Much more than just a filler

High Quality andSafety Standard

ISO 9001ISO 13485

M.A.C. TecnologyAccordance to GMP

guidelines

Visco-elastic cross-linked solutionfor dermal implantation

MACFILL DERMALPlus is a monophasic, biodegradable, viscoelasticand isotonic hydrogel intended for dermal tissue implantation.Its features of great rheological behavior and high plasticityare assured by patented technological process M.A.C.This process uniforms and adapt itself to the different viscosity featuresof jellified extracellular matrix inside dermal connective tissue so rending gel extremely uniform to deliver.

Purification Process MACMulti Activated Cross-link

ULTRASOUNDS BASEDRETICULATION PROCESS

M.A.C. Multi Activated Cross-linkMAC ultrasounds based cross-link process

NEW

The application of ultrasounds to hyaluronic acid gel,just obtained from bacterial fermentation, represents

a real technological innovationallowing to align molecular chains of the polymer,

so to make more effective the further reticulation phase(creation of covalent molecular bounds capable

to assure a huge grade of 3D polymer reticulation).

Multiphase of cross-linking to achieve the first reticulation with BDDE.

Gel activation after a double washing process and purification to enhance re-ticulation bounds. 3D Cross-linking and final purification to pull down residual bacterial endoto-xins and BDDE.

M.

A.

C.

D E R M A L P L U S

ReTiCulATion PRoCeSSwiTH ulTRASoundTeCHnoloGy

SKIN AREAS TO TREAT*

1- LIPS• Lips contour• Lips volume

• Peri-labial wrinkles

2- NOSE FOLDS• Middle nose folds• Deep nose folds

3- ChEEk BONES AND ChEEk• Cheek volume

• Cheekbone correctionand replacement

D E R M A L P L U S

* MACFILL DERMALPlus can be injected with 27 or 29 G needle (enclosed in the pack) to improve comfort of the patient and delivery uniformity.

PATIENT hOUSE PREPARATIONBefore the implantation with DERMALPlus:

• Assume FLAVOVEN CPS, 2 cps/die to improve vein vessels resistance and healthand reduce incidence of edema after implantation;

• Apply FACIAL C LOTION in the morning and night (Vit. C Palmitate 20% with dermo-trophic actionand capable to reduce dermal matrix depletion).

AMBULATORy PREPARATION BEfORE IMPLANTATION• Clean up the skin with OP LIQUID CLEANSER, effective demake-up agent and mild emollient of horny layer.

IMPLANTATION TEChNIQUE• Inject the gel with “retrograde tunnel technique” into the deep dermal layer;

• Massage accurately for some instants the skin area involved to promotea uniform distribution of the gel and avoid accumulation.

PROTOCOL AND DIRECTIONS TOCORRECTLy PREPARE fILLER IMPLANTATION

AMBULATORy PREPARATION AfTER IMPLANTATION• Soon after implantation, cool the treated zone for some instants (for example use skin cooler);

• Apply OP Emollient Foam (Zinc Oxide 15%) to reduce skin discomfort after injection.

hOUSE MANAgEMENT • Apply OP Lenitive Cream daily for one week after treatment in the morning and night after mild skin cleaning;• After 7th day apply OP Pluriattivo 3 on all the face, neck and décolleté, to enhance esthetic correction lasting

and reduce hyaluronic acid depletion after injection;• Assume Flavoven CPS (from 2 to 4 CPS/DIE as anti-edema agent);

• In case of Hyaluronic acid accumulation or formation of “curb” along injection site apply, within the first72 h after occurring, OP SAFETY GEL (hyaluronidase based nanoemulsion) up to complete risolution.

n.B. Is not advisable to expose to UV lights for at least 15 days after filler injection (Sun exposure, sunlamps, heat fonts).

PROTOCOL AND DIRECTIONSAfTER IMPLANTATION

More

treatment

information

PREPRE

POSTPOST

lineAR TeCHniQue wiTH ReTRoGRAde ReleASe

YES

lineAR TeCHniQue wiTH MiCRo-Bulk injeCTion

NO

D E R M A L P L U S

lineAR TeCHniQue wiTH AnTeRoGRAde ReleASe

NOdeRMAl TiSSue

HyPodeRMAl TiSSue

MuSCle PlAn

deRMAlTiSSue

HyPodeRMAlTiSSue

MuSCle PlAn

deRMAl TiSSue

HyPodeRMAl TiSSue

MuSCle PlAn

oSSeuS PlAn

SuB-PeRioSTeAl SPACe

• Concentration 2,3% (23 mg/ml-fiala) of reticulated hyaluronic acid• Reticulation agent BDDE (ButaneDiol Diglicidil Etere)• Residual Bdde 0,53 (ppm) ≤2 (ppm)• Average molecular weight >3.000.000 D of hyaluronic acid• Proteins 8,7 (ppm) <1000 (ppm) • endotoxins <0,05 (eu/ml) <0,5 (eu/ml) • Other excipients Phosphate buffer and Sodium chloride •pH 7,1 6,8-7,6•Osmolality 291(Mosm/Kg) 200-400 (Mosm/kg)• Extraction volume 1,0 ml • Dynamic viscosity 1.000.000 mPas

COMPOSITION DERMALPlus 1 ml EU Standards

• Lips volumetric enhancement• Nose-labila folds• Middle and deep wrinkles and folds

SAFETY OF USAGE• Iso 9001• Iso 13485• GMP normative (Good Manufacturing Practice)• Autoclave sterilization

PURITY• Pull down of the residual BDDE,endotoxins and proteins of bacterial origine

MANAGEABILITY• Viscoelasticity• Very low incidence of side effects

ESTEHTIC EFFECTIVENESS• Molecular weight > 3.000.000 D

D E R M A L P L U S

SKIN AREAS TO TREAT

MyCli by Mac Pharma S.r.l. - Via L. Scattolin, 26/1 - 31055 Quinto di Treviso (TV)Tel. +39 0422 470414 - Fax +39 0422 475572 - info@mycli.com - www.mycli.com

• n°1 syringe/vial with 1 ml provided of Luer Lock;• n°2 27 G needles;• n°2 29 G needles;• n°1 OP Emollient Foam - Anti-bruise and lenitive;• n°2 OP Liquid Cleanser sachets - Mild make-up remover;• n°2 OP Pluriattivo 3 Viso sachets - Antiage formulations for face, neck and décolleté with filler booster effect;• n°2 OP Lenitive Cream sachets - Emollient and normalizing effect;• n°2 OP Safety Gel sachets - Dermo-normalizing effect with hyaluronidase.

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The best volumetric performance…

MACFILL DERMALPlus is a reabsorbable, viscoelastic, biodegradable matrix basedon cross-linked hyaluronic acid, intended for the wrinkles and folds correction, skin depressions,

facial and lips volumes restoration and redefinition of profiles.