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1

2 SPHEROFILL TACTICS

3 CE MARKED: 0476 All rights and patents reserved Promoitalia Group S.p.A.

4 CE MARKED: 0476 All rights and patents reserved Promoitalia Group S.p.A. SPH ATI SPHEROFILL TACTICS INDICATIONS SPHEROFILL Tactics and Hyaluronic Acid dermal filler: A dream come true! Spherofill Tactics : is the one and only revolutionary and fashionable device that, throughout the creation of a capsule that is autologous, containing and protective at the same time, makes the safest filling product on the market such as Hyaluronic Acid to finally last in the long-time frame. Let s have the results of a semi-permanent filler with the safest one: Hyaluronic Acid. Thanks to the Spherofill Tactics it is possible to save a remarkable quantity of HA Indications: Fine, medium and deep wrinkles (periocular, nasolabial, perilabial wrinkles,, marionette line) facial depressions and contour remodeling, glabellar areas, chin, nose tip * correction of big depressed scars (zygomatic area, profile correction)

5 ERO SSP The injection technique is the 3D ELLIXE TACTICS SPHEROFILL Tactics and Mesotherapy: Spherofill Tactics is utilized in combination with mesococktails of various compositions (Nucleotides, antioxidants, hyaluronic acid, vitamins, amino acids) and it is able to revitalize the cutaneous tissue and stimulate fibroblasts to synthesize new constituents of the connective (collagen and elastic fibres) contemporaneously. Indications: fine lines stretch marks acne scars telangectasie cuperose peeling The injection technique is the MULTIPUNCTURE SPHEROFILL Tactics without any product: The P-RFR wave released by the special needlelike electrode determines a thermal microdamage able to carry out a bio-stimulation of the fibroblast activity and a consequential regeneration of the dermal matrix. Indications: small wrinkles of the periocular area small scars stretch marks The injection technique is the 3D ELLIXE TACTICS THE POWER OF INNOVATION Spherofill Tactics combines two patented technologies which make it an unique and revolutionary device: the P-RFR and the 3D ELLIXE TACTICS

6 PHE TICS WHAT HAPPENS IN THE DERMIS? P-RFR RECALL OF MACROPHAGES TGF- : IS IMPORTANT FOR THE CREATION OF REPAIRING TISSUE FROM WHICH THE CONTAINMENT CAPSULE ORIGINATES RECALL OF NEUTROPHILS FGF (FIBROBLAST GROWTH FACTORS) PDGF INSULIN-LIKE GROWTH FACTORS P-RFR WAVE: SPHEROFILL TACTICS uses a newly patented bipolar electric wave called P- RFR (two wave lenghts Radio- Frequency Radio, delivered through 2 pre-set programs), able to stimulate a targeted scarring process, granting: No thermolysis No thermic damage No pain The P-RFR wave determines, on a microarea of the tissue, a containing healing reaction featured by the recall of neutrophils able to produce FGF These growth factors in turn recall microphages that produce TGF-, important for the formation of reparative process from which the containing capsule, home of the filler, originates. Right in the moment of the operation, the P-RFR wave stimulates the creation of the capsule, that then becomes fully structured and even, in the following 48 hours.

7 3D ELLIXE TACTICS The P-RFR is transmitted through the 3D ELLIXE TACTICS. This technique, through a needle-like electrode, generates a protective capsule where the Cross- Linked Hyaluronic Acid dermal filler is also released. Insertion and penetration of the needle along the wrinkle course with a variable depth from the superficial to the middermis, depending on the type of wrinkle and on the type of filler used. Once in situ, a rotation of 360 is performed in order to create a virtual canal contextually supplying the P- RFR. This procedure is to be repeated in retrograde and multipricking tecniques along the wrinkle course. Afterwards, without ever leaving the injection site, the needle retraces the course releasing hyaluronic acid by using a linear retrograde technique. N.B: in combination with the bio-revitalizing cocktails, the MULTIPUNCTURE technique is used, which foresees, for each injection, the release before a discharge of P-RFR, able to determine the stimulation of autologous collagen and elastic fibres, and subsequently, the release of micro-quantities of biorevitalizing cocktails, able to bring preformed substances, of which the tissue results to temporarily lack. Wrinkle smoothing with a Long Lasting effect.

8 RESULTS MEDICAL REPORT: BEFORE The distance between the skin and the osseous layer is of 6.3mm IMMEDIATELY AFTER THE TREATMENT Immediately after the treatment, an increase of the hyperechogenicity (more whitish area) is assisted to, a clear sign of hyper-reactivity 48 HOURS AFTER THE TREATMENT The distance between the skin and the osseous layer is varied from 6.3 to 7.2 mm The increase of the hyperechogenicity (more whitish area) persists in an even more highlighted manner in the capsule, which in this case also results to be structured. 12 MONTHS AFTER THE TREATMENT The distance between the skin and the osseous layer is varied from 6.3 to 7.8 mm. Hyperechogenicity persists (more whitish area) and the canal-form structure is visualized inside of which we may notice the presence of the hyperecogen filler in the ecographic image. 18 MONTHS AFTER THE TREATMENT The hyperecogen areas are reduced in favour of small hyperecogen spots, a sign of partial re-absorption of the filler in favour of a wellorganized connective structure.

9 HISTOLOGY All the sections were treated with paraffin and coloured with haematoxylin and eosin. Initial inflammatory reaction with recall of Neutrophils Previous picture enlargement. Neutrophils emphasized Enlarged frame of the newly formed collagen (green arrows) and initial formation process of the autologous capsule out from the P-RFR action Featuring Prof. A.Baldi from Istituto di Anatomia Patologica della Seconda Università degli Studi di Napoli (SUN) Italia. Gathering of the newly formed connective tissue

10 BEFORE Pre-treatment picture of the under-labial wrinkle AFTER Post filler-treatment picture of the underlabial wrinkle. It shows an increase of the distance between skin and osseous layers from 0.93cm to 1.55cm. The structure of the tissue is almost unchanged. COMPARATIVE PICTURES: BEFORE Pre-treatment picture of the naso-labial wrinkle. Distance between skin and osseous layers is of 0.68 cm AFTER Post-treatment picture of 12 months. It shows an increase of hyperechogenicity, signal of a tissue hyper-reaction, and an increase of the distance between the skin and osseous layers from 0.68cm and 1.45cm

11 ACNE SCARS: BEFORE AFTER RESULTS: BEFORE AFTER 1 SESSION AFTER 18 MONTHS MESOTHERAPY: BEFORE AFTER STRETCH MARKS: BEFORE AFTER

12 PHE TICS SPHEROFILL TACTICS FEATURES: 2 easy-to-use pre-set programs, for different kinds of treatments Variable and adjustable power (not higher than 12 W) Needle-like electrodes at different sizes, for different wrinkle types, connected to the device, to the syringe and to the mini-patch, closing which closes the bipolar electric circuit. The NEEDLE LIKE electrode is available in various sizes in relation to the viscosity of the filler: - 30 G needle to use with Ha mg/ml 18 Cross-linking level G needle to use with Ha mg/ml 24 Cross-linking level G needle to use with Ha mg/ml 24 Cross-linking level +++ No down time No surgical theatre Comfortable & painless treatment No anaesthesia Portable device Rechargeable battery Battery level light Weight: 2,5Kg

13

14 SPHEROFILL IS AVAILABLE IN THREE DIFFERENT FASHIONABLE COLOURS BLACK SILVER WHITE CE MARKED: 0476 All rights and patents reserved Promoitalia Group S.p.A.

15 BIBLIOGRAPHY Goldberg DJ, Koch J, Burns J, Geronemus R. A New Non-Ablative Radio Frequency Device to Tighten Tissuo: A Randomized Trial Comparing a Single Treatment to Multiple Treatments. Alster TS, Tanzi EL. Treatment of Prominent Nasolabial Folds and Cheek Laxity with a Nonablative Radiofrequency Device. Tanzi EL, Alster TS. Improvement of Neck Laxity with a Nonablative Radiofrequency Device: A Lifting Experience. Fitzpatrick RE, Iyer S. Collagen and Tissue Tightening: Paradigm for Treatment of the Cheeks and Neck Using Radiofrequency. Fitzpatrick RE, Geronemus R, Goldberg D, Klaminer M, Kilmer S, Ruiz-Esparza, J. First Multi-Center Study of a New Non-Ablative Radio Frequency Device to Tighten Facial Tissue. Ruiz-Esparza J. "Non-Ablative Radiofrequency Tissue Tightening of Facial Skin: The Medical Face-Lift: A Report of 25 Patients". Weiss RA, Weiss MA, Beaseley KL. "Monopolar Radio Frequency (RF) Mediated Skin Contraction of the Lower Face: Study of 35 Patients". Alster TS. "Radiofrequency Treatment: A Non-Surgical Approach to Skin Tightening and Other Applications". Ruiz-Esparza J. "The Non-Surgical Face-Lift Via Non-Ablative Radiofrequency". Grossman KL. "Radiofrequency Treatments for Facial and Neck Laxity and Brow Ptosis". Jacobson L. "One-Year Assessment Following Radiofrequency Treatment to the Lower Face and Neck". Nahm W. "Radiofrequency applied to Half of Face Ipsilaterally Produces Elevation of The Brow, Changes in the Angle of the Eyebrow, and Improvement in Appearance of Melolabial Fold and Jowl". Fitzpatrick RE, Geronemus R, Goldberg D, Klaminer M, Kilmer S, Ruiz-Esparza, J. "Multicenter Study of Noninvasive Radiofrequency for Periorbital Tissue Tightening". Lasers in Surgery and Medicine Vol. 33, No. 4; Lyer S, Suthamjaryiya K, Fitzpatrick RE. "Using a Radiofrequency Energy Device to Treat the Lower Face: A Treatment Paradigm for a Nonsurgical Facelift". Cosmetic Dermatology Vol. 16, No. 2; February Ruiz-Esparza J, Gomez JB. "The Medical Face Lift: A Noninvasive, Nonsurgical Approach to Tissue Tightening in Facial Skin Using Nonablative Radiofrequency". Dermatol Surg Vol. 29, No. 4, p ; April Zelickson BD. "Histologiacal and Ultrastructural Evaluation of the Effects of a Radiofrequency-Based Nonablative Dermal Remodeling Device". Archives of Dermatology Vol. 140, p ; February Alster T.A., Tanzi E. "Improvement of Neck and Cheek Laxity With a Non-Ablative Radiofrequency Device: A Lifting Experience". Dermatol Surg Vol 30, p ; April Book Chapters Thompson DO, Chaubal MV. Cyclodextrins (CDS) excipients by definition, drug delivery systems by function (part I: injectable applications). Drug Delivery Technology. 2002;2(7):34-38.

16 EXPORT OFFICE ITALY Naples Via Antiniana, 59 Ph Fax ITALIAN BRANCH ITALY Milan Via San Gregorio, 44 Ph Fax ITALY Rome Via Della Stazione di Ciampino, 32 Ph ASIAN BRANCH THAILAND Bangkok th Floor, Bubhajit Building 20 North Sathorn Road Ph Fax PROMOITALIA FACTORY ITALY Rome Via Della Stazione di Ciampino, 32

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