OSMOSIXS Press Kit

OSMOSIXS Press Kit

1 A TRUE REVOLUTION IN THE WORLD OF SPORT Combating fatigue has always been the goal sought after by generations of athletes. Trainers and sports me...

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A TRUE REVOLUTION IN THE WORLD OF SPORT Combating fatigue has always been the goal sought after by generations of athletes. Trainers and sports medicine consider lactate threshold an excellent indicator of an athlete’s potential resistance. The ability to exercise intensely without building up lactic acid is highly advantageous. Today, thanks to the agreement signed by SIXS and LVM Technologies, we are able to announce that the goal has finally been reached.

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Results of medical tests which used the LVM technology testify to the efficiency of the system, consultancy activities by the Universities of Pisa, Pavia and Ferrara underline it’s unique features, tests undertaken in Italy’s most important athletic training and sports research centre confirm it, the textile experience of SIXS has given it form.

is born

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THE PRINCIPLE: The application possibilities are endless, going from energy to new materials. One of the main applications is in the health and sport field. Although the beneficial effects of many active ingredients have been known for a while, a practical system, free from any collateral effects, is not always known which provides for the application of active ingredients in the right amount and at the right place in order to gain the best results. THE MICROENCAPSULATION OF THE ACTIVE INGREDIENTS ADMINISTERED VIA TRANSDERMAL DELIVERY, MAXIMISES BIOAVAILABILITY AND THEREFORE OPTIMISES THE INGREDIENT’S EFFICIENCY. For example, in the medical field, some skin conditions (diabetic foot infections, inflammation of amputated areas etc.) have been cured by use of LVM technology. In these cases, the suitable active ingredient was known, but the right system of

APPLICATION:

MICROTECHNOLOGY application had not yet been found. The use of LVM technology guarantees the possibility to deliver the active ingredient at a constant rate and at the right place, and in the right amount. LVM technology concerns the design of a molecular film and of the necessary process to transform various active ingredients into microcapsules. The LVM molecular film is integrated into a specifically designed textile structure and is characterised by the fact that it can be recharged with microcapsules containing the active ingredient to be used. The release of the active ingredient occurs over a longer period and at a constant rate, beginning only when the textile structure is put on, and activated by the change in temperature together with the microfriction with the skin.

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The transfer of this technology from the medical to the sporting field opens up further interesting application possibilities. The first active ingredient considered in this field is CARNOSINE, a natural antagonist to lactic acid . The problem with Carnosine is that when it is taken orally

(the only system currently in use) and is only absorbed by the organism at a maximum of 8-10%. Via transdermal OSMOSIS (thus the need to “wrap” the ingredient in a molecular film containing microcapsules) it is absorbed by the deepest layers of the epidermis, in a markedly higher amount and already localised.

THE PRODUCT: Following the specifications of LVM, a range of different products have been conceived which are suitable for use in a variety of sporting situations such as cycling and motorcycling. The areas of release are the muscle groups which are most used in the various situations.

Therefore stockings have been created with a release area in the sole of the foot (the most receptive area of the body), pads of different dimensions with release areas on the calves and vastus medialis thighs, and shirts with release areas on the forearm and biceps.

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USE: Items are delivered ready for use and charged with amicrocapsules containing Carnosine. In the packaging, as well as instructions, three recharging doses will be included. As well as single packs, recharging doses will be available in bottles of around 20 and 40 measures. The continued use of OSMOSIXS has a soothing effect and buffers muscular fatigue caused by the build-up of lactic acid during sporting performance. It also improves recovery after activity.

Release is activated from the moment the item is put on (item should be worn at least one hour before the beginning of the sporting performance) and it lasts around 36 hours. After every use it is necessary to recharge the OSMOSIXS item with the specific recharging measures of Carnosine molecular film, with a simple charge operation which can be done at home. Dissolve the right recharging dose in water and leave the item soak for around 20 minutes.

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MICROSYSTEMS WITH ACTIVE INGREDIENT CONTROLLED RELEASE THROUGH THE FABRIC ITALIAN RESEARCH AND DEVELOPMENT COMPANY LVM has years of experience in the study of microtechnology and innovative transdermal release systems. In collaboration with universities and international scientific authorities DIFOPREV has been created (PCT European patent): the first bio-technical application which has revolutionised the treatment of diabetic foot infections.

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MAIN COLLABORATIONS

Amb. of Podology University “La Sapienza” Roma

University of Dermatology H. S.Orsola of Bologna Prof. A. Tosti

Hight Frequency Diagnostic Ultrasound Cambridge University (UK) Dr. S. Young

Diabetology National Health Service Naples 1 ANIAD (Italian National Association of Diabetic Athletes) Dr. Luca Avagnina

Medical Devices

Endocrinology Department UniversityClinic Ljubljana, Slovenia D.r Vilma Urbancic

Research Center Mapei Sport Castellanza (VA)

Centre for prothesis INAIL Budrio Prof. T. A. Moscato

TREATED FABRIC

NON - TREATED FABRIC

Research Centre Phlebology University of Ferrara Dr. V. Gasbarro

Centre for the prevention and treatment of diabetic foot infections IRCCS Multimedica Sesto San Giovanni Dr. G. Clerici

LVM - R&D

Pharmacology Faculty University of Pavia

Vascular Diagnostics Centre H. Maggiore in Bologna Dr. Leonardo Aluigi

Area: diabetic foot infection Metabolic illnesses and Diabetes Dept. Endocrinology University Clinic of Pisa University of Pisa Professor A. Piaggesi

Centre of Vulnology Ist. Zucchi Monza Dr. R. Brambilla

Rehabilitation sciences Sports podology SIPU (It. Univ. Society of Podology) Dr. Luca Avagnina

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SOME EXAMPLES OF EFFICIENCY IN THE MEDICAL FIELD

DIFOPREV GA LARGE AMPUTATIONS

MEDICAL DEVICES CLASS I AND CLASS IIA • WOUND CARE distributed by SMITH & NEPHEW • PHLEBOLOGY distributed by PHARMENTIS

A new possible therapy for skin issues at the stump of an amputation.

• LARGE AMPUTATIONS distributed by SMITH & NEPHEW

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MAJOR COLLABORATIONS 2005 L. Aluigi, G. Pirotta – Prevention of “DIABETIC FOOT” preliminaryresults of a new delivery system with cosmetic microcapsules - Podium presentation - IFSCC World Wide Wellness - Proceedings Cosmetics 2005 International conference - Firenze, 19-21 Settembre 2005. 2005 E. Banchellini, L. Ambrosini, A. Civitelli, S. Macchiarini, E. Leporati, V. Sciré, I. Teobaldi, A. Piaggesi - Valutazione del nuovo sistema DIFOPREV nella prevenzione e nel trattamento delle condizioni Preulcerative nei pazienti con piede diabetico neuropatico: uno Studio prospettico randomizzato - Podium presentation - Congresso Piede Diabetico 2005 - Firenze 5-7 Dicembre 2005. 2006 E. Banchellini, L. Ambrosini, A. Civitelli, S. Macchiarini, E. Leporati, V. Sciré, I. Teobaldi, A. Piaggesi - Applicazione delle nanotecnologie Alla gestione delle condizioni pre-ulcerative nel piedediabetico Neuropatico - Poster session – 21° Congresso Nazionale SID - Milano, 17-20 Maggio 2006. 2006 R.Piro, F.De Bernardinis, G.Grossi,S.Carnevale - Trattamento di Prevenzione e Ripristino della cute nel piede diabetico con siste-

2009 A.Piaggesi, L.Rizzo, A.Tedeschi, A.Scatena, C.Goretti, S.Del Prato -Measurements in Diabetic Foot - Publication Journal Of Wound Technology – Edition MF – Paris - France Gennaio 2009

2006 L. Aluigi – Educazione e prevenzione piede diabetico - Podium Presentation – Giornate Nazionali di angiologia XXVIII Congresso Nazionale SIAPAV – Roma Novembre 2006

2008 E. Banchellini, S. Macchiarini, V. Dini, L. Rizzo, A. Tedeschi, A. Scatena, C. Goretti, F. Campi, M. Romanelli, A. Piaggesi - Use of nanotechnology- Designed footsock in the management of preulcerative conditions in the Diabetic foot: results of a single, blind randomized study - Publication The International Journal of Extremity Wounds - USA - Giugno 2008

2007 Banchellini, L. Ambrosini, V. Dini, L. Rizzo, M. Romanelli, A. Piaggesi - Nano technologies for the treatment of preulcerative Condition of the diabetic foot - a prospective randomized trial - Podium presentation - V International Symposium on the diabetic foot -9-12 May 2007, Noordwijkerout – Netherands

2008 E. Banchellini, S. Macchiarini, V. Dini, L. Rizzo, L. Abruzzese, A. Tedeschi A. Scatena, C. Goretti, M. Romanelli, A. Piaggesi – Nanotechnologies for The management of preulcerative conditions in the diabetic foot - Poster session - Seven meeting of DFSG - 11-14 Settembre 2008 Il Ciocco Castelvecchio Pascoli Italy

2010 S.Manfredelli, I.Martire, F.Passafiume, N.Di Tullio, A.Forte, A. Lorenzotti, V.Malagnino, A. Chiaravalloti, M. Bezzi, F. Vietri, P.G.Pastore - Trattamento della neuropatia autonomica nella prevenzione delle ulcere del piede diabetico - Acta Vulnologica Roma Giugno 2010

ma Difoprev - podium presentation - Piede diabetico la realtà centro-Meridionale - 19-21 Ottobre 2006 - Paola (CS)

2007 A. Piaggesi - Facing the challenge of prevention in the diabetic Foot - Podium presentation - 13° National Congress of Internal Medicine 8-13 Ottobre 2007 - Athens - Greece

2008 Douglas H. Richie jr., DPM - Therapeutic hosiery: An Essential Component Of Footwear for the Pathologic Foot – Publication Footwear & Podiatry - Podiatry Management - East Islip - NY USA - Ottobre 2008

2008 Pirotta - Skin delivery of active ingredient from fabric Publication“Cosmetic & Toiletries” Allured Publishing Corporation USA, Aprile 2008

2008 H. Hosalcar, MBMS, FCPS, DNB, J. Hsu, N.K.Pandya and M. A. Keenan - What’s news in Orthopaedic Rehabilitation - Publication The Journal of Bone And Joint Surgery - USA Ottobre 2008

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2010 A.Piaggesi - DF care in Italy - Publication Wounds International-London Febbraio 2010

2011 E.Banchellini, L.Abruzzese, L.Ambrosini Nobili, E.Leporati, S.Macchiarini, I.Teobaldi, A.Piaggesi - Nanotechnologies for the prevention and treatment of pre-ulcerative lesions of the ischemic footPodium presentation - VI° International Symposium on the diabetic foot – 11-14 May 2011, Noordwijkerhout, Netherlands 2012 Lan-Anh Lem Ross J Hunterm Victor R Preedy-Nanotechnology and Nanomedicine in Diabetes Pubblicazione Taylor & Francis Inc Science Publishers U.S.- Marzo 2012.

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2012

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