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Page 1: INTRODUCTION - Algeness · 2019. 3. 2. · INTRODUCTION While the demand for minimally invasive procedure treatments increases, the fillers market is facing the publication of concer-
Page 2: INTRODUCTION - Algeness · 2019. 3. 2. · INTRODUCTION While the demand for minimally invasive procedure treatments increases, the fillers market is facing the publication of concer-

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 facing the publication of concer-

ning reports of immediate or late reactions

to Hyaluronic Acid (HA) fillers or other che-

mically based filling substances. The pa-

tients and the scientific community itself are

trending to natural and biocompatible der-

mal fillers as a safe and effective solution to

avoid adverse outcomes.

In response to the physician and patient

need, 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 scien-

tific 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 Agar­Agar processed

from red algae. Totally biocompatible to the

human body and absorbable, Algeness®, does not

contain cross­linked 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 water is contained in its structure

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

OH

OH HOn

H OO

OO

O

OH

OH

Page 3: INTRODUCTION - Algeness · 2019. 3. 2. · INTRODUCTION While the demand for minimally invasive procedure treatments increases, the fillers market is facing the publication of concer-

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 interacted differently with

the vital and functional parameters of the cell.

Algeness® agarose is derived from the purifica-

tion of Agar-Agar, which in turn is derived from

red algae of the genus of gelidium.

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 material

(1% of agarose and 99% saline water making the

product able to be shaped for a more defined

natural look.

Chemically, agarose is a polysaccharide of a long

chain of disaccharide units formed by two rings

of 6 atoms. On each ring there is one oxygen and

5 Carbon atoms and only one OH group.

The agarose, being chemically inert does not

bind ions and does not precipitate when injec-

ted subcutaneously. Being free from toxicity to

micro-organisms and free from impurities, Alge-

ness® is well tolerated within the human body.

This production process is only achieved by a

limited number of highly specialized facilities.

They have the rights to international patents to

produce highly purified, high quality agarose

under rigid physical-chemical, and bacteriolo-

gical controls, as well as quality standards of

ISO 13485 and ISO 9001

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

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.

n Non allergenic; Algeness® offers ex-

cellent tolerability and biocompatibility

with a negligible immunological reaction.

n Minimal irritation & inflammation

due to the absence of foreign body

reactions

n Extremely low migration, the product

stays where it has been injected with

excellent persistence.

A L G E N E S S ® : A C O M P L E T E R A N G E O F 1 0 0 %

N A T U R A L F I L L E R S F O R F A C E R E J U V E N A T I O N

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

OH

OH HOn

H OO

OO

O

OH

OH

••

ALGENESS® LD 1%

Indications

Tear trough

Lips

Depth of injection:

subdermal

ALGENESS® HD 1.5%

Indications

Marionette lines,

wrinkles and furrows

Lip augmentation

and contouring

Oral commissure

Oro-mandibular folds

Depth of injection:

subdermal

ALGENESS® VL 2.5%

Indications

Medium-deep volumizing

Wrinkles, furrows and folds

Cheeks, jawline and chin

Nasolabial folds

Non-surgical rhinoplasty

Depth of injection:

Subdermal

Subcutaneous

ALGENESS® DF 3.5%

Indications

Deep volumetric filling

Cheeks, jawline and chin

Malar-zygomatic arch

Submalar

Depth of injection:

Subcutaneous

Supraperiosteal

Agarose (High density)

Deep sub-dermal Agarose (High density)

hypo-dermis and supra peri-osteal

S U P E R F I C I A LH Y P O D E R M I S

M U S C L E

D E R M I S

D E E P H Y P O D E R M I S

B O N E

3,5%

2,5% Agarose (Low density)Sub-dermal

1,5%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

1% Agarose (Low density)Sub-dermal

Page 4: INTRODUCTION - Algeness · 2019. 3. 2. · INTRODUCTION While the demand for minimally invasive procedure treatments increases, the fillers market is facing the publication of concer-

A L G E N E S S ® S C I E N T I F I C R E S E A R C H

Currently there are 3 studies that were published

and there are a number of unpublished studies

executed on the new Algeness® 3.5% DF.

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 Restylane, Juvederm and

Radiesse. 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 serious problems were

reported. The effects of Algeness® lasted a

minimum of 6 months but was not compared

directly to Restylane or other filler materials.

These studies demonstrated the safety and

efficacy of Algeness® fillers. Algeness® HD

was extensively studied in the lips and was

found to be very effective with no reports of

adverse reactions.

Dr. Giovanni Montealegre, Professor of

Plastic Surgery at the National University of

Colombia, in Bogota, completed a 50 subject

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 2016 a 30 subject 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 in 2016, is a prospective,

randomized, within-subject controlled study

of the effectiveness and safety of Algeness®

VL 2,5% Natural Agarose Subdermal Filler

Injectable Gel versus Restylane Perlane™

Injectable Gel, for the correction of moderate

and severe nasolabial folds. The principal

investigator is Nicolo Scuderi, MD, Professor

at University of Rome.

Page 5: INTRODUCTION - Algeness · 2019. 3. 2. · INTRODUCTION While the demand for minimally invasive procedure treatments increases, the fillers market is facing the publication of concer-

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 periorbital area.

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

VL and DF only be used in the

subdermal, subcutaneous or

supraperiosteal 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 mold the

product, avoid formation of

lumps and obtain the desired

immediate result.

Q. Is it possible to inject

Algeness® in an area where

Radiesse (or a similar 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 na-

so-labial fold as well as crow’s

feet and forehead wrinkles. 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.

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

OH

OH HOn

H OO

OO

O

OH

OH

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: INTRODUCTION - Algeness · 2019. 3. 2. · INTRODUCTION While the demand for minimally invasive procedure treatments increases, the fillers market is facing the publication of concer-

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