BIO-PLUS CROSS-LINKED HYALURONIC ACID. Mono-phase treatment for degenerative and trauma-caused diseases in all joints.

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1 CROSS-LINKED HYALURONIC ACID Mono-phase treatment for degenerative and trauma-caused diseases in all joints.

2 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 LOW MOLECULAR WEIGHT fractions (Free Hyaluronic Acid) VISCOSUPPLEMENTATION HIGH MOLECULAR WEIGHT fractions (cross-linked Hyaluronic Acid) REGENFLEX BIO-PLUS restores the levels of hyaluronic acid, that decrease naturally as the osteoarthrosis progresses: RELIEVES PAIN STIMULATES REPARATION

3 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 HIGH MOLECULAR WEIGHT FRACTION (HMWF) HMWF: cross-linked with BDDE HA 500 Dalton LOW MOLECULAR WEIGHT FRACTION (LMWF) 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 partially permeable dialyzing structure, the LMWF transits while normalizing the functions of macrophages and metalloproteases, and stimulating the synoviocytes, leading to the synthesis of endogenous hyaluronic acid. As it sets on the CD42 receptors, the LMWF also relieves pain. The HMWF stays inside the joint cavity and does not trespass the synovial membrane. As the HMWF transforms the phosphatise from acid into alkaline, it not only provides for an analgesic but also for a viscosupplementation effect.

4 HIGH MOLECULAR WEIGHT 1 LOW MOLECULAR WEIGHT 2 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

5 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 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): 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): 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): 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): e 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): 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): 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): 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

6 Member of CISQ Federation Prodotto da REGENYAL LABORATORIES Srl Via Valtellina, S. Benedetto del Tronto (AP) - ITALY ACCREDIA LʼENTE D I A C C R E D I T A M ENTO ISO 9001 Certified Quality System ISO Medical Devices - Certified Quality System ISO Certified Environmental System