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CHARACTERISTICS OF VARIOFILL BODY CONTOUR Copyright ADODERM GmbH

CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

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Page 1: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

CHARACTER IST ICS OF VARIOF I LL BODY CONTOUR

Copyright ADODERM GmbH

Page 2: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

CE 0297

Page 3: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

VARIOFILL – MANUFACTURING PROCESS

Page 4: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

A new generation of Hyaluronic Acid (HA)

Variofill® specifications below are a result of a new technology: “Monophasic Particle Technology (MPT) ” Formulation without dilution Cross linking grade: up to 80 % Cross linking agent: Divinylsulfone (DVS) Concentration: 33 mg/ml Packaging: 1x 10 ml

Copyright ADODERM GmbH

Page 5: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

The production process of Variofill®

Sodium hyaluronate (Bio-fermentation) dissolved in water

Through a new technology of an extended cross linking process with DVS a

degree of cross linking up to 80% always monitored for each batch will be

achieved.

DVS is completely washed out.

In cross linked sodium hyaluronate the hydroxyl groups of the disaccharide from

D-glucuronic acid and N-acetyl-D-glucosamine are cross linked to each other by

sulfonyl - to ethyl bridges. Sodium hyaluronate and DVS form a continuous

network and an aqueous gel during the reaction.

The highly concentrated and cross linked hyaluronic acid, which has a

significantly higher viscosity compared to the initial mixture, is subsequently

formed into particles and stabilized, to facilitate the filling of the syringes with a

slightly dilution. This method is described as new “Monophasic Particle

Technology” (MPT).

A new generation of Hyaluronic Acid (HA)

Copyright ADODERM GmbH

Page 6: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

PROOF FOR DVS-FREE PRODUCTS: PROTON-NMR SPECTRA

Divinyl sulfone Non cross-linked hyaluronic acid

Shift: 6.3 – 6.9 ppm Shift: 1.6 – 4.8 ppm

Copyright ADODERM GmbH

Page 7: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Adoderm

Varioderm 18 No peaks/echoes

from DVS

No peaks/echoes

from DVS

Varioderm

Subdermal 27

Shift: 1.5 – 5.0 ppm

Copyright ADODERM GmbH

PROOF FOR DVS-FREE PRODUCTS: PROTON-NMR SPECTRA

Page 8: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

4 times more cross linked than any other products on the market

33 mg/ml - highest concentration on the worldwide market

Excellent volume effect without overcorrection

Natural aesthetic and long lasting results

up to 18-24 months

Easy to inject without pre-testing with 16-20 G

blunt cannulas

Long filling effect merely after one treatment

To be stored at room temperature

A safe and effective product

Very strict quality controls guarantee that Variofill Body Contour® meets requirements

of European and International standards

Variofill Body Contour at a glance

Copyright ADODERM GmbH

Page 9: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Intracutaneous irritation in rabbit (10993-10)

Sensitization in mouse (10993-10)

Acute systemic toxicity (10993-11)

In-vitro cytotoxicity (10993-5)

Genotoxicity – reverse mutation assay on Salmonella typhimurium

(10993-3)

Genotoxicity - mammalian cell gene mutation assay (10993-3)

Sub chronic Toxicity and Subcutaneous Implantation - 6 months

(10993- 6 and 11)

Variofill Body Contour passed all

Biocompatibility testing according to

international standards

Copyright ADODERM GmbH

Page 10: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Copyright ADODERM GmbH

Biocompatibility – implantation test

Figure 4: Variofill gel 6 months after injection in rat hypodermis

Page 11: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Figure 3: Variofill gel 18 months after injection in rat hypodermis

Copyright ADODERM GmbH

BIOCOMPATIBILITY – IMPLANTATION TEST

Page 12: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Figure 5: After 18 months, Variofill Body Contour is still in place

in the capsula and without any inflammatory reaction.

Variofill Body Contour: histology human body

Copyright ADODERM GmbH

Page 13: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

INDICATIONS

Body deformities Pectus excavatus Calf

Gluteus area

Arms shaping after weight loss

Scars after lipo-aspiration

and cellulite dimorphic surface

Leg shape in gastroctemius area

Abdominal wall gap (peritoneal skin welding)

Face contouring

Copyright ADODERM GmbH

Page 14: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

EFFICACY OF VARIOFILL BODY CONTOUR

% o

f t

rea

ted

pa

tie

nt

Copyright ADODERM GmbH

Page 15: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

VOLUME VS. DURATION

INJECTED VOLUME (ML)

DURATION (MONTHS)

OTHER FILLER

MONOPHASIC /

BIPHASIC

VARIOFILL MPT TECHNOLOGY

Copyright ADODERM GmbH

Due to the high viscoelastic

properties of the Variofill and

higher concentration (33 mg/ml)

compared to others (Macrolane,

Hyacorp etc) – we recommend to

use 30-50% of Variofill less than any

other fillers for body contouring.

Page 16: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

BENEFITS FOR THE PATIENT

• Immediate filling effect

• Less product needed to be applied – due to its high

concentration in the 10ml syringe

• Longest retention time in the soft tissues (even up to 18-24 months)

• Body contour restored for longer

• Safe and well-tested product

• Natural aesthetic look without overcorrection

• Long satisfaction of the patient from the reliable treatment

• Variofill can be used for female and male patients (restoring the

body volume in desired areas)

Page 17: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Before starting treatment, please inform patients about:

Composition( highly cross linked hyaluronic acid)

Characteristics (osmolarity difference)

Precautions for use (prep the skin)

Indications ( select the area and indications)

Contra-indications (skin conditions and patient sensibility)

Incompatibilities (thin and insufficient skin thickness)

Potential adverse effects (swelling, redness etc.) of Variofill®.

Keep in mind

Copyright ADODERM GmbH

Page 18: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Before After

Variofill Body Contour injected subcutaneously in thorax 20ml by

Poland syndrome (male patient)

Copyright ADODERM GmbH

VARIOFILL BODY CONTOUR TREATMENT

Copyright ADODERM GmbH Copyright ADODERM GmbH

Page 19: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Variofill Body Contour injected in the arm, 5 ml per side

(female patient) (courtesy of Dr. Fisotto, Italy) Copyright ADODERM GmbH

Left arm Right arm

Before

After

Variofill Body Contour treatment

Copyright ADODERM GmbH

Copyright ADODERM GmbH

Copyright ADODERM GmbH Copyright ADODERM GmbH

Page 20: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Off label use of Variofill in Breast augmenation

Page 21: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Before After

VARIOFILL injected subglandular into breast 60ml(rb) and 70ml(lb)

Copyright ADODERM GmbH

Copyright ADODERM GmbH

Copyright ADODERM GmbH

Page 22: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Before After

VARIOFILL injected subglandular into breast 50ml(rb) and

40ml(lb)

Copyright ADODERM GmbH

Copyright ADODERM GmbH Copyright ADODERM GmbH

Page 23: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

Before After

VARIOFILL injected subglandular into breast 50ml(rb) and

40ml(lb)

Copyright ADODERM GmbH

Copyright ADODERM GmbH Copyright ADODERM GmbH

Page 24: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

VARIOFILL VS. MACROLANE AND HYACORP – PERFORMANCE COMPARISON

Macrolane

Hyacorp Variofill

Concentration 20 mg/ml 20 mg/ml 33mg/ml

Syringe 10 ml 10 ml 10 ml

Amount to inject to

obtain visible

effects (total

breasts)

100 ml 100 ml 60-70 ml

Buttock

augmentation

(average per side)

60-70 60-70 30-40

Duration 6 – 12 month

(claimed)

6 – 12 month

(claimed)

18-24 months

(proved)

Price *** ** ***

Copyright ADODERM GmbH

Page 25: CHARACTERISTICS OF VARIOFILL BODY CONTOUR · Hyacorp Variofill Concentration 20 mg/ml 20 mg/ml 33mg/ml Syringe 10 ml 10 ml 10 ml Amount to inject to obtain visible effects (total

VARIOFILL - CONCLUSION

• Highest concentration on the market (33 mg/ml) for the body contouring

• High degree of crosslinking degree (up to 80%)

• Excellent volume effect with less products applied

• Long duration of the filler in the skin – even up to 18-24 months

(competetive fillers: 6 months)

• Easy to inject

• 16-20 G blunt cannulas

• Secure and well-tested product

• Innovative "MPT" technology

• 8 years of full clinical data

• Made in Germany CE 0297


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