puresense redensity 1 contains sterile puresense range. · 2020. 9. 3. · 1. mendoza g, et al....
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TEOSYAL® PURESENSE REDENSITY 1 contains sterile hyaluronic acid and lidocaine. This medical device (CE 0086, class III) is indicated for the prevention of wrinkles, rehydratation of the face, neck and neckline.Contraindications: it is the practionner’s full responsability to read and follow those instructions for use in order to avoid any adverse reactions or complaints. Refer to instructions for use. TEOSYAL REDENSITY ® 1 is a trademark of the firm TEOXANE SA and it is a product of the TEOSYAL®PURESENSE range.
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A MIX OF HIGHLY CONCENTRATED HYALURONIC ACID AND ESSENTIAL NUTRIENTS
* Essential amino acids cannot be made by the body. As a result, isoleucine, leucine, lysine, threonine and valine must come from food or other supplements.HA: Hyaluronic Acid AA: Amino acids1. Mendoza G, et al. Antioxidant profile of hyaluronan: physico-chemical features and its role in pathologies. Mini Rev Med Chem. 2009 Nov 1;9(13):1479-88.2. Anderegg U, et al. More than just a filler - the role of hyaluronan for skin homeostasis. Exp Dermatol. 2014 May;23(5):295-303.3. De Bandt JP, Cynober L. Therapeutic use of branched-chain amino acids in burn, trauma, and sepsis. J Nutr. 2006;136(1 Suppl):308S-13S.4. Gerard-Monnier D, Chaudiere J, Metabolism and antioxidant function of glutathion, Path. Biol.1996. 44, 77-85.5. Baspeyras M, et al. Clinical and biometrological efficacy of a hyaluronic acid-based mesotherapy product: a randomised controlled study. Arch Dermatol Res. 2013 Oct;305(8):673-82.
HYDRATION1 HA
ARGININE
TISSUE RESTRUCTURING AND CELL REGENERATION2,3
HA LEUCINE*
ISOLEUCINE*VALINE*GLYCINELYSINE*
THREONINE*PROLINE
VITAMIN B6 ZINC
COPPER
ANTIOXIDANT PROTECTION 1,4HA
GLUTATHIONE N-ACETYL-L-CYSTEIN
ALPHA-LIPOIC ACID
WITH LIDOCAINE
SKIN REDENSIFICATION
AND PREVENTION OF
THE SIGNS OF AGEING
REDENSITY1BEAUTY BOOSTER
REDENSITY 1 EXCLUSIVE PATENTED FORMULAFOR COMPLEMENTARY EFFECTS ON
SKIN CELL REGENERATION AND HEALTH 2,3
A STEP UP IN BEAUTY BOOSTING*There are potential side effects related to the implantation of this device, occurring immediately following injection or after a delay. The practitioner must inform the patient of this. Please consult the IFU for details.
Natural, highly concentrated non crosslinked HA (15 mg/ml) to improve hydration, firmness and
viscoelastic properties of the skin5
Unique patented formula of effective natural components:
8 AA (5 essentials among them leucine,essential for the cell regeneration process3)
3 antioxidants (including glutathione), recognized for their ability to protect against free radicals4
2 minerals, required for the cells’ health and protection
Vitamin B6, involved in cell metabolism
0.3% lidocaine to contribute to thepatient comfort during the injection
«Redensity1 is one of my favoriteproducts in my daily practice.
Hyaluronic acid found in Redensity1 makes the skin hydrated and
densified, and its association with nutrients makes the skin radiant and healthy.Redensity1unique properties make it safe*
to use even in thin and fragile skin.And my patients just love it so much!»
Dr. Aji Bayu Chandra, Indonesia
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MICROINJECTIONSIN SUPERFICIAL TO MID DERMIS
Evaluation of TEOSYAL® PureSense Redensity 1 efficacy on skin regeneration and protection: study carried out by an independent laboratory, measuring the effect of a bolus of product injected into the upper reticular dermis of a skin explant. This skin model displays the beneficial effects of TEOSYAL® PureSenseRedensity 1 on skinbiomarkers6
A B
OO
STER
OF
D
ERM
O-R
ESTR
UC
TUR
ING
SKIN CELL REGENERATION & OXIDATIVE STRESS PROTECTION6,7
Der
mis
TENSOR EFFECT
+ 26% of fibrillin 1Control - Day 9 Redensity 1 - Day 9
Epid
erm
al-d
erm
alju
nctio
n
STRENGTHENING OF THE DERMOEPIDERMAL JUNCTION
+ 98% collagen IVControl - Day 9 Redensity 1 - Day 9
Ep
ider
mis
HYDRATION
X 14 of GAGsControl - Day 9 Redensity 1 - Day 9
GAGs: Glycosaminoglycans6. TEOSYAL® PureSense Redensity 1 study 10E2047 on human skin explants, conducted by BIO-ECfor TEOXANE, 2010.7. TEOSYAL® PureSense Redensity 1 complementary analysis to study 10E2047.
-28% of malondialdehyde(photo-induced oxidation marker)
ANTIOXIDANT ACTION
Pap
illar
y d
erm
is
STRONG PAPILLARY DERMIS DENSIFICATION
«The cosmetic world has been revolutionizedwith Redensity1, this hyaluronic acid
potentiated with bioregenerators rejuvenatesand replenishes the skin´s nutrients
lost with age.»Dr. Alejandro Rada Cassab, Colombia
Control - Day 9 Redensity 1 - Day 9
REDENSITY 1
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FO
R A
VIS
IBLE
B
OO
ST O
F TH
E S
KIN
PROVEN EFFICACY DEMONSTRATED IN A RANDOMIZED, DOUBLE-BLINDED TRIAL VERSUS PLACEBO
«This clinical study showed a significant effect of TEOSYAL® PureSense Redensity 1 injections on skin texture, roughness and volume of lines on the cheeks, in comparison with physiological saline solution injections.»
Skin hydration was also maintained at 8 weeks in the deep dermis on the side treated and significantly reduced on the placebo side.
RESULTS VALIDATED IN AN INTERNATIONAL TRIAL
8. Study report TEOSYAL® PureSense Redensity 1 versus placebo. Pr Humbert. Dec 2014.9. Study report TEOSYAL® PureSense Redensity 1. Dr Knoll, Dr Vivier, Dr Carre, Dr Micheels. May 2013.*There are potential side effects related to the implementation of this device, occurring immediately following injection or after a delay. The practitioner must inform the patient of this. Please consult the IFU for details.
«I always obtain very positive results with an innovative product which enables
to redensify the skin and to restore itsbrightness: Redensity1.»Prof. Giuseppe Sito, ItalyELASTICITY HYDRATION TEXTURE RADIANCE
0
5
15
10
20
25
30
35
40
45
50
NECKFACE NECKLINE
SCIENTIFICALLY PROVEN, VISIBLE & LASTING RESULTS
Design: First interventional, monocenter, randomised, double-blinded, comparative study (Redensity 1 injection versus phy-siological saline solution injection)Population: n=25 patientsPrimary endpoint: evaluation of the effect of Redensity 1 injections on skin relief (roughness), in the cheek area.Protocol: 3 injections at 3-week intervals on half-face and half-neck of Redensity 1 versus physiological saline solution (NaCl). Evaluations performed at T0 (before the first injections), T8 weeks and T18 weeks timepoints.
Pr P. Humbert, France, Dec 2014 8
Design: Multicenter clinical study (3 centers)Population: n= 40 patients, 72 indications (face: n=21/ neck: n=20 /neckline: n=31)Primary endpoints: evaluation of:- protocol efficacy regardless of
the injection technique (manual multi-bolus or spray gun).
- product efficacy for the face, neck and neckline areas.
- effects sustainability along the different evaluation visits.
- safety / adverse events, immediately after injections and 3 weeks after the last injection.
Protocol: 3 injections at 3-week intervals. Evaluations performed 9 weeks after the start of the protocol.
Dr J. Carré, Dr J. Vivier, France; Dr B. Knoll, Germany; Dr P. Micheels, Switzerland,May 20139
SUPERIOR IMPROVEMENT OF SKIN ROUGHNESS (PRIMARY ENDPOINT)WITH REDENSITY 18
IMPROVEMENT OF SKIN QUALITY9
Evolution of skin relief analysed by fringe projection versus baseline
Weeks T030
35
45
40
50
55
60
T8 T18
Redensity 1Physiological saline solution
3 INJECTIONS3 WEEKS APART
µm
p=0.0011*
p=0.0409*
The treatment was very well tolerated for these three indications.*
% IM
PRO
VEM
ENT
In terms of aesthetic perception: face, neck and neckline showed an aesthetic improvement between 53% and 61%
skin quality was improved by 35%
Evaluation performed 9 weeks after the 1st injection
* Statistical analysis compared results obtained at T8 and T18 vs baseline
REDENSITY 1
-
Skin Glow and Hydration
Timeweek 0 week 3 week 6 month 6
Intensive skin nourishment and hydration Maintenance of skin health, glow and density
1 session every 4 to 6 months3 sessions at 3-week intervals
SKIN
QU
ALI
TY U
PGRA
DE
ON
TH
E LO
NG
RU
N
SEVERAL WAYS TO USE REDENSITY 1For the face, neck and neckline
• Regularly as core treatment to prevent cutaneous ageing
• In alternation with or as a complement to other treatments
• On specific chosen occasions to rehydrate and give a new glow to the skin (for example, before/after prolonged sun exposure...)
NEW PATIENTSA minimally invasive option to help them to take the first step
PATIENTS USED TO FILLER INJECTIONSIn alternation to other treatments, to maintain their results and/or as a complement to magnify the effect of a filler injection
• For an optimum treatment: 3 sessions at 3-week intervals for immediate and cumulative results
• For a maintenance treatment of the results, as soon as the need is felt: 1 session usually 3 times a year
• 2 packaging sizes available - 2 x 1 ml syringe for targeted treatments - 1 x 3 ml syringe for global aesthetic treatments
IMMEDIATE & LONG-LASTING RESULTSFOR ALL YOUR PATIENTS
«Redensity1: a natural, preventive, moisturizing and replenishing care, as well
as an excellent maintenance treatmentof hyaluronic acid injections.»Dr. Sandrine Sebban, France
A COMPLETE PROTOCOL FOR LONG-LASTING RESULTS
RADIANCE
TONICITYELASTICITYHYDRATION
REDENSITY 1
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84,7% THINK THE PROTOCOL
IS SUITABLE9
FO
R A
DE
EP
B
OO
ST O
F C
ON
FID
EN
CE
9. Study report TEOSYAL® PureSense Redensity 1. Dr Knoll, Dr Vivier, Dr Carre, Dr Micheels. May 2013.
A HIGH PATIENT SATISFACTION
91,7% ARE READY TO REPEAT
THE TREATMENT9
90,3%WOULD
RECOMMENDTHE TREATMENT9
OF PATIENTS WERESATISFIED WITH
THEIR TREATMENT9
91,7%
«This product can be used for all types and stages of ageing and provides excellent
clinical results.»Dr. Vladlena Averina, Ukraine
BRIGHTEN
PROTECTSMOOTH
REPLENISH
«As soon as Redensity1 appeared in Russia it became my favourite in the complex of anti-age treatment. Redensity1 biorevitalisation is the base that allows you to prepare the skin for more invasive manipulations and plastic surgery. The unique composition of R1
produces excellent aesthetic results without any risk of side effects and allergic reactions. It is tested by time and practice.»
Dr. Yuliya Brovkina, Russia
BEFORE
AFTER
Unstructured network (uni-directional)
Remodelled, tightened network (multi-directional)
VISIBLE AND MEASURED EFFICACY9
REDENSITY 1
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In today’s world, beauty is no longer
a question of age. Women want their
beauty to last into the future.
That’s why TEOXANE Laborator ies
s p e c i a l i s e i n t h e c o m p l e x
deve lopment o f hya lu ron ic ac id
in jecta b le ge l s w i th researcher s
dr iven by the culture of excellence
and innovat ion as wel l as a total
dedication to effectiveness and safety.
Thanks to this approach, the hyaluronic
acid gels we produce in our Geneva-
based laboratories are of the highest
quality and purity.
Mrs Valérie Taupin
CEO & Founder, TEOXANE
5003
08/0
4 -
De
ce
mb
er 2
017
TEOXANE Geneva Les Charmilles - Rue de Lyon, 105
CH 1203 Geneva www.teoxane.com