptococcus sp. strain., providing the products that possess no possibility for uncontrolled tissue response upon the intratendinous or peritendinous injection, thus treatment based on Biolevox™ HA Tendon is safe4,5.

The administration of Biolevox™ HA Tendon is recommended as double intratendinous or peritendinous injection therapy with 7 days interval. Clinical data show that therapy based on intratendinous or peritendinous injection of hyaluronic acid gel with appropriately selected properties, like one in Biolevox™ HA Tendon is clinically effective in ameliorating tendinopathy symptoms for at least 12 months6.

Package of Biolevox™ HA Tendon contains single pre-filled syringe of 2 mL.

The product is meant to be used by medical practitioners only.

Hyaluronic acid in tendon issue
Hyaluronic acid (HA) is one of the fundamental components of tendon tissue, contributing to its mechanical properties and functioning1,2. HA occurs widely not only in the tendon extracellular matrix (ECM) but also in the cells close environment where it contributes to the mechanical support, viscoelastic and hygroscopic properties, and anti-inflammatory effects to cells and tissue3. HA is actively produced and stored within tendon sheath, which allows a smooth tendon gliding, and provides nutrition to tendon tissue itself4.
Repetitive or excessive loading, abnormal extension of the tendon tissue, or the fracture of the tendon might be a trigger tendinopathy induction. Tendinopathy or enthesopathy is a complex condition characterized by molecular, histological, and cellular changes appearing in affected tendons and nearby structures that leads to persistent, pain, swelling, and impaired physical performance. This condition can be also characterized by ineffective neovasularisation, decreased collagen I, and enhance collagen II production. Moreover, alongside the physical tendon damage, the response of the cells to the pathological stimuli is increased inflammation, together with the release of pro-catabolic molecules, like cytokines and chemokines and tissue degradation enzymes.
HA during the tendinopathy and enthesopathy
The implementation of the HA during the tendinopathy connects with a vast beneficial outcome. HA is involved in the tissue repair process regulation and tendon healing modulation, such as inflammation or cellular migration9. Furthermore, the implementation of the HA during the tendinopathy leads to decrease of the peripheral inflammatory response and promotes healing via tendon cells, in both repair site and synovial sheath3. It is proven that administration of HA inhibits the proliferation of fibroblasts and due to its anti-inflammatory actions, stimulates the synthesis of the endogenous HA in the tendons10.
HA vs Corticosteroids in tendinopathy and enthesopathy
HA intratendinous or peritendinous injections were proven to be clinically more efficient and safer than corticosteroid (CS) administration. This is based on the fact that despite CS’s broad use, its safety is put into serious consideration11. Scientific evidence shows that CS may influence tendon homeostasis, by disorganization of a collagen structure, which will lead to tenocyte viability reduction and increase in possibility of future tendon rupture8. Literature points out that CS decreases the fibroblasts proliferation rate and delays the healing of the tendon structure. This suggests that CS injection might disturb the early phases of tendon repair, regeneration and remodeling compared to HA12,13.
Mechanism of HA action in tendon
  • HA helps to establish homeostasis in tendon environment
  • HA acts as anti-inflammatory agent after tendon rupture14
  • HA with optimally high MW bind to CD44 receptors with further receptor clustering, which trigger the anti-inflammatory, wound healing, anti-angiogenic, and immunosuppressive actions3,15
  • HA inhibits tissue degradation processes by decreasing the matrix metalloproteinase (MMP) release16
  • HA promotes mechanisms of tendon repair by increases tenocytes viability and type I collagen production and deposition2

Materials:

A4_IFU_BHTEN_220674_8_ONLINE.pdf

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