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Profhilo Brochure

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IBSA GROUP IBSA DERMA

Founded by a group of Swiss biologists in 1945, OVER 25 OFFICES & The IBSA Derma approach is aimed at countering
MANUFACTURING
IBSA - Institute Biochemical SA - has gained PLANTS
the physiological decrease of hyaluronic acid in the skin
unique experience in pharmaceutical research tissue, thus restoring hydration, elasticity and tone.
and technology. In fact, in a synergistic way, it combines deep hydration
IBSA has used its experience and expertise in with mechanical action of lifting the skin.
the pharmaceutical field to branch out and
HUNDREDS OF
develop medical devices for dermatology PRODUCTS COVERING Thanks to its innovative use of ultrapure hyaluronic acid,
based on hyaluronic acid - thus creating a 10 THERAPEUTIC AREAS we can now say that IBSA Derma has redefined
dedicated dermoaesthetic brand: IBSA Derma. the canons of classical beauty.
IBSA Derma distinguishes itself in this vast
market because it controls the entire product In fact, throughout history, beauty has had well-defined
lifecycle, from the biofermentation production PRODUCTS AVAILABLE and specific standards. Today this is no longer the case,
of the raw material to the ready-to-use final IN MORE THAN 80 because IBSA Derma has redefined the beauty rules
COUNTRIES
product in pre-filled syringes. while enhancing the authenticity of each individual.

EVERYONE IS
A MASTERPIECE
“I firmly believe that the primary role
of our company is to focus on the
needs of patients and healthcare
professionals, through the work
of a well-trained, and above all,
IBSA Derma brings out the authentic beauty
satisfied and motivated group.”
in everyone, proving that we are all masterpieces.
No more faces that look the same and procedures
that may distort the somatic traits, now real people
are the only reference of beauty that counts.

Arturo Licenziati

President & CEO - IBSA GROUP


for
W H AT I S
BIOREMODELING
Stabilised Hybrid Cooperative Complexes (HCC) of high and low
molecular weight Ultrapure Hyaluronic Acid in high concentration,
produced with a unique NAHYCO® Hybrid Technology and innovative
thermal production process patented by IBSA, the NAHYCO®
Technology.

INTENDED USE
PROFHILO® is a new multi-level bioremodeling injectable
treatment indicated for contour redefinition and laxity
remodeling of the face.

FACE

PROFHILO®, acting through a corrective action of natural and induced


cutaneous depressions, intervenes:

EACH BOX CONTAINS: • in the physiological process of ageing tissue, the effects of which
include reduced skin hydration, the alteration of elastic fibers and
• 1 Pre-filled 2 ml syringe collagen of the dermis, with loss of turgor and skin tone;
• 1 Instructions for Use Leaflet (IFU)
• 1 Patient Information Leaflet (PIL)
• in the dermal tissue repair process, in cases of acne or scars.
• 1 Patient Insert Card (PIC)
• 2 Terumo needles 29G TW 13 mm
• 2 Product traceability stickers
PRODUCTION PROCESS

STEP 1 STEP 2 STEP 3 STEP 4


MOLECULES COMBINED RISING TEMPERATURE LOWERING TEMPERATURE A NEW MOLECULE

32 mg of hyaluronic acid According to IBSA’s patented The temperature is lowered, Stabilised hybrid
high molecular weight thermal production process, the causing the hydrogen bonds cooperative complexes
(1100-1400 kDa) mix is heated, causing the weak to form between the H-HA and are obtained.
+ hydrogen bonds (which connect L-HA molecules, thus creating
32 mg of hyaluronic acid H-HA molecules) to break. and stabilising the hybrid
low molecular weight cooperative complexes.
(80-100 kDa)

NO chemical cross-linking agents used1 NO chemical cross-linking agents used1


PROPERTIES & SAFETY PROFILE EXTENSIVE SPREADABILITY3 AND LOW VISCOSITY2
PROFHILO®’s rheological properties feature a predominance of fluidity over
elasticity (tan delta > 1) which is not present in cross-linked gels.

HIGH HA CONCENTRATION (64mg/2ml)1


The highest on the market*. PROFHILO® FLOWABILITY EVIDENCE BASED PERSPECTIVE3
Notable for its ability to flow uniformly through entire anatomic units after injection and
therefore homogenously expanding fat compartments in challenging areas where even
low viscosity fillers can produce contour irregularities.

HIGH QUALITY HA
IBSA’S hyaluronic acid is a Shyalt Ultrapure
grade HA, produced through a patented
biofermentation process of Streptococcus
Zooepidemicus.

2 3

BIOCOMPATIBILITY & 4 5

TOLERABILITY
Thanks to NAHYCO® technology it is 100% 5 BAP injection sites on each side of the face. 3D image taken 15 minutes after
This image is for illustrative purposes only and is intended to convey PROFHILO® BAP face treatment
free of chemical stabilising agents and it the concept and vision of the PROFHILO® BAP technique. Do not
use this image as a sole reference to perform the treatment.
presents exceptional biocompatibility and
• Visualisation of volume changes
tolerability2.
using a colour code in the
QuantifiCare software suite.
• Yellow indicates a positive change
in volume from the 3D photo
DEGRADATION PROCESS
taken before treatment, confirming
Hybrid Cooperative Complexes (HCC) of
PROFHILO®’s spreadability.
Hyaluronic Acid are biodegradable and
• Red indicates greater volume
bioresorbable by the body.
change in the points injected
towards the end of the treatment.

* Survey carried out by IBSA


PROPERTIES & SAFETY PROFILE HOW IT WORKS

PROFHILO® PROMOTES MULTI-LEVEL REMODELING.


It plays a role inside the extracellular matrix, creating the physiological
conditions for the proliferation, migration and organisation of the
dermal cellular component:

FIBROBLASTS KERATINOCYTES ADIPOCYTES


HIGH COHESIVITY AND TISSUE INTEGRATION3
An important characteristic owing to the high cohesivity of PROFHILO®
is its tissue integration capacity. Notable for its ability to flow uniformly EPIDERMIS
through entire anatomic units after injection and therefore homogeneously
DERMIS
expanding.
HYPODERMIS

LEADING MANUFACTURERS
IBSA distinguishes itself because it controls the entire product life cycle, from
the bio-fermentation production of the raw material to the ready-to-use
pre-filled HA syringes.

The intradermal administration of PROFHILO® allows an optimal quantity


of HA to be brought directly to the tissue being treated, in order to
counteract the cytotoxic action of free radicals on the fibroblasts and
on the adipose compartments below, aiding in the effectiveness of
preventatitve and corrective aesthetic medicine treatments.
HOW IT WORKS “IN VITRO”
KERATINOCYTES-FIBROBLASTS:
PROFHILO® INCREASES
ELASTIN EXPRESSION.
Control PROFHILO® 0.1% High molecular weight HA 0.1% Low molecular weight HA 0.1%

In vitro keratinocytes-fibroblasts immunofluorescence


pictures relative to elastin expression1

Elastin

ADIPOCYTES:
PROFHILO®
SUPPORTS VIABILITY.
Commercially available
Control PROFHILO® 0.5% High molecular weight HA 0.5% cross-linked HA dermal filler 0.5%

MULTI-LEVEL DYNAMIC REMODELING

In vitro studies have shown that PROFHILO® improves


the extracellular environment, providing potential mechanisms In vitro Oil Red O staining performed on Adipocyte Stem Cells
for its aesthetic effects:1-2 in adipogenic medium, 14 days after incubation2

• Maintaining suitable conditions for the viability Fat deposits Courtesy of Bioteknet

of fibroblasts, keratinocytes and adipocytes

• Leading to a remodeling of the extracellular matrix


in terms of elasticity and support
HOW TO USE

An initial cycle of TWO TREATMENT SESSIONS WITH A 30-DAY


INTERVAL is recommended, followed if necessary by maintenance
treatments.
However, it is suggested to evaluate the specific PROFHILO® protocol
according to the patient’s degree of ageing*.

THE

BAP TECHNIQUES
(BIO AESTHETIC POINTS)

Originally created for the malar and sub-malar areas due to their
predisposition to dermal atrophy caused by the ageing phenomena,
the BAP Technique is the most widespread and highly recommended
protocol for treating these areas4-7.

Owing to PROFHILO®’s high flowability, without leaving tissue


irregularities, a specific BAP Technique was developed for the face.

* Number of treatments and product quantity depend on the degree of ageing.


REMODELING THE

MALAR &
SUBMALAR AREAS

These 5 points identify the 5 anatomically receptive


areas of the face with an absence of large vessels and
nerve branches, therefore, minimising the risks while
maximising the diffusion of the product in the malar
and submalar areas.

Identify the 5 BAP Inject 0.2 ml per


injection sites on each bolus at the superficial
side of the face subcutaneous layer

1
1 PERI-ORBITAL MALAR REGION
at least 2 cm away from the external corner of the eye

2 ZYGOMATIC ANTERIOR PROTUSION 2


3
• draw a line connecting the nostril and tragus
• draw a perpendicular line starting from the pupil
• locate the injection point at the intersection of the 2 lines

3 TRAGUS 5
1 cm anterior to the bottom of the tragus

4 CHIN
• draw a vertical line in the center of the chin 4
• draw a perpendicular line one third from the top of the vertical line
• from the point of intersection move 1.5 cm towards the oral commissures

5 MANDIBULAR ANGLE
1 cm above the mandibular angle
This image is for illustrative purposes only and is intended to convey the concept and vision of the Profhilo BAP Technique.
Do not use this image as a sole reference to perform the treatment.
RESULTS
Improved hydration and elasticity7 High satisfaction of doctors and patients6

100
4
Right side
90
Left side 3,5
patients’ Evaluation on 30 female patients
assessment
80 treated using BAP technique
* *
Skin Hydration (%)

70 3
1st evaluator’s
Average age 53 yrs
60
2,5 (Range 40-68 yrs)

GAIS Score
assessment
50
Evaluation on 15 female 2
40 patients treated using
2nd evaluator’s
Significant
30 BAP technique 1,5 assessment improvement of
20 1 satisfaction levels after
Average age 53 yrs
10
(Range 39-65 yrs) 0,5
the second treatment
0
Baseline T4W T8W 0
4 weeks after 4 weeks after *p value <0.05
1st treatment 2nd treatment 4 weeks after 4 weeks after
1st treatment 2nd treatment

100
Significant improvement
in skin hydration after
*
90
only one treatment
Skin Viscoelasticity (Uv/Ue)

80

70 and in skin elasticity after


60 two treatments
50

CONCLUSIONS
40

30

20

10
0
Baseline T4W
4 weeks after
T8W
4 weeks after PROFHILO® shows a significant improvement of the skin parameters and a
1st treatment 2nd treatment
noticeable aesthetic outcome3.

PROFHILO®’s tightening action


has a positive effect on facial volume4
Evaluation on 64 female patients
treated using BAP technique Based on these characterisations, PROFHILO® represents an intriguing new
100 Improved
90 83
No change Average age 53 yrs paradigm for skin restoration and improvement of skin laxity3.
80 70 Worsened (Range 38-60 yrs)
70 62
Subjects %

55
60 FVLS
50 38
45 (Facial Volume Loss Scale
40 range 2-3)
PROFHILO® has significant potential for synergistic combination with
30
30
17
20 70% of subjects
10 0 0 0 0 show an improvement conventionally cross-linked fillers to finesse volumetry results3.
of at least one grade
0
T4W T8W T12W T16W
4 weeks after 4 weeks after 8 weeks after 12 weeks after
1st treatment 2nd treatment 2nd treatment 2nd treatment according to the FVLS
BEFORE & AFTER

Courtesy of PRODUCT QUANTITY/NEEDLE 1 ml per side - 29G x 13mm


Dr. Elena Goltsova TREATMENT SESSION 2 treatments (1 month interval)
(Russia) FREQUENCY twice per year

Courtesy of PRODUCT QUANTITY/NEEDLE 1 ml per side - 29G x 13mm


Dr. Emma Ravichandran TREATMENT SESSION 2 treatments (1 month interval)
(Glasgow, Scotland) FREQUENCY twice per year
CLINICAL STUDIES MARKET APPROVAL

An increasing number of validated clinical studies, published in leading scientific journals. MORE THAN 4.3 MILLION TREATMENTS since 2015 8.
Currently present in more than 80 COUNTRIES.

IN VITRO In vitro analysis of the effects on wound healing of high and Full text available on
PubMed, PMID: 26163378
CLINICAL
low molecular weight chains of hyaluronan and their hybrid
H-HA/L-HA complexes.
STUDY
D’Agostino, et al.

Full text available on


Hyaluronan hybrid cooperative complexes as a novel frontier PubMed, PMID: 27723763
for cellular bioprocesses reactivation.
Stellavato, et al.

Full text available on


Hybrid Complexes of High and Low Molecular Weight
PubMed, PMID: 29179206
Hyaluronans Highly Enhance HASCs Differentiation:
Implication for Facial Bioremodeling.
Stellavato, et al.

BAP Efficacy, safety, and tolerance of a new injection technique Full text available on
PubMed, PMID: 26491508

CLINICAL
for high and low molecular weight hyaluronic acid hybrid
complexes.
STUDY
Laurino, et al.

Hyaluronic acid hybrid cooperative complexes and the


BAP (Bio Aesthetic Points) technique: the new edge in
biorejuvenation. Beatini, et al.

Efficacy and tolerance of an injectable medical device Full text available on


containing stable hybrid cooperative complexes of high and PubMed, PMID: 27713647
low molecular weight hyaluronic acid: a monocentric 16 weeks
open-label evaluation. Sparavigna, et al.

Hybrid cooperative complexes of high and low molecular


weight hyaluronans (Profhilo®): review of the literature and
presentation of the VisionHA project. Agolli, et al. AWARDS

SAFETY Safety Assessment of High- and Low-Molecular-Weight

ASSESSMENT
Hyaluronans (Profhilo®) as Derived from Worldwide
Postmarketing Data Cassuto, et al.
COMPOSITION
C O M P L E X O F H YA L U R O N I C A C I D S
HIGH MOLECULAR WEIGHT + LOW MOLECULAR WEIGHT

The high molecular weight protects the skin, restoring and


Multi-action antioxidant cream for maintaining cellular vitality.
preserving the integrity of the hydro-lipid film.
Face, neck and décolletage remodeling.
The low molecular weight helps to maintain optimal skin
Enhances firmness and elasticity and reduces micro-wrinkles.
hydration, thanks to its particular hydrophilic characteristics.

H A E N K E N I U M®
PATENTED DRY EXTRACT OF SALVIA HAENKEI

It slows down the degradation of hyaluronic acid, caused by


free radicals, and thus prolongs its beneficial action on the skin.

It acts as a screen for free radicals, which cause oxidative stress


and premature cellular senescence (Salvia haenkei acts as a
gero-suppressant, reducing cellular senescence by 50%9).

INTENDED USE
FACE NECK DÉCOLLETAGE

P R O T E C T S the skin from premature ageing caused by


oxidative stress factors, pollution, excess exposure to UV rays,
poor diet, smoking etc.).

R E S T O R E S the protective barrier of sensitive and


stressed skin which is irritated and red due to oxidative stress
CONTENTS OF THE PACK: or following dermoaesthetic treatments.

• 1 Airless bottle I M P R O V E S skin quality such as small wrinkles and the


• 50 ml of antioxidant cream loss of firmness and elasticity.
VISIBLE WRINKLE DEPTH REDUCTION
IN THE PERIOCULAR AREA
Baseline or T0
21

Length (mm)
18

15
CLINICAL STUDIES ON
12

FACE NECK DÉCOLLETAGE


9

Thanks to its combination of hyaluronic acid and HAENKENIUM®, visible signs of 6

ageing, such as wrinkles, diminish while restoring skin firmness and elasticity.
3

0
0 5 10 15 20 25 30 35

Width (mm)

RESULTS10-11 AFTER TWO WEEKS 21


84 days

Length (mm)
An INCREASE of more than 40% of NATURAL CELLULAR ANTIOXIDANT ACTIVITY 18
and a REDUCTION in the SIGNS OF PHOTOAGEING caused by oxidative stress.
15

12
A statistically significant IMPROVEMENT IN ELASTICITY.
9

6
A REDUCTION IN WRINKLE DEPTH of ~10% that reaches ~30%
after three months of treatment. 3

0
0 5 10 15 20 25 30 35

Dermatologically tested on sensitive skin. Width (mm)

Height (µm)
-600 -400 -200 0 200 400 600

Images taken with Canfield Primos 3D. Blue color indicates greater wrinkle depth.
References

Material intended for medical practitioner’s use only


1) PROFHILO® Instructions for Use leaflet.
2) D’Agostino A. et al. 2015; BMC Cell Biol 16:19.
3) Sundaram H. et al. 2016; Poster Presentation,
American Society for Dermatologic Surgery (ASDS)
Annual Meeting.
4) Sparavigna A. et al. 2016; Clin Cosmet Investig
Dermatol 9:297-305.
5) Laurino C. et al. 2015; Eplasty 15:e46.
6) Rodríguez Abascal M et al. 2015; Eur Aesth Plast
Surg J 2015; 5(2): 124-131.
7) Beatini A. et al. 2016; Aesthetic Medicine 2(2):45-51.
8) IBSA internal data on file YTD 05/2021.
9) Matic I. et al.: Identification of Salvia haenkei
as gerosuppressant agent by using an integrated
senescence screening assay. Aging 2016 - Vol. 8
December, pag 1-18.
10) Cestone E. et al.: Evaluation of the anti-ageing
efficacy of Hilow Haenkenium cream in healthy
woman. Aesthetic Medicine 2020 - Vol. 6; 1:25-33.
11) Cestone E. et al.: Determination of the anti-
ageing efficacy of Profhilo Haenkenium cream in
healthy subjects on neck and decollettè. (submitted).

PRO-BRM-001-2021-E
To learn more about PROFHILO® go to www.ibsaderma.com.au

PRESCRIPTION ONLY MEDICAL DEVICE. BEFORE PRESCRIBING PLEASE REVIEW


APPROVED INSTRUCTIONS FOR USE.

19200
ARTG ENTRY 387132. Made in Italy. PROFHILO® is a registered trademark of IBSA. IBSA
Farmaceutici Italia S.r.l Via Martiri di Cefalonia 2 26900 Lodi – Italy. Distributed in Australia
and New Zealand by Dermocosmètica ABN 52 152 881 019. Unit 8, 14–16 Lens Street,
North Coburg VIC 3058, Australia
T: +61 3 9354 0898 F: +61 3 8692 6923 E: info@dermocosmetica.com.au

profhilo_aunz dermocosmetica_au

Web: ibsaderma.com.au dermocosmetica.com.au

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