BIO-PLUS - Regenyal Laboratories

BIO-PLUS
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CRO URONIC
HYAL CID
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Mono-phase treatment for degenerative and trauma-caused
diseases in all joints.
BIO-PLUS
REGENFLEX BIO-PLUS
Cross-linked Hyaluronic Acid
The treatment is based on cross-linked and free Hyaluronic
acid and is designed to relieve pain caused by osteoarthrosis in the knee or hip in one single injection.
The HYALURONIC ACID is a component of the connective tissue. It is an integral and fundamental part of the
connective tissue’s supporting structure, and it plays an important role in the organization of the main macromolecular components.
The Acid’s function is to buffer and to lubricate a normal joint. As a matter of fact, it is used in orthopaedics,
rheumatology, physiatrics since a long time as the only substance that can restore the normal interaction
between glycogen and lactic acid. This is given by its properties:
REPARATIVE
VISCOSUPPLEMENTATION
LOW MOLECULAR WEIGHT fractions
HIGH MOLECULAR WEIGHT fractions
(Free Hyaluronic Acid)
(cross-linked Hyaluronic Acid)
REGENFLEX BIO-PLUS restores the levels of hyaluronic acid, that decrease naturally as the osteoarthrosis
progresses:
RELIEVES PAIN
STIMULATES REPARATION
DOUBLE MOLECULAR FRACTION
REGENFLEX BIO-PLUS is a transparent gel based on hyaluronic
acid, which is obtained through an advanced patented process.
Given the synergy between the cross-linked and free hyaluronic
acid it is possible to inject two molecular fractions in one single
administration:
1
2
HA 2 million + 1million Dalton
HA 500 Dalton
HIGH MOLECULAR WEIGHT FRACTION (HMWF)
LOW MOLECULAR WEIGHT FRACTION (LMWF)
HMWF: cross-linked with BDDE
LMWF: not cross-linked
Stabilized with the phosphate buffered saline, the product – without changes caused by amid links or similar
to the hyaluronic acid - enables the release of LMWF through dripping during the movement of joints.
Since the synovial membrane is an only partial-
The
HMWF stays inside the joint cavity
LMWF
and does not trespass the synovial mem-
transits while normalizing the functions of
brane. As the HMWF transforms the
macrophages
and
phosphatise from acid into alkaline, it not
stimulating the synoviocytes, leading to the
only provides for an analgesic but also for
synthesis of endogenous hyaluronic acid. As it
a viscosupplementation effect.
ly permeable dialyzing structure, the
sets on the
and
metalloproteases,
CD42 receptors, the LMWF also
relieves pain.
BIO-PLUS
1
2
HIGH MOLECULAR WEIGHT
LOW MOLECULAR WEIGHT
VISCOSUPPLEMENTATION
TROPHIC
ANALGESIC
RE-STRUCTURING
The FREE HYALURONIC ACID trespasses the synovial membrane and carries out a true therapeutic action:
REGULATES THE FUNCTION OF MACROPHAGES
NORMALIZES THE METALLOPROTEASE
STIMULATES THE SYNOVIOCYTES TO PRODUCE ENDOGENOUS HYALURONIC ACID
PROVIDES FOR ANALGESIC EFFECT AS IT OCCUPIES THE SITES OF CD42 (pain receptors)
REGENFLEX BIO-PLUS is injected into osteoarthrosis affected joints in order to relieve pain, restore the
natural lubrication and buffering, improve the functioning of joints and the quality of life.
The stabilized combination of hyaluronic acid in REGENFLEX BIO-PLUS enables a true RESTORATION OF
CARTILAGE.. The treatment can be injected by:
ORTHOPAEDISTS
RHEUMATOLOGISTS
PHYSIATRISTS
SPORTS DOCTORS
GERIATRISTS
REGENFLEX BIO-PLUS is a highly pure product, that guarantees maximum safety and efficiency. It is metabolized by
the human organism as the endogenous hyaluronic acid and no contraindications are known.
The hyaluronic acid can maintain keeps the joint fluids normally balanced and stimulates the restoration of normal joint
functioning.
REGENFLEX BIO-PLUS properties
NOT SUBJECT TO RISKS OF CONTAMINATION BY ANTIGENIC PROTEINS
EXCELLENT RHEOSTATIC STABILITY
RESISTANT TO ENZYME DEGRADING INSIDE THE JOINT
Ingredients
Cross-linked hyaluronic acid .................................................................................................................................75 mg
Phosphate buffer, water for injectable solutions . ......................................................................................................3 g
sodium chloride, phosphate buffer, water for injectable solutions
Indications
TRAUMATIC CHONDROPATHY
OSTEOARTHROSIS OF HIP OR KNEE
IATROGENIC DEGENERATIVE LESIONS (anti-inflammatory drugs and chemotherapy treatments)
Iniezioni monofasiche nelle patologie articolari
Mode of use
The intrinsic therapeutic properties of the Hyaluronic acid are respected and enhanced in REGENFLEX BIO-PLUS Therefore the product is an etiologic medical device that can be implemented in treatments of joint chondropathy of degenerative (diabetes, rheumatoid arthritis, iatrogenic caused by cortisone therapy) as well as of traumatic origin.
Administration
REGENFLEX BIO-PLUS is an in-office administered treatment and requires 10-15 minutes.
Many physicians, before the treatment, use a local anesthetic in order to minimize the irritations caused by the injection.
If used for prevention (especially in sportspeople) can be repeated every 6 months.
Dosage
For prevention or therapy every six months.
Bibliography
1. Hyaluronan: its nature, distribution, functions and turnover - Fraser, J. R. E.; Laurent, T. C.; Laurent, U. B. G., Journal of Internal Medicine, 1997; 242(1): 27-33.
2. The synthesis of hyaluronic acid by human synovial fibroblasts is influenced by the nature of the hyaluronate in the extracellular environment - Smith M.M.;
Gosh P., Rheumatology International, 1987; 7(3): 113-122.
3. Antalgic effect and clinical tolerability of hyaluronic acid in patients with degenerative diseases of knee cartilage: an outpatient treatment survey - Castellacci
E.; Polieri T., Drugs Exp Clin Res, 2004; 30(2): 67-73.
4. The Safety and Efficacy of Intra-Articular Dual Molecular Weighted Hyaluronic Acid in the Treatment of Knee Osteoarthritis: the I.D.E.H.A. Study - Shen X.; Gatti
R., Orthop Rev (Pavia), 2013; 5(4): e33.
5. Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee - Altman R.D.;
Åkermark C.; Beaulieu A.D.; Schnitzer T., Osteoarthritis Cartilage, 2004; 12(8): 642- 9.
6. A randomized saline-controlled trial of NASHA hyaluronic acid for knee osteoarthritis - Arden N. K.; Åkermarkb C.; Anderssonc M.; Todmand M.G.; Altman R.D.,
Curr Med Res Opin, 2014; 30(2): 279-86.
7. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial - Leighton R.; Akermark C.;
Therrien R.; Richardson J.B.; Andersson M.; Todman M.G.; Arden N.K., Osteoarthritis Cartilage,
2014;22(1): 17-25.
8. Intra-articular hyaluronic acid injection versus oral non-steroidal anti inflammatory drug for the treatment of knee osteoarthritis: a multi-center, randomized,
open-label, noninferiority trial - Ishijima M.; Nakamura T.; Shimizu K.; Hayashi K.; Kikuchi H.; Soen S.; Omori G.; Yamashita T.; Uchio Y.; Chiba J.; Ideno Y.; Kubota
M.; Kurosawa H.; Kaneko K., Arthritis Research & Therapy, 2014; 16(1): R18. Macerata, 5/05/2014
BIO-PLUS
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www.regenyal.eu
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REGENYAL LABORATORIES Srl
Via Valtellina, 21
63074 S. Benedetto del Tronto (AP) - ITALY
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