nasha TeChnOLOGy The key benefits

NASHA TECHNOLOGY ™ The key benefits Contents NASHA™ TECHNOLOGY Q-Med has created the NASHA technology, a science-based technological platform that...
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NASHA TECHNOLOGY ™

The key benefits

Contents

NASHA™ TECHNOLOGY Q-Med has created the NASHA technology, a science-based technological platform that makes it possible to design products with special properties to address different intended uses and patient needs.

Introduction

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NASHA™ Technology

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NASHA™ Gels - Intended Uses

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NASHA Technology - The Key Benefits

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References

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The cornerstones of the NASHA technology are to:

Recommended reading

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Use pure hyaluronic acid of non-animal origin The hyaluronic acid is manufactured biotechnologically by using cultured bacteria and subjected to comprehensive purification steps to obtain a very pure and consistent material.



Stabilize the hyaluronic acid raw material A minimal stabilization (< 1 %) is introduced to the hyaluronic acid molecule to obtain the desired physical form and to increase its residence time in the body.



INTRODUCTION Q-Med is a rapidly growing and profitable biotechnology/medical device company that develops, manufactures, markets and sells primarily esthetic and medical implants. The majority of the products are based on the company’s patented NASHA™ technology. Restylane® manufactured by Q-Med was the first hyaluronic acid–based dermal filler to be granted approval by the US-FDA, the global benchmark of proven clinical efficacy and safety. Q-Med has been run in its present form since 1995, operates world-wide and is listed in the Medium Cap segment of the OMX Nordic Stock Exchange in Stockholm, Sweden. The aim of this document is to present the NASHA technology, to address the benefits of using the NASHA gels and to outline their applications within the areas of facial beauty enhancement, body shaping and hospital healthcare.

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NASHA is a registered trademark of Q-Med AB.

NASHA™ GELS - INTENDED USES NASHA is a crystal-clear gel consisting of stabilized hyaluronic acid. NASHA technology has been used to specially design a wide range of products to fulfill your patient’s individual needs regarding facial beauty enhancement and body shaping, as well as products to address various medical applications. FACIAL BEAUTY ENHANCEMENT NASHA technology has been used to design a wide range of products to enable you to provide your patient with full face balance, dermal hydration and improved skin elasticity and tone. Thus, the NASHA gel products can be used to create facial skin volume and contouring, lip enhancement, correction of skin folds, moderate facial wrinkles and lines and for skin rejuvenation. It is safe and often advisable to combine different products of the Restylane range to address your patient’s needs and expectations. This procedure will ensure that the most optimal, long-lasting and natural results are achieved for each individual patient. This versatility is unique to NASHA technology. BODY SHAPING The NASHA gel product family also comprises specially designed products for volume restoration and contouring of body surfaces. The treatment is characterized by low invasiveness, instant results and long-term duration in the body. These products can be used for the correction of concave body deformities, trauma scars, scarring and asymmetry after liposuction, and for shaping and augmentation of body areas. HOSPITAL HEALTHCARE The hospital healthcare segment includes NASHA gel- based products for treatment of osteoarthritis in the knee and hip. In addition, NASHA gels containing dextranomer beads are used in Q-Med´s products for the treatment of vesicoureteral reflux in children and fecal incontinence in adults.

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NASHA™ TECHNOLOGY – THE KEY BENEFITS Compliance with international safety standards

Non-permanent products

Product development through science Tissue-tailored for maximum effect Superior lifting capacity Stimulation of collagen synthesis and skin revitalization Comprehensive customer support Scientifically documented efficacy

Non-permanent products Hyaluronic acid is a polysaccharide that naturally occurs in the body. NASHA products consist of a crystal clear gel of stabilized hyaluronic acid. The gel is biocompatible and readily becomes integrated into the tissue. It is non-permanent, i.e. it is biodegraded by the body’s own mechanisms and will thus disappear naturally over time. Superior lifting capacity NASHA gels are characterized by a superior skin lifting capacity, i.e. the ability to lift the skin under a wrinkle or a fold to achieve the desired esthetic effect. This is obtained because of the structure and the properties of NASHA gels which not only increase the volume of the skin but also stimulate new synthesis of structural components of the skin by dermal fibroblasts1. Stimulation of collagen synthesis and skin revitalization In a recently published study carried out on patients with photodamaged skin, injection of a NASHA gel stimulated new collagen synthesis by skin fibroblasts and the structure of the dermal matrix was thereby improved (Wang et al)1. The rejuvenating effect of a NASHA gels on aged facial skin has also been studied. The results obtained showed that the treatment generated a significant increase in dermal elasticity and decreased skin surface roughness (Kerscher et al)2. Tissue-tailored for maximum effect All NASHA gels are specially designed in order to meet the patient’s needs and the anatomy and physiology of the skin. Gel particle size, structure and characteristics are carefully adjusted to match the different layers of the skin and the various intended uses, in order to achieve maximum esthetic results. The versatility of the NASHA gel product range allows you to optimize the esthetic enhancement effect for each individual patient.

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Scientifically documented efficacy Q-Med has through several scientifically documented clinical studies obtained an extensive amount of data demonstrating the efficacy and the duration of the NASHA™ gels3,4. Clinical trials show that the duration of the esthetic enhancement lasts considerably longer than several other non-permanent esthetic treatments4. The response is, however, individual and depends on the injected NASHA gel and the desired esthetic effect.

Compliance with international safety standards •

NASHA gels contain stabilized non-animal hyaluronic acid of high purity. Therefore there is essentially no risk of hypersensitivity reactions due to the presence of potentially harmful contaminants such as viruses, proteins and endotoxins, as is the case when using products containing hyaluronic acid from animal sources.



NASHA gels are associated with a minimal rate of transient adverse events (0,04 -0,15 %), after > 9 million reported treatments worldwide5. The most commonly observed adverse events are injection-related reactions such as swelling, erythema, tenderness and pain, which are resolved spontaneously within 1-2 weeks 6.



The clinical documentation obtained through either investigator initiated or sponsored initiated studies on the safety of NASHA gels is readily available to all customers 4.

• NASHA gels are produced in accordance with rigorous EU safety standards. The manufacturing process complies with the internationally recognised ISO 13485:2000 standard and the local requirements of markets in which the products are registered. The biocompatibility of Q-Med’s esthetic and medical implants has been clinically and scientifically tested. The testing has been conducted according to guidelines in the ISO10993 standard on ‘Biological Evaluation of Medical Devices’.

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Product development through science • Q-Med has a well developed Research and Development (R&D) department constantly working on product innovation and optimization of treatment techniques. • NASHATM gels and the raw materials used in the manufacturing process are subjected to stringent microbiological and chemical quality control. This is achieved by analytical methods specially developed to warrant the purity and safety of the products. • Products are designed by multi-disciplinary teams including experienced medical professionals.

Comprehensive customer support • Q-Med strives to provide full training and support through workshops, live demonstrations with the participation of experienced users and physicians, and by continuously supplying product information and clinical results. • Customers are assisted to further develop business opportunities and patient management in order to increase the patient’s satisfaction. • The company has a world-wide adverse event reporting system to record and evaluate reported adverse events in order to follow up the safety of the patients7.

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REFERENCES 1.

Wang F, Garza LA, Kang S, Varani J, Orringer JS, Fisher GJ, Voorhes JJ. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamaged skin. Arch Dermatol 2007; 143:155-163.

2.

Kerscher M. , Reuther, T., Bayrhammer, J., and Krüger, Study of the effects of stabilized non-animal hyaluronic acid on the biophysical properties of the skin, Dermatol Surg, 2008 (In the press).

3.

Narins RS, Brandt F, Leyden J, Lorenc PZ, Rubin M, Smith S. A randomized, double-blind multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg 2003;29:588-95.

4.

The Restylane® Publications booklet, 6th edition, 2007.

5.

Q-Med data on file, 2007.

6.

De Lorenzi C, Weinberg M, Solish N, Swift A. Multicenter study of the efficacy and safety of subcutaneous non-animal stabilized hyaluronic acid in aesthetic facial contouring: Interim Report. Dermatol Surg 2006;32(1):208-21.

7.

Periodic safety update reports. Q-Med AB, 2006.

Recommended reading André P. Evaluation of the safety of non-animal stabilized hyaluronic acid (NASHA-Q-Med, Sweden) in European countries: a retrospective study from 1997-2001, JEADV 2004; 18:422-425. Carruthers A, Carey W, DeLorenzi C, Remington K, Schachter D, Sapra S. A randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, Restylane Perlane and Hylaform, in the treatment of nasolabial folds. Dermatol Surg 2005;31(11)Part 2:1591-1598. Friedman PM, Mafong EA, Kauvar ANB, Geronemus RG. Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation. Dermatol Surg 2002;28(6): 491-494. Lindqvist C, Tveten S, Eriksen Bondevik B, Fagrell D. A randomized, evaluator-blind, multicenter comparison of the efficacy and tolerability of Perlane versus Zyplast in the correction of nasolabial folds. Plast Surg 2005; 115(1):282-289. Lowe NJ, Grover R. Injectable hyaluronic acid implant for malar and mental enhancement. Dermatol Surg 2006;32:881-885.

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15-79425-05

Sweden Q-Med AB (publ) Corp. reg. number: 556258-6882 Seminariegatan 21 Visitor’s address: Fyrisvallsgatan 7 752 28 Uppsala, Sweden Tel +46 18 474 90 00 Fax +46 18 474 90 01 [email protected]

China - Hong Kong Q-Med International Ltd Kodak House II Rm 2207-08 22/F 39 Healthy Street East North Point, Hong Kong Tel +852 2516 5002 Fax +852 2516 5810 [email protected]

Australia Q-Med (Sweden) Australia Pty. Ltd. PO Box 379, Woollahra, Sydney, NSW 1350, Australia Visitor’s address: 37 Belmore Street Surry Hills, Sydney, NSW 2010, Australia Tel +61 2 9281 7727 Fax +61 2 9281 4434 [email protected]

China - Shanghai Q-Med International Trading (Shanghai) Ltd Room 2017 No 1 Ji Long Road, Waigaoqiao Free Trade Zone Shanghai, China Tel +86 10 8532 1642 Fax +86 10 6532 7310

Benelux Q-Med Benelux B.V. PO Box 7241 Visitor’s address: Naritaweg 165 1043W Amsterdam, Netherlands Tel +46 18 489 1520 Fax +46 18 474 9001 [email protected] Brazil Q-Med Brasil Comércio e Importação de Produtos Médicos Ltda Avenida das Americas No. 500 Bloco 9 sala 123, Barra da Tijuca 22640-100 Rio de Janeiro, Brazil Tel: +55 21 3139 9968 Fax: +55 21 3153 7615 [email protected] Canada Q-Med Inc. 703 Evans Avenue, Suite 504 Toronto, Ontario M9C 5E9, Canada Tel +1 416 513 1323 Fax +1 416 513 1325 Toll Free Phone: 1 877 750 3456 [email protected]

Mexico Q-Med Mexico S.A de C.V Iglesia 2 Torre E Despacho 503 Colonia Tizapán San Angel Mexico, D.F.C.P.01090, Mexico Tel +52 55 5616 8292 Fax +52 55 5616 8306 [email protected] Poland Q-Med Polska Sp. Z.o.o Nowy Swiat 47 00-042 Warsaw, Poland Tel +48 22 892 91 20 Fax +48 22 892 91 29 [email protected]

France Q-Med S.a.r.l. 49 rue de Lisbonne 75008 Paris, France Tel +33 1 56 43 43 00 Fax +33 1 56 43 43 01 [email protected]

Spain Q-Med Spain S.L. Parque Empresarial Alvia Edificio 3, Planta Baja, Módulo 1 C/ Jose Echegaray 8 28230 Las Rozas (Madrid), Spain Tel +34 91 636 9205 Fax +34 91 630 1402 [email protected]

Germany Q-Med GmbH Berliner Ring 89 64625 Bensheim, Germany Tel +49 6251 770 790 Fax +49 6251 770 7911 [email protected]

UK Q-Med Ltd 10 Dean Farrar Street, 6th Floor London, SW1H0DX, England Tel +44 20 7976 3290 Fax +44 20 7976 3299 [email protected]

Italy Q-Med ICT S.r.l. Via M.Borsa, 11 26845 Codogno (LO), Italy Tel +39 0377 436091 Fax +39 0377 436087

USA Q-Med Scandinavia Inc. 103 Carnegie Center Suite 301 Princeton, NJ 08540, USA Tel +1 609 269 1100 Fax +1 609 269 1101 Toll Free Phone +1 877 959 3300 [email protected]

[email protected]

Q-Med AB • Seminariegatan 21 • SE-752 28 Uppsala • Sweden • Phone: +46(0)18-474 90 00 • Fax: +46(0)18-474 90 01