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VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and...

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VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE CUTTING EDGE OF SCIENCE
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Page 1: VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and absorbable, Algeness®, does not contain cross-linked synthetic chemicals (BBDE or PEG)

V O L U M I Z I N G B I O D E G R A D A B L E

I N J E C TA B L E I M P L A N T

O N T H E C U T T I N G E D G E O F S C I E N C E

Page 2: VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and absorbable, Algeness®, does not contain cross-linked synthetic chemicals (BBDE or PEG)

A G A R O S E M O L E C U L E

OH

OH HOn

H OO

OO

O

OH

OH

I N T R O D U C T I O N

While the demand for minimally invasive procedure treatments increases,

the fillers’ market is experiencing a growing number of publications of im-

mediate or latent reactions associated with Hyaluronic Acid (HA) fillers or

other chemically based fillers. Patients and the scientific community are

trending to natural and biocompatible dermal fillers without chemicals for

a safe and effective solution for consistently excellent outcomes.

In response to the physician and patient needs, Advanced Aesthetic

Technologies, Inc. (AAT), a Boston, MA USA based company, employing

bio-technologies in the aesthetic medical field, has launched Algeness®, the

100% natural and biodegradable injectable implant, the culmination of 10

years of scientific and clinical research.

W H A T I S A L G E N E S S ® ?

Algeness® is a biomaterial resulting from a sophi sticated manufacturing

process consisting of a purified agarose gel (polysaccharide), derived

from the purification of Agar-Agar processed from red algae. Totally

biocompatible to the human body and absorbable, Algeness®, does not

contain cross-linked synthetic chemicals (BBDE or PEG) associated with

Hyaluronic acid (HA) fillers and thus is 100% natural. The molecular and

biophysical properties of Algeness® make it a breakthrough in the filler’s

injection technology. For the first time in aesthetic medicine history, a 100%

natural, biodegradable and mouldable filler is available to the aesthetic market

for a more defined youthful look.

Algeness® agarose gel structure

Agarose is an hydrocolloid

molecule containing water in its structure

Page 3: VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and absorbable, Algeness®, does not contain cross-linked synthetic chemicals (BBDE or PEG)

(1) i filler di gel di agarosio: studio istologico di biocompatibilita’ e interazione con le strutture cutanee umane. prof. alessio pirino, dr. giorgio maullu. dipartimento

di scienze biomediche, università di sassari (2) safety and efficacy of algeness® vs juvederm to treat the nasolabial fold. double-blind study giovanni montealegre

gómez m.d. plastic surgeon and microsurgeon. national university of colombia, bogotá. colombia

W H A T I S T H E S C I E N C E B E H I N D

A L G E N E S S ® A L L N A T U R A L B I O D E G R A D A B L E I M P L A N T ?

Algeness® is the culmination of 10 years of

scientific and clinical research to find the most

natural, biocompatible material to fill wrinkles

and compensate for volume loss in facial soft

tissues. Extensive research has been conducted

to master the correlation of the agarose struc-

ture and the physiological response; in fact,

utilizing different concentrations of agarose, it

was possible to obtain various three dimensio-

nal structures that interact differently with the

vital and functional parameters of the cell.

Agarose which is h ighly purified is free of any

protein, a source for most bacteria, making it

highly biocompatible. Formulations of agarose

form stable gels with small amounts of mate-

rial (1% of agarose and 99% saline water) and

does not require any added chemicals for cross

linking. Chemically, agarose is a polysaccharide

Being free from toxicity to micro-organisms

and free from impurities, Algeness® is well to-

lerated within the human body. This produc-

tion process is only achieved by a limited nu-

mber of highly specialized facilities. They have

the rights to international patents to produce

highly purified, high quality agarose under rigid

physical-chemical, and bacteriological controls,

as well as quality standards of ISO 13485 and

ISO 9001.

A L G E N E S S ® F I L L E R S D E P T H O F I N J E C T I O N

W H A T A R E T H E B E N E F I T S O F A L G E N E S S ®

A L L N A T U R A L V O L U M I Z I N G B I O D E G R A D A B L E I M P L A N T ?

n Hydrocolloid gel 100% biocompatible

and biodegradable(1).

n Immediate volumizing: “What you see

is what you get” The physician and the

patient can see and evaluate the result

of the injection immediately after the

procedure.

n No need to wait to see the hydrophi-

lic reaction associated with all HA fillers

that can take 2-4 weeks for the full

effect to be realized.

n Free of solvents and chemicals; all

natural.

n Long lasting results remaining over

12 months proven by clinical studies(2).

n Non allergenic; Algeness® offers ex-

cellent tolerability and biocompatibility

with a negligible immunological reaction(1).

n Minimal irritation & inflammation

due to the absence of foreign body

reactions(1).

n Extremely low migration, the product

stays where it has been injected with

excellent persistence.

2,5%Agarose (High density)

Deep sub-dermal

3,5%Agarose (High density)

hypo-dermis and supra peri-osteal

SUPERFICIAL

HYPODERMIS

MUSCLE

DERMIS

DEEP

HYPODERMIS

BONE

1,5%Agarose (Low density)Sub-dermal

1%Agarose (Low density)Sub-dermal

Page 4: VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and absorbable, Algeness®, does not contain cross-linked synthetic chemicals (BBDE or PEG)

S C I E N T I F I C A N D C L I N I C A L R E S E A R C H

Currently there are several studies that were

published and there are a number of ongoing

and unpublished studies executed on the new

Algeness® injectable implant.

Wake Forest University in the United States

performed animal studies which were completed

in 2013 and 2014 with the 2.5% Algeness VL

and the 3.5% Algeness DF compared to HA

fillers. The Wake Forest comparative study

showed that after 6 months 2.5% and 3.5%

performed better compared to the other fillers,

showing Algeness® lasted longer, did not show

unpredictable changes due to inflammatory

reactions or water absorption, and exhibited less

migration.

Four clinical studies were conducted in Italy

and Denmark in 2006/2007 where Algeness®

performed well with minimal side effects and

no complication were reported. These studies

demonstrated the safety and efficacy of

Algeness® fillers.

Dr. Giovanni Montealegre, Professor of Plastic

Surgery at the National University of Colombia,

in Bogota, completed a 50 subjects study to

evaluate the safety and efficacy of Algeness® for

the correction of nasolabial folds in comparison

to Juvederm®. Both Juvederm® and Algeness®

have similar and comparable effects on safety

and duration. Algeness® offers excellent

tolerability and biocompatibility, is safe, natural

and has a negligible immunological reaction.

Over the first six months of observations, the

results are comparable with Juvederm®.

In 2017, a histological study to evaluate the

biocompatibility and the interactions between

Algeness Agarose Gel and human skin tissues

utilizing skin biopsies taken from human

volunteers has been conducted by Prof. Alessio

Pirino and Dr. Giorgio Maullu in the department

of biomedical science at the University of Sassari

(Italy). The study demonstrates a homogeneous

integration of the filler into the hypodermis, with

a minimal physiological inflammatory reaction

and no granulomatous activity, accompanied by

an increase in collagen formation.

In 2018 a 30 subjects study of the volumizing

effects of Algeness® and Voluma™ will

commence in Belgium with Dr. Joan Vandeputte,

in Italy, Dr. Giovanni Salti, and in Germany with

Dr. Tatjana Pavicic.

Also started other studies in process. Please

visit Algeness website www.algeness.com to

download studies

Dr. Ömer Buhsem Dr. Arna Shab Dr. Ömer Buhsem Dr. Joan Vandeputte Dr. Giorgio Maullu

Page 5: VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and absorbable, Algeness®, does not contain cross-linked synthetic chemicals (BBDE or PEG)

T H E U L T I M A T E T E C H N I Q U E T O M A S T E R Y O U R R E S U L T S ®

A R E A S O F A P P L I C A T I O N

ALGENESS® LD 1%

Indications

n Tear trough

n Lips

Depth of injection:

subdermal

ALGENESS® HD 1.5%

Indications

n Marionette lines,

n wrinkles and furrows

n Lip augmentation

and contouring

n Oral commissure

n Oro-mandibular folds

Depth of injection:

subdermal

ALGENESS® VL 2.5%

Indications

n Medium-deep volumizing

n Wrinkles, furrows and folds

n Cheeks, jawline and chin

n Nasolabial folds temple

n Non-surgical rhinoplasty

Depth of injection:

supra-periosteal

Subcutaneous

ALGENESS® DF 3.5%

Indications

n Deep volumetric filling

n Cheeks, jawline and chin

n Malar-zygomatic arch

n Submalar

Depth of injection:

Subcutaneous

Supraperiosteal

MASTER YOUR RESULTS®

N AT U R A L Y O U T H F U L L O O K

W I T H I M M E D I AT E R E S U LT S

Product

Composition 1% Agarose (Very low density)99% sterile saline

1.5 % Agarose (Low density)98 .5% sterile saline

2.5% Agarose (High density)0.5% non crossed-linked HA97% sterile saline

3.5% Agarose (High density)0.4% non crossed-linked HA96.1% sterile saline

Indication Tear troughLips augmentation and contouring

Marionette lines, wrinkles, and furrowsLip augmentationand contouringOral commissureOro-mandibular folds

Medium-deep volumizingWrinkles, furrows and folds Cheeks, jawline and chin Nasolabial foldsMalar and SubmalarNon-surgical rhinoplasty

Deep volumetric fillingCheeks , jawline and chinNasolabial foldsMalar-zygomatic archSubmalarNon surgical nose rhinoplasty

Technique Linear,Retrograde

Linear,Retrograde

Linear,Retrograde

Linear,Retrograde

Injection depth

Immediately Subcutaneous

Immediately Subcutaneous

Subcutaneous Deep soft tissue supra-periosteal

Follow up After 7-10 days if additional corrections are required

After 7-10 days if additional corrections are required

After 7-10 days if additional corrections are required

After 7-10 days if additional corrections are required

Duration 3 – 4 months or more 4 – 8 months or more 8 – 12 months or more 10 – 15 months or more

Volume 1.4 ml 1.4 ml 1.4 ml 1.4 ml

Needle size 30 G 30 G 27G 27G

Each boxcontains

2 disposable “full-use” 1.4 ml double Luer Lock syringe systems, 2 needles per syringe.

2 disposable “full-use” 1.4 ml double Luer Lock syringe systems, 2 needles per syringe.

2 disposable “full-use” 1.4 ml double Luer Lock syringe systems, 2 needles per syringe.

2 disposable “full-use” 1.4 ml double Luer Lock syringe systems, 2 needles per syringe.

Shelf life 2 years 2 years 2 years 2 years

LD1%

CharmHD

1,5%VL

2,5%DF

3,5%

IMMEDIATE VOLUMIZING:

[ WHAT YOU SEE

IS WHAT YOU GET ]

THE PHYSICIAN

AND THE PATIENT

CAN SEE AND EVALUATE

THE RESULT

OF THE INJECTION

IMMEDIATELY

AFTER THE PROCEDURE.

HYDROCOLLOID GEL

BIOCOMPATIBLE

AND BIODEGRADABLE.

100%

Page 6: VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and absorbable, Algeness®, does not contain cross-linked synthetic chemicals (BBDE or PEG)

Q&AQ. What is the difference with

other fillers?

A. Unlike all other fillers,

Ageness® is 100% natural and

biodegradable. Algeness®

achieves its volumizing youth-

ful effects without the require-

ment of any added chemicals,

solvents or cross-linked agents

and is completely and safely

absorbed over time by the bo-

dy’s natural mechanisms.

Q. What areas could be proble-

matic using Algeness®?

A. Never inject Algeness® su-

perficially. It is strongly recom-

mended not to use Algeness®

fillers in the dermis.

Q. Into which layers of the

skin is it possible to inject

Algeness®?

A. The higher concentration

Algeness® biodegradable

implant should be injected

deeply and never superficially.

We therefore suggest that the

Algeness® VL and Algeness®

DF only be used in the subder-

mal, subcutaneous or suprape-

riosteal spaces.

Q. Is there a difference in the

injecting technique between

Algeness® and HA?

A. There is a slight difference

in the injectability of HA versus

Algeness® due to the difference

in density of the material and

the depth of the injection.

Algeness® is injected deeply

and slowly. A thorough mas-

sage is performed to shape the

product, avoid formation of

lumps and obtain the desired

immediate result.

Q. Is it possible to inject Alge-

ness® in an area where other

filler was injected previously?

A. We see no reason why

Algeness® cannot be used in

an area where other injectables

have been injected. Howe-

ver, this needs to be studied

further.

Q. Is it painful?

A. All injections cause a sense

of pain; however, the physician

may decide to apply anesthetic

cream to the injection site to

numb the area.

Q. What kind of result can the

patient expect?

A. Algeness® subcutaneous fil-

ler is able to achieve a youthful

and natural look by filling-out

lines around the mouth, the

naso-labial fold as well as chin

augmentation, correction of

nose imperfections and rede-

sign the jaw line. It can also

re-plump your lips and add

volume and lift to your cheeks.

Q. How long will it last?

A. Algeness® corrective effects

typically last for about 12 mon-

ths or longer depending on the

injection amount and depth of

injection.

Q. What are the side effects?

A. Depending on the area

injected, the procedure is

relatively painless, although

there may be some mild dis-

comfort during treatments to

the sensitive nose or lip areas.

There may be some redness

around the site of injection for

1-2 days. Thanks to its unique

all natural bio-compatibility,

post-treatment allergic reac-

tions are minimized.

Q. What is the recovery time?

A. Treatment times may vary

from 20-25 minutes, depen-

ding on the correction level

requested by the patient. The

recovery time can be from

a few hours to several days

depending on the area treated.

Usually, patients receiving

Algeness® treatments return to

normal activities straight after

injection.

Q. What is the difference

between Algeness and other

HA fillers?

A. Algeness is the only all-na-

tural gel implant. No HA filler

is all natural, they all contain

chemicals for the cross-linkage

that the body does not absorb.

So it builds up creating latent

complications that is underre-

ported by the manufacturers.

Algeness does not have che-

micals and therefore does not

have this type of complication.

THE ALGENESS® UNIVERSE

B R O C H U R E

C A M P A I G N B T O C A D V E R T I S I N G D I G I T A L & P R I N T

P O S T E R S

N E W S L E T T E R T R A I N I N G

M A N U A L

S P E C I A L A L G E N E S S

Y O U T U B E C H A N N E L

P R E S E N C E O N S O C I A L

N E T W O R K S

T R A I N I N G M A N U A L O N L I N E

P A T I E N T

B R O C H U R E

A L G E N E S S P H O T O A P PW E B S I T E

••

••

F I L L E R O N T H E C U T T I N G E D G E

O F S C I E N C E

M A S T E R YO U R R E S U LT S T M

V O L U M I Z I N G

WHAT YOU S EE IS WHAT YOU GET

M A S T E R YO U R R E S U LT S T M

••

••

W Y S I W YG & 1 0 0 % N AT U R A L

R E S U LT

WHAT YOU S EE IS WHAT YOU GET

••

••

M A S T E R YO U R R E S U LT S T M

YO U R R E S U LT S T M

M A S T E R

WHAT YOU S EE IS WHAT YOU GET

••

••

M A S T E R YO U R R E S U LT S T M

WHAT YOU S EE IS WHAT YOU GET

A G A R O S E M O L E C U L A R

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R E D E S I G NYO U R B E A U T Y

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••

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M A S T E R YO U R R E S U LT S T M

WHAT YOU S EE IS WHAT YOU GET

YO U T H F U L L O O K

W I T H I M M E D I AT E R E S U LT S

U N I Q U E

Page 7: VOLUMIZING BIODEGRADABLE INJECTABLE IMPLANT ON THE … · biocompatible to the human body and absorbable, Algeness®, does not contain cross-linked synthetic chemicals (BBDE or PEG)

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