DescriptionSpecificationScienceIFU
Description

Biolevox™ HA MINI is a hyaluronic acid (HA) gel dedicated to the intra-articular injection into the small synovial joints effected by the osteoarthritis (OA) disease.

Specified HA-based gel contains 16 mg of sodium hyaluronate in 1 mL pre-filled syringe. Biolevox™ HA MINI is intended for intra-articular injection mostly into the temporomandibular joint, metatarsophalangeal joint, carpometacarpal joint, or interphalangeal joints. Designed HA-based gel contains hyaluronic acid with optimally high physicochemical parameters, such as molecular weight and concentration. Thus, Biolevox™ HA MINI is featured with its tailored viscosity property for the treatment of the smaller joints1.

As a result, Biolevox™ HA MINI is able to effectively lubricate cartilaginous surfaces and absorb the shocks that occurs during movement of the joint, as well as extinguish OA symptoms like ongoing inflammation and thus significantly improve OA patient’s quality of life2,3,4.

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 disease1 not only big synovial joint like knee or hip but also smaller joints.

Biolevox™ HA MINI contains a 16 mg sodium hyaluronate in a single injection of 1 mL volume. This optimal 1.6% concentration of hyaluronate provides very carefully selected viscosity, tailored in the range of 60-100 Pa*s, which is strictly dedicated for an intra-articular injection into small joints. Hyaluronate contained in Biolevox™ HA MINI is characterized with optimally high molecular weight of molecules that stays in the range of 1200 to 1400 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 an intra-articular HA treatment of smaller joints, providing long term clinical effect in OA patients2,3. The amount of the injections are directly dependent on the affected joint.

Therapy based on Biolevox™ HA MINI is perfectly safe as hyaluronan contained in the product is manufactured in fully controlled 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 injection2,4.

The administration of Biolevox™ HA MINI is recommended for 1-3 intra-articular therapy Clinical data show that intra-articular injection of hyaluronic acid gel with appropriately selected properties like one of Biolevox™ HA MINI is clinically effective in ameliorating OA symptoms for at least 6 months also in small joints5,6.

Package of Biolevox™ HA MINI contains single pre-filled syringe of 1 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 fluid1. HA is a biopolysacharide - it consists of a number of disaccharides bonded together into a long chain1.

HA is a crucial structural component of synovial joint as it acts as a lubricant, shock absorber, filler and metabolic agent2. OA development diminishes lubricating and shock absorption abilities of synovial fluid mainly by degradation of naturally produced HA3.
 

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 disease4.
 

Viscosupplementation

Intra-articular injection of HA restores and maintains viscoelastic properties of synovial fluid, thus enables improved lubrication and relieves pain5. HA exerts anti-inflammatory, analgesic and chondroprotective effects in synovial joints6. In long term, clinical benefits of viscosupplementation persist well beyond the intraarticular 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 homeostasis3. In consequence, viscosupplementation can improve joint function, thus allow return to normal physical activity and improve patient's quality of life7.

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 damage8.
 

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 homeostasis9
  • HA binds to special receptors - CD44 on cartilage and synovial cells in order to support matrix production10 and inhibit inflammation
  • HA affects OA-related nerve oversensitivity and reduce hyperalgesia11
  • HA diminishes inflammatory processes by reduction of proinflammatory mediators production and action12

Only high molecular weight HA is fully biologically functional

 

  • Only optimally high molecular weight HA possess the ability to protect articular cartilage from further damage by restoring  joint lubrication and joint homeostasis9
  • Only optimally high molecular weight HA is able to reduce OA-related pain13
  • Only  HA with optimally high molecular weight HA is able to reduce OA-related inflammation processes14
  • Only optimally high molecular weight HA is able to protect articular cartilage from OA-related degenerative changes and show clinical benefits15
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