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Biolevox™ HA ONE

Biolevox™ HA ONE

Biolevox™ HA ONE is a hyaluronic acid (HA) gel, especially designed for a single intra-articular injection in order to ameliorate symptoms of the osteoarthritis (OA) in synovial joint.

HA-based gel product contains 120 mg of sodium hyaluronate in 4.8 mL prefilled syringe. A unique combination of optimally high molecular weight and high concentration of hyaluronate in Biolevox™ HA ONE creates a gel characterized with optimally high viscosity and elasticity! Thus, Biolevox™ HA ONE stands as an ideal solution for a single shot viscosupplementation therapy as it provides a very high dose of optimally high molecular hyaluronate in single injection.

As a result, upon the injection, Biolevox HA ONE is able to effectively lubricate cartilaginous surfaces and absorb the shocks that occur during movement of OA-affected joint in which synovial fluid properties have been highly compromised?.

Unquestionably, Biolevox ™ HA ONE due to its unique physicochemical properties is able to ameliorate OA symptoms like pain and joint mobility limitation and thus significantly improve OA patient’s quality of life?.

Specification:

Viscosupplementation, so intra-articular injection of HA, is scientifically and clinically approved practice for reducing joint pain, improving functional condition of OA-affected joint, finally delaying the progression of the disease.

Importantly, treatment based on the single intra-articular injection of HA demonstrates a therapeutic effectiveness and significant improvement of the OA symptoms leading to recovery of patient’s quality of life?.

Hyaluronate contained in Biolevox™ HA ONE is characterized with optimally high molecular weight of molecules that stays in the range of 1800 to 3200 kDa.

HA-based gel with such unique properties improves shock absorption and lubrication of the cartilaginous surfaces as well as reduces inflammation state due to appropriate biological response via CD44 receptors. Moreover, such content is particularly tailored for a single intra-articular HA treatment, providing long term clinical effect in OA patients 3.4.

Therapy based on Biolevox™ HA ONE is perfectly safe as 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 intra-articular injection 3,5

The administration of Biolevox™ HA ONE is recommended as single intra-articular therapy. Clinical data shows that single intra-articular injection of hyaluronic acid gel with appropriately selected properties, like one of Biolevox™ HA ONE is clinically effective in ameliorating OA symptoms for at least 6 months

Package of Biolevox™ HA ONE contains single pre-filled syringe of 4.8 mL.

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

Science:

Hyaluronic acid and viscosupplementation

Hyaluronic acid (HA) is one of the major constituent of articular cartilage extracellular matrix and synovial fluid’. HA is a biopolysacharide – it consists of a number of disaccharides bonded together into a long chain!.

HA is a crucial structural component of synovial joint as it acts as a lubricant, shock absorber, filler and metabolic agent?. OA development diminishes lubricating and shock absorption abilities of synovial fluid mainly by degradation of naturally produced HA?.

Viscosupplementation, so intra-articular injection of HA, is scientifically and clinically approved practice for reducing joint pain, improving functional condition of OA-affected joint, protecting cartilage and finally delaying progression of the disease

Viscosupplementation

Intra-articular injection of HA restores and maintains viscoelastic properties of synovial fluid, thus enables improved lubrication and relieves pain. HA exerts anti-inflammatory, analgesic and chondroprotective effects in synovial joints®.

. In long term, clinical benefits of viscosupplementation persist well beyond the

intra-articular residence of HA since clinical benefits achieved by HA intra-articular injection occurs due to increase of naturally produced HA in synovial joint thus reestablishment of joint homeostasis?.

. In consequence, viscosupplementation can improve joint function, thus allow return to normal physical activity and

improve patient’s quality of life?.

Importantly, many scientific comparisons and clinical investigations show that intra-articular HA injection is comprehensively safe, in contrast to steroid intra-articular injection that can lead to cartilage thinning and damage?.

HA intra-articular mechanism of action

  • HA restores viscoelastic properties of OA-affected synovial fluid thus improves lubrication
  • HA induces synthesis of natural hyaluronic acid thus contributes to recover of joint homeostasis?
  • HA binds to special receptors – CD44 on cartilage and synovial cells in order to support matrix production’ and inhibit inflammation
  • HA affects OA-related nerve oversensitivity and reduces hyperalgesia”
  • HA diminishes inflammatory processes by reduction of proinflammatory mediators production and action 2

Only high molecular weight HA is fully biologically functional

Only optimally high molecular weight HA possesses the ability to protect against articular cartilage damage by restoring joint lubrication and joint homeostasis®

  • Only optimally high molecular weight HA is able to reduce OA-related pain 13
  • Only HA with optimally high molecular weight HA is able to reduce OA-related inflammation processes 4
  • Only optimally high molecular weight HA is able to protect articular cartilage from OA-related degenerative changes and show clinical benefits 15

 

Materials:

IFU-BHOEN-220047_6_ONLINE.pdf

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