GUNA COLLAGEN MEDICAL DEVICES

GUNA MD COLLAGEN :

The basis of all aesthetic treatments Dr. Genoveva Nagy

The peak of collagen biosynthesis in human beings occurs at the age of about 50 (Heine, 2009): from this moment on it undergoes a very fast downfall, and the same happens to elastin and proteoglycans. Dipartimento Scientifico Guna S.p.a.

LOW DOSE COLLAGEN BASED MEDICAL DEVICES

A NEW AND REFINED INJECTABLE TREATMENT OF THE AESTHETIC PROBLEMS

Dipartimento Scientifico Guna S.p.a.

LOW DOSE COLLAGEN BASED MEDICAL DEVICES

EFFICACYTOLERABILITY ABSENCE OF ALLERGIC REACTIONS NATURAL ORIGINEASY TO APPLY

Dipartimento Scientifico Guna S.p.a.

Ultrastructure of collagen. Native collagen fibril type I (images AFM).

Found in Skin, tendon, vascular, ligature, organs, bone

Collagen type I III make up 80-90% of collagen in the bodyDipartimento Scientifico Guna S.p.a.LOW DOSE COLLAGEN BASED MEDICAL DEVICES

How to apply MD TISSUE MD MATRIX to the skin

MD Tissue can be applied with the mesotherapy method (superficial, intradermal or tunneling injection).

For a session of Mesotherapy we only need:A syringeA needle

13 mm. Dipartimento Scientifico Guna S.p.a.4 mm.4 mm.30 G30 G27 GLENGHTGAUGEFace revitalizationwith tunelizationLocallized dipodistrophy

Classical mesotherapy needle

Dipartimento Scientifico Guna S.p.a.2,5 ml5 ml10 ml20 mlINSULIN

MD TISSUE Collagen based Medical Device with ancillary substances Low dose Collagen which supports, sustains and restores the collagen fibers of the connective tissue matrix

MD TISSUE ancillary substances which are essential to support the action of the CollagenVitamins B1, B2 and B6 are included for their antioxidant activity action against photoaging and protection of the matrix glycosaminoglycans Vitamin C is an important cofactor of transformation of Proline to Hydroxiproline; Magnesium gluconate is particularly important for their catalitic action on collagen methabolism

Fields of application of MD Tissue

Face and neck wrinklesScars and stretch marksSkin revitalizationLocal treatment of skin agingPreparation of the skin before surgeryActs as a barrier against free radicals

Misura delle distanze - Cun

ACUPUNCTURE POINTS FOR FACE REVITALIZATION1 - GALL BLADDER14 - GALL BLADDER

21 - TRIPLE HEATER

4 - STOMACH4e21 tr1 vb14vbTR = TH = TRIPLE HEATER; VB = GB = GALL BLADDER; E = ST = STOMACH; By courtesy of Dr De Bellis

THE MICROPAPULE: POINT TO POINT TECHNIQUECan be used for:

Skin revitalizationWrinklesStretch marksScarsBy courtesy of Dr De Bellis

By courtesy of Dr Frasca

By courtesy of Dr Frasca

TUNNELING techniquefor wrinklesIts a method involving the decollement of tissues triggering a small inflammatory reaction and leading to disappearance of wrinkles

By courtesy of Dr De Bellis

*FACE AND ANTERIOR NECK BIO-LIFTINGBy courtesy of Dr De Bellis

Nappage techniqueBy courtesy of Dr Frasca

PROTOCOL

Face revitalization can be used at any age.

DO NOT disinfect with alcohol

Superficial dermoabrasion is recommended before the treatment.

AREAS OF INJECTION Forehead Chin Cheeks NeckNot noseNot EyelidsTECHNIQUEPoint to Point O O O O O ONappageX X X X X X XFREQUENCY1 session per week for 5 weeks1 session every 2 weeks for 2-3 times1 session once every month for 2 months

Clinical observation on the efficacy of a low-dose Collagen Medical Device MD TISSUE as a face skin revitalizer (nasolabial folds)

20 female patients aged between 33 and 50 have been treated with weekly injections of a low-dose Collagen Medical Device MD TISSUE for 6 consecutive weeks.

1.0 ml ampoule has been injected exclusively into the nasolabial folds, 0.5 ml for each side.

The improvement of the wrinkle depth measured with the system Skin Surface Analizer SSA was averagely -21,44% after 6 weeks.

80% of the patients have self-assessed that they have seen a good reduction of both visibility and depth of wrinkles.

Efficacy of Collagen MD-TISSUE for revitalizing the face skinBeforewrinkle depth = 0,67 * volume mm2 X A.U(Adimensional Unit)After 6 weekswrinkle depth = 0,31* volume mm2 X A.U(Adimensional Unit)REDUCTION: -53,73% *measured with the computer system Skin Surface Analyzer SSA The photodocumentation of the face by Visioface Quick is courtesy of Evelyn Falconi Klein, MDOne 1.0 ml ampoule/week has been injected exclusively into the nasolabial folds,0.5 ml for each side; 27 G needles have been used

MD-TISSUE for revitalizing the skin & fine wrinkles1 session / weekBeforeAfter 6 weeksBy courtesy of Evelyn Falconi Klein, MD

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / weekBeforeAfter 5 weeksBy courtesy of Dr Frasca

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / weekBeforeAfter 5 weeksBy courtesy of Dr Frasca

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / week improvement of micro circulationBeforeAfter 5 weeksBy courtesy of Dr Frasca

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / week improvement of brown spotsBeforeAfter 5 weeksBy courtesy of Dr Frasca

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / weekBeforeAfter 5 weeksBy courtesy of Dr Frasca

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / weekBeforeAfter 5 weeksBy courtesy of Dr Frasca

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / week improvement of microcirculationBeforeAfter 5 weeksBy courtesy of Dr Frasca

*MD-TISSUE for revitalizing the skin & fine wrinkles1 session / week improvement of brown spots BeforeAfter 5 weeksBy courtesy of Dr Frasca

Indications: active forms of pathological scars

Contraindications: local inflammations, general acute form of any disease, hyperthermia, pregnancy,hypocoagulation, diabetes MD TISSUE for scar treatment

Clinical effect: reducing of scars volume, softening, ability to make a fold of skin, reducing of subjective feeling

Histological study: signs of reparative neoangiohenesis, the disappearance of rough, dense keloid tissues. Results of treatment

Recommendations for treating scars with MD-Tissue.Please remember scarring is a process, do not interfere with it.Modulate sun exposure.Place pressure on the scar. (a must).Drain The MATRIX.Practice massage on the new formed scar. (in a gently manner).Help the process inducing the correct formation of collagen.Keep a good nutrition.

SCAR TREATMENT TECHNIQUEBy courtesy of Dr Frasca

*SCAR TREATMENT TECHNIQUEBy courtesy of Dr Frasca

Indications: recent stretch marks (pink colour) to old stretch marks (white colours)

Contraindications: local inflammations, general acute form of any disease, hyperthermia, pregnancy, hypocoagulation, diabetes MD TISSUE for stretch mark treatment

Clinical effect: reducing of stretch mark volume.

Results of treatment

STRETCH MARKS TECHNIQUEBy courtesy of Dr Frasca

Fields of application of MD MATRIX:

Stimulation of connective tissue metabolism (cellulite & adiposity)

MD MATRIX Collagen based Medical Device with ancillary substances Low dose Collagen which supports, sustains and restores the collagen fibers of the connective tissue matrix

Citric acid is important to reactivate the cell metabolism by stimulating ATP production. Nicotinamide is an essential group B vitamin important in several metabolic processes. It is also a potent antioxidant that fosters tissue oxygenation.

MD MATRIX ancillary substances which support the action of the Collagen

MAJOR CAUSES OF CELLULITE(EFSP)

NORMALITYInteradiposity intersticeAdipocytesCapillaryNucleusReticulum ofpre-collagen reticular fibrils

Collagen is the basic component of the connective tissue, in fact its laxity, decay and intoxication are the main causes of cellulite, which affects 90% of women over 30 years of age.

Adiposity and cellulite are the final consequences of several contributing factors, such as, incorrect diet, little or no exercise, tension and stress.

All of these factors cause poor oxygenation of tissues and accumulation of waste material. When the waste removal system starts to fail, waste products build up and the connective tissue becomes saturated with liquid.Fatty cells (adipocytes) and the accumulated liquids push and distort the connective tissue, break collagen fibres and block blood and lymphatic flow.

PATHOLOGIC ASPECTS 1ST STAGEInitial adipocyteschangeIntersticesbroadeningmicroaneurysmsof capillariesEdematous transudate caused byan exaggerated increase of venular capillary permeabilityPATHOLOGIC ASPECTS 2ND STAGEVascularization changeCollagen fibrilsdiffering fromreticular fibrilsPre-collagen reticular fibrils during the hyperplastichypertrophic phaseEctasy,

EFSPIt is characterized by hypertrophy of fat cells (adipose cells), water retention and stagnation of fluids in intracellular spaces.

WHAT IS THE DIFFERENCE BETWEEN EFSP - CELLULITE - AND OVERWEIGHT? EFSP is localized in specific areas of the body that are generally symmetrical

it firstly affects the dermal or epidermal layer of skin without involving underlying tissues or internal organs

It secondly affects the adipocytes because it is an alteration of the connective tissue

It evolves independently, does not regress spontaneously and does not respond particularly well to diet.

Clinical classificationHard Cellulite

Transition phase Cellulite (mild)

Soft Cellulite

HARD CELLULITEBy courtesy of Dr De Bellis

MILD (TRANSITION PHASE) CELLULITE STAGE 2)By courtesy of Dr De Bellis

SOFT CELLULITEBy courtesy of Dr De Bellis

CELLULITE: ANTERIOR SYMPTOMATIC POINTS*By courtesy of Dr De Bellis

By courtesy of Dr De Bellis

CELLULITE: POSTERIOR SYMPTOMATIC POINTS*By courtesy of Dr De Bellis

By courtesy of Dr De Bellis

CELLULITE: LATERAL SYMPTOMATIC POINTS*By courtesy of Dr De Bellis

By courtesy of Dr De Bellis

ACUPOINTS for CelluliteMD Matrix will be injected in areas affected by cellulite & on acupuncture pointsThe acupuncture points are : 6 Spleen9 Spleen10 Spleen3 Kidney60 Urinary Bladder11 Liver

CELLULITE: SOME ACUPOINTSBy courtesy of Dr De Bellis

6 SpleenOn the medial aspect of the lower leg, 3 cun above the medial malleolus, on the posterior border of the medial aspect of the tibia.3 cun6 Spleen

9 Spleen On the medial aspect of the lower leg, in the depression of the lower border of the medial condyle of the tibia.

4GI4Gi9 spleen

10 SpleenWhen the knee is flexed, on the medial aspect of the thigh, the point is 2 cun above the mediosuperior border of the patella, on the bulge of the medial portion of m. quadriceps femoris. 10 spleen

60 Urinary BladderOn the foot, behind the external malleolus, in the depression between the tip of the external malleolus and tendo calcaneus.60 V

3 KidneyOn the medial aspect of the foot, posterior to the medial malleolus, in the depression between the tip of the medial malleolus and tendo calcaneus.

60 3 R

Treatment of Cellulite in Adult Females

Study DesignMulticentrum clinical observation

13 subjectsMD MATRIXWeekly mesotherapy sessions (baseline, wk 2,3,4,5,6,7,8)Measurements of cutaneous safety profiles, adverse events (baseline, wk 2,3,4,5,6,7,8) Measurements of thigh circumference (baseline, wk 2,3,4,5,6,7,8)

Thigh CircumferenceAverage Decrease in Thigh Circumference (cm) From Baseline

CONCLUSION: There is a significant decrease in thigh circumference from baseline to week 8 (3.77 cm average)

NR PATIENTSWeek 2Week 3Week 4Week 8130.541.151.693.77

LocalizedAdiposity

MAJOR CAUSES OF LOCALIZED ADIPOSITY

Poor oxygenation of tissues and accumulation of waste material and liquid in the connective tissue.

Disorders of lymph drainage adipocytes and the accumulated liquids push and spoil the connective tissue, break collagen fibers and block blood and lymphatic flow.

ADIPOSITY: GLUTEOUS SYMPTOMATIC POINTSBy courtesy of Dr Frasca

ADIPOSITY: ABDOMINAL SYMPTOMATIC POINTSBy courtesy of Dr Frasca

Clinical observation

20 subjectsMD MATRIXWeekly mesotherapy sessions (baseline, wk 2,3,4,5,6,7,8)Measurements of cutaneous safety profiles, adverse events (baseline, wk 2,3,4,5,6,7,8) Measurements of mid-arm circumference (baseline, wk 2,3,4,5,6,7,8)Treatment of Localized Fat Deposits (arms) in Adult Females

Mid-Arm CircumferenceAverage Decrease in Mid-arm Circumference (cm) From Baseline

CONCLUSION: There is a significant decrease in mid-arm circumference from baseline to week 8 (2.04 cm average)

NR PATIENTSWeek 2Week 3Week 4Week 8330.301.201.862.04

23 subjects with excess abdominal fat deposits aged 27-53 yearsMD MATRIXWeekly mesotherapy sessions (baseline, wk 2,3,4,5,6,7,8,9,10)Measurement of circumferences on the level of umblicus, Ren 6 and Ren 12 (baseline, wk 2,3,4,5,6,7,8,9,10).Clinical observationTreatment of Localized Fat Deposits (abdominal) in Adult Females

GB 26 On the lateral side of the abdomen, 1.8 cun below LIV 13, where the vertical line of the free end of the 11th rib and the horizontal line of the umbilicus intersect.Ren (CV) 12 On the anterior median line of the upper abdomen, 4.0 cun above the umbilicus.Ren (CV) 6 On the anterior median line of the lower abdomen, 1.5 cun below the umbilicus.Kd 16 On the middle of the abdomen, .5 cun lateral to the center of the umbilicus.Sp 15 On the middle of the abdomen, 4 cun lateral to the center of the umbilicus.St 25 On the middle of the abdomen, 2 cun lateral to the center of umbilicus.

Abdominal Localized Adiposity AcupointsOmeoformula 1 - (0,2 ml /injection 27G or 30 G 4mm needle)

Subcutaneous injection at 5-10 mm depth, using needles 27G and injecting 0,2 ml MD-Matrix acupointsDr. Elenkova - 5th Medical Acupuncture Congress, Barcelona 2011

RESULTSUmbilical circumferenceThe decrease is statistically significant: F(2,44)=4,276, p=0.020, analyzed with Repeated measures analysis.

Dr. Elenkova - 5th Medical Acupuncture Congress, Barcelona 2011

Dr. Elenkova - 5th Medical Acupuncture Congress, Barcelona 2011

Results before/ after on umbilical level -9 cm, Ren 6 9 cm, Ren 12 8 cm 10 sessionsBy courtesy of Dr Elenkova

Results before/ after reduction on umbilical level 11,5 cm, Ren 12 10 cm, Ren6 -13.5 cm10 sessions

By courtesy of Dr Elenkova

CONCLUSIONSThis clinical observation provides important positive data regarding the effectiveness of Acumesotherapy with MD Matrix in women with Localized Abdominal Adiposity.With a significant decrease of umbilical circumference at an average 6.2 cm can be concluded, that this combination ensures synergistic results- correction of localized excess fat deposits and restore of the physiological balance in treated tissue.

5th Medical Acupuncture Congress, Barcelona 2011

ADDITIONAL BENEFITS improved self- confidence and psychological comfort

regulation of defecation

normalization of menstrual cycle

5th Medical Acupuncture Congress, Barcelona 2011

GUNAPHORESIS

GUNAPHORESIS3 intensity levels (0,1,2) which correspond to different depths of magnetic field penetration: Level 0: 0-0,5 cm, Level 1: 0,5-1,5 cm, Level 2: 5-3 cm; The penetration depth also depends on the type of tissue treated and the level of cellular matrix drainage.220V electric current; digital timer.

GUNAPHORESISRESONANCE (INFORMATIONAL) MAGNETOPHORESISGUNAPHORESIS is a device for resonance (informational) magnetophoresis which exploits an Extremely Low Frequency (ELF) magnetic field emitting at low frequency (less than 100Hz) and low intensity (less than 100 Gauss).

Such ELF field (40 Gauss) is composed of a sinusoidal carrier (50Hz), modulated in width (information) by the bio photonic signals of GUNA products.

GUNAPHORESIS

GUNAPHORESISA response to low frequency magnetic stimulus (magnetic sinusoidal waves 50Hz) leads to a temporary increase of tissue permeability of the skin .

MAGNETOPHORESISW. Farone, W. Worthington, USPTO Application 20090093669, Magnetophoresis apparatus and method of useMagnetic field induces movement of the drug through dermal and mucosal layers, by interaction with magnetic moment of the drugmagnetizability magnetic moment

(iontophoresis: polarizability dipole moment)

MAGNETOPHORESISW. Farone, W. Worthington, USPTO Application 20090093669, Magnetophoresis apparatus and method of useIontophoresis movement of the molecules is longitudinal (aligned with the electric field)

agnetophoresis movement of the molecules is longitudinaland lateral (transversal to the field),it helps the molecules to move more easily around the obstacles (cell walls) and into the depth of the sub-dermal area

BEFOREIMMEDIATLY AFTER TREATMENT OF PATS LEFT SIDEBEFORE TREATMENT OF PATS LEFT SIDEIMMEDIATLY AFTER TREATMENT OF PATS LEFT SIDEGUNAPHORESIS + GEL BEAUTY + MD Tissue20 MINUTES / TREATMENTBy courtesy of Dr Frasca

BEFORE WHOLE FACE TREATMENTIMMEDIATE RESULT AFTER ONE SESSION OF FULL FACE TREATMENTBy courtesy of Dr Frasca

MAYJUNEJULYBEFOREAFTER 3 MONTHS THE RESULTS ARE STILL VISIBLEBy courtesy of Dr Frasca

BEFOREBEFOREAFTER 1 SESSION ON PATS LEFT SIDEAFTER 1 SESSION ON PATS LEFT SIDEGUNAPHORESIS + GEL BEAUTY + MD Tissue20 MINUTES / TREATMENTBy courtesy of Dr Frasca

BEFOREAFTER 1 SESSION FULL FACE IMMEDIATLY AFTERGUNAPHORESIS + GEL BEAUTY + MD Tissue20 MINUTES / TREATMENTBy courtesy of Dr Frasca

What are the contradictions for the procedure to the patient and to the person performing the magnetophoresis?The apparatus Gunaphoresis produces a very low magnetic field (ELF) that has no contraindications for the patient or for the operator. The effectiveness of this field is not due to the intensity but is due to information contained in it. GUNAPHORESIS receives information (resonance) via a digital signal generatedinside the device.

Are there any health and safety regulations concerning work safety in electromagnetic fields? Though the field is limited only to the area of application, it is generally not advisable to use any magnetic device in patients with pacemakers or pregnant women

How big is the focus of the field around the applicator?The field produced by Gunaphoresis is almost entirely magnetic (it is in fact generated by the coils present in the emitter probe and in the cylindrical shape emitter). The magnetic field produced is concentrated on the tip of the emitter probe and under the cylindrical shape emitter : the emission into the environment is practically zero.

ProtocolsFace revitalization, wrinkes: Gel Beauty + MD TissueIntensity: 11-2 sessions/week for 10 sessions

Skin: Gel Beauty + MD TissueIntensity: 11-2 sessions/week for 10 sessions

ProtocolsLocalized Adopisity: Gel Beauty + MD MatrixIntensity: 11-2 sessions/week for 10 sessions

CelluliteGel Beauty + MD MatrixIntensity: 11-2 sessions/week for 10 sessions

ProtocolsVeinous insufficiency: Gel Beauty + Omeoformula 5Intensity: 11-2 sessions/week for 10 sessions

**************