Physician Brochure

PROLLENIUM MEDICAL TECHNOLOGIES INC.
TEL: 905 508 1469
WWW.REVANESSE.COM
138 INDUSTRIAL PARKWAY N, AURORA, ON
TOLL FREE: 1 866 353 3015
WWW.PROLLENIUM.COM
L4G 4C3 CANADA
EMAIL: [email protected]
Cross-Linked Hyaluronic Acid
PN99022 RV02
Revitalize
Rejuvenate
ReNew
®
The
Revanesse
Family of
Products
The Revanesse family is a collection of injectable
dermal fillers that are used to treat signs of aging.
The products have been developed to smooth
out lines and wrinkles, shape and contour facial
features and add volume, creating a more
youthful look.
Now with Lidocaine +
The Revanesse line of products is now available
with Lidocaine (0.3%) for added patient comfort.
The Revanesse line incorporates Thixofix® crosslinking technology, resulting in high quality, safe
and long-lasting dermal fillers. The products are
biodegradable and non-animal, using the highest
concentration of hyaluronic acid (HA) available
in addition to the rejuvenating properties of non
cross-linked HA.
Revanesse Contour, ReDexis and products containing lidocaine are not yet available for sale in the EU.
Prollenium products are not yet available for sale in the US.
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Revanesse Pure is the only non cross-linked HA gel in the Revanesse family of dermal fillers.
Pure helps to nourish and moisturize the entire surface of the skin as it is quickly absorbed. The gel
replenishes HA lost to aging while hydrating the skin and restoring elasticity for firm, healthy looking
skin.
Revanesse is a lower viscosity filler best used to fill in superficial imperfections in the dermis. The ultra
smooth HA gel makes it easy to inject into the skin. Revanesse can be used for emerging/fine lines,
perioral lines, crow’s feet/periorbital lines, tear troughs and glabellar lines.
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Revanesse Ultra is a high viscosity, long-lasting gel used to treat deep and more pronounced lines.
Ultra can be used to treat nasolabial folds, marionette lines, deep wrinkles and folds and enhance
mid-face volumization.
Revanesse Kiss has been specifically engineered for lip augmentation and definition. The unique
properties of the lips require a specially formulated filler to ensure ideal post-injection results. The
result of this special design is a filler which is easy to inject and mold with fewer incidences of swelling.
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Revanesse Contour is a fully absorbable, ultra-high viscosity HA gel specially formulated for facial
contouring and shaping. The gel is ideal for large volume treatments and can be used for mid-face
volumization, chin and jaw augmentation and nose bridge correction.
The HA gel in ReDexis has a unique ingredient - dextranomer beads - which supports the body’s generation
of new tissue. These fully absorbable dextranomer beads create a scaffolding effect for collagen growth.
ReDexis provides natural augmentation, which lasts even after the HA has been broken down. It can be
used to treat deep wrinkles, folds and facial lipoatrophy.
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The
Science
Behind...
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Thixofix®
Other HA Fillers
Thixofix ® Technology
• Large amounts of dangling and ineffective
internal links
• Require more BDDE
• Leads to higher incidences of adverse reactions
and decreased durability in skin
• Requires less BDDE as dangling and ineffective
links are minimized
• Results in a safe, long-lasting product
CROSS-LINKING TECHNOLOGY
The Revanesse line of dermal fillers uses a unique formula and proprietary Thixofix cross-linking
technology. This technology allows a highly viscous gel to be easily injected through a fine
gauge needle without causing degradation to the modified HA particles. Returning to its
viscous state, the gel provides a soft, smooth feel to the skin once it is injected.
In order to be durable in the skin, HA must go through a bonding process called cross-linking
since unmodified HA will quickly break down in the body. Prollenium’s cross-linking process is
designed to maximize the effectiveness of the cross-linked HA chains present in the gel. Links
between different HA polymer chains are promoted, while ineffective 'dangling' links and less
effective links between portions of the same chain are minimized. The result is a durable gel
with a minimal amount of BDDE leading to fewer incidences of post-injection complications
such as swelling.
The gel is balanced to be compatible with the fluid in the skin, neither drawing in nor releasing
water. This minimizes problems of overfilling or the need for volume correction. As the filler is
slowly degraded over time, the cross-linked network is loosened allowing for slow expansion of
the gel particles that partly offset the natural loss in dermal filler volume, maintaining the level
of correction.
Effective Links
Dangling (partially reacted) Links
Ineffective Internal Links
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Gel Characteristics
Revanesse ® Ultra
Restylane ®
Homogeneity
Prollenium’s proprietary Thixofix cross-linking and milling technology combine to produce the most
homogeneous HA gel available in the commercial filler market. This unique milling technology makes
the HA particles in Revanesse smaller and more uniform than competing products, creating a gel
that is easier to inject and mold. Additionally, these properties ensure that the gel will break down
more slowly and predictably allowing for more natural, long-lasting results.
1.5
2.0
2.5
Juvederm ® Ultra Plus/4
3.0
3.5
4.0
80
60
40
Percentage of Gel
0
20
80
60
40
Percentage of Gel
0
1.0
Juvederm ® Ultra Plus/4
20
60
40
0
20
Percentage of Gel
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Aspect Ratio Comparison
Aspect ratio is a measure of the sphericity of a particle. If the length of a particle equals the width
(i.e. is spherical), then the aspect ratio is equal to one.
1.0
1.5
2.0
2.5
3.0
3.5
4.0
Revanesse ® Ultra
1.0
1.5
2.0
2.5
3.0
3.5
4.0
Restylane ®
Uniformity
HA gel particles that are spherical and uniform are smoother and easier to inject, providing more
natural looking results. Revanesse products contain the most consistently uniform particles available,
allowing for optimal integration into the skin.
Juvederm® is a registered trademark of Allergan Inc.
Restylane® is a registered trademark of Galderma Inc.
Revanesse®, ReDexis® and Thixofix® are registered trademarks of Prollenium Medical Technologies Inc.
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Durability
Dextranomer Beads
One of the properties influencing the
durability of HA fillers is directly related to the
degree of cross-linking of the HA molecules.
The Revanesse line of fillers employs its
proprietary Thixofix technology, one of the
most advanced methods of cross-linking
available.
1
G'(t) / G'(0)
The degree of cross-linking in Thixofix is
optimized, slowing the natural rate of
degradation in the body. This allows for
long-lasting results while ensuring that
the body treats it like native HA reducing
the likelihood of adverse events such as
swelling. The Revanesse fillers exclusively
use HA with a high molecular weight to
achieve maximum durability and longevity.
The key ingredient in ReDexis - positively
charged dextranomer beads - is made of
biocompatible cross-linked glucose molecules. These beads attract negatively
charged GAG and elastin (soft tissue) to
the injection site which then begin to bind
together forming a scaffold of new collagen. This new collagen will stay at the injection site providing natural augmentation
long after the HA has been broken down
and absorbed. The end result is increased
volume to the injection site and a longer-lasting and more natural look than traditional fillers.
Enzymatic Degradation Data
Scaled G' (G' at time t divided by G' at time 0)
at 1 Hz as a function of time
0.1
Revanesse® Ultra
Juvederm® Ultra Plus/4
Restylane®
0.01
0
500
1000
Time / s
1500
2000
In vivo depiction of dextranomer beads.
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Ease of Injection
Safety
The greatest care has been taken to ensure that Revanesse dermal fillers are easy to inject. The
syringes have been designed to include extra wide finger flanges and broadened pistons that
provide much greater ease of use and flexibility when injecting.
Revanesse dermal fillers have been proven to be safe and effective. The line of fillers is completely
free of all animal products, reducing the risk of an immunogenic reaction. Revanesse products are
biocompatible and biodegradable breaking down naturally in the body.
The unique milling process results in an ultra-smooth gel that enables even the highly viscous
Revanesse Contour to be easily injected with fine gauge needles without compromising the integrity
of the gel.
The Revanesse family is produced in a state of the art manufacturing facility in Canada and every
aspect of the manufacturing process is controlled. Extensive tests are performed on all of the
raw materials used to produce Revanesse. Strict in-process controls are continuously used during
the manufacturing process and each batch is meticulously tested in-house against the strictest
of standards. As a final test each and every syringe is visually inspected ensuring that it is safe,
biocompatible and effective.
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Testing
The safety of the Revanesse family of products is Prollenium’s utmost concern. The following tests are
conducted:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Muscle implantation
Acute systemic injection
Biocompatibility and toxicity
Cytotoxicity
Guinea pig maximization sensitization
Identification: pH, osmolality, residual BDDE, sterility
Intracutaneous reactivity
Mutagenicity
Protein
Reverse mutation assay
Tests for interactions with blood Haemolysis
Tests for local effect after implantation
Acute toxicity
Subchronic toxicity
Full suite of ISO 10993 testing
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Product Outline
Indication
Stabilized HA
Composition
Treatment Areas
Revanesse® Pure
Revanesse®
Revanesse® Ultra
Revanesse® Kiss
Revanesse®
Contour
ReDexis®
Bio-Revitalization
Small to Medium
Lines & Wrinkles
Mid to Deep
Lines & Wrinkles
Lip
Augmentation
Subcutaneous
Volumetric
Contouring
Mid to Deep Lines
& Wrinkles
14mg/ml
Non Cross-Linked
25mg/ml
25mg/ml
25mg/ml
25mg/ml
25mg/ml
DEAE Sephadex
25mg/ml
1
2&3
4&5
3&4
5
Injection Depth
Epiderrmis
Degree of
Cross-Linking
-
***
****
***
*****
****
Dermis
Mid
30G or 32G
30G
27G
27G
Needle Used
Subcutaneous
Deep
Injection Depth*
Superficial Dermis
27G
27G
27G or 30G
27G
27G
Mid Dermis
Mid-Deep Dermis
-
Subcutaneous/
Periosteum
Subcutaneous
*Depth of injection is only provided as a suggestion. The administering physician should determine injection depth according to the severity of
the depression and the level of correction that is desired.
*Depth of injection is only provided as a suggestion.
The administering physician should determine injection depth
according to the severity of the depression and the level of
correction that is desired.
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Proven Results
"Revanesse has boosted my confidence drastically. I look and feel great,
and the best part is that no one can tell why."
Vicki, 48
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Before & After
Before
After
Cheeks, chin, temples and nasolabial folds treated with Revanesse Contour
Before
After
Nasolabial folds and marionette lines treated with Revanesse Ultra
Before
After
Facial asymmetry corrected with Revanesse Ultra
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Before & After
Before
After
Nasolabial folds treated with Revanesse Ultra
Before
After
Tear troughs and lips treated with Revanesse and Revanesse Kiss
Before
After
Lips volumized with Revanesse Kiss
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Before & After
Before
After
Facial asymmetry corrected with Revanesse Ultra
Before
After
Perioral lines and surrounding area treated with Revanesse and Revanesse Pure
Before
After
Cheeks and temples volumized with Revanesse Contour, nasolabial folds treated with Revanesse Ultra and lips
volumized with Revanesse Kiss
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Canadian-Made
BY PROLLENIUM MEDICAL TECHNOLOGIES INC.
MADE IN CANADA
The Revanesse family of dermal fillers is produced by Prollenium Medical Technologies Inc.- a
Canadian company located in Aurora, Ontario. Prollenium focuses its attention on the research,
production, marketing, and sales of novel biomaterials that can be used in tissue reconstruction.
Prollenium is highly committed to the research and development of safe and effective products.
“Our mission is to address clients’ needs through innovative products. A substantial share of our
revenue is invested in research and development into novel applications of new and existing
biomaterials. The goal is to ensure a steady flow of new products to the marketplace.”
Prollenium is proud to be the first and only dermal filler manufacturer in Canada. The facility employs
a fully automated process in a clean room environment with sterilization, packaging, quality control
and R&D taking place in-house. The facility is ISO 13485 registered as well as Health Canada and CE
approved.
Founded in 2002
The only HA dermal filler manufacturing facility in Canada
Used in over 80 countries
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