Vela Shape%20 Study Winter Mar%2013%2008[1]

What is body shaping? Reshaping of different anatomical zones of the body by altering structure and function of superficial connective tissues. The mission The target Before After Epidermis Stratum corneum Basel lamina Dermis Hypodermis

Atrophic degeneration of the hypodermal and dermal zones: Hypertrophic and hyperplasic changes of fat cells Mal-performance of the venous and lymphatic system Glycation of collagen and hypertrophic septae Disturbed blood perfusion Resulting in Advantage to the fat cells having relatively low metabolism Cyclic atrophy leading to - Increased circumferences - Bumpy appearance What is the etiology?

To initiate anabolic (construction) processes in the dermis, together with catabolic (destruction) processes in the hypodermis: - Blood circulation ↑ - Fibroblasts activity ↑ - Lymphatic and venal drainage ↑ - Fat cell activity ↑ Using a set combination of technologies for performing two opposite activities in two different tissue depths Is it do-able? What is the need? What is the challenge?

Infrared light heats the tissue up to 3mm depth RF heats tissue from 2 to ~20mm depth Vacuum +/- massage enables determination of location of target versus energy, together with other impacts Lamp Parabolic reflector Infrared filter RF electrodes A B Synergistic use of energies

What is the actual biological impact? Increased metabolism - Anabolic ↔ Catabolic Mechanical manipulation (vacuum +/- massage): Stimulates lymphatic drainage and blood perfusion Facilitates fibroblast activity Reduces viscosity of fat cells clusters Promotes vasodilation & extravasation oxygen & nutrients Heating at pre-determined depths Heating (IR + RF) Enhances blood perfusion & increases oxygen dissociation from oxy-hemoglobin Facilitates fibroblast activity Increases metabolism of fat cells Tightens the skin (septae and overall collagen)

VelaShape History VelaSmooth (precursor product) received FDA clearance for cellulite reduction (2005) and thighs circumferences reduction (2007) A large scale multi-center clinical study based on up to 12 treatments with VelaSmooth showed: - Cellulite and skin texture improvement. - An average of 1.9 cm , and up to 7.2 cm circumferences reduction. Circumferences reduction was also proved in a randomized controlled trial (hence, currently specific FDA clearance for thighs).

FDA Controlled Trial Summary significant differences between control and treated sides

VelaShape Development Performance - VelaShape was developed on the scientific principles discussed, with a modified vacuum pattern and increased RF (50 Watts) , while maintaining IR levels (i.e., keeping the device’s suitability to all skin types). This lead to i ncreased efficacy, while maintaining a high safety profile. Business model considerations - VelaShape offers shorter treatment sessions and a reduced number of treatments for high-volume medical clinics: - 4-6 sessions - Each session shortened on average by 30% Technical improvements, including option of dual connector for V Contour and V Smooth applicators.

VelaShape Research IRB-approved clinical studies were submitted to FDA and CE with safety data of 92 tx. sessions. The company is actively engaged in more than 15 investigational sites worldwide: - Efficacy - Treatment protocols - New indications (e.g., sagging skin following pregnancy or liposuction)

VelaShape Study - Demographics 1 clinical site, US 20 patients, all females Regular exclusion criteria, including no obesity Average age 43.7 ± 1.7 years (27-56 years) 5 tx, weekly interval, FU Enhanced treatment mode

VelaShape –Trial – Treated areas 40 anatomical areas; abdomen most requested: All patients treated on abdomen were pregnant before (on average 11 years earlier)

VelaShape – Final Results – Patient Diaries Diet Drinking Exercise

VelaShape – Final Results - Distribution Average distribution of treated areas Non responders declined with tx to 0 Shift of responders score to the right Tx 3 (post 2) 58%<2, 33%=2-6, 10% >6cm Tx 5 (post 4) 33%<2, 46%=2-6, 23%>6cm FU (4Wks) 21%<2, 45%=2-6, 34>6 cm Delta between pre 1 and pre 3 rd treatment, pre 1 and pre 5 th , pre 1 and FU

VelaShape – Final Results - Average Following 2 weekly treatments , the average circumferences reduction was 2.82 ± 0.55 cm . In percentage reduction vs. baseline: 2.86 ± 0.52%. Following 4 weekly treatments , the average circumferences reduction was 4.7 ± 0.77 cm . In percentage reduction vs. baseline: 4.77 ± 0.77%. At follow up , the average circumferences reduction was 5.93 ± 0.79 cm . In percentage reduction vs. baseline: 6.07 ± 0.69%.

VelaShape – Final Results - Areas Patients’ weight did not change significantly (167.9 vs. 167.7 lb). Circumferences significantly reduced Looking at the anatomical area categories: 7.37 2.50 5.93 FU 5.43 2.19 5.17 4 3.58 1.28 2.58 2 abdomen thigh buttocks Tx # versus cm improvement

VelaShape –Final Results – Skin texture Skin texture improvement as per the physicians’ evaluation: Tx 3 < 30%, peak 11-20% Tx 5 < 50%, peak 21-30% FU < 60%, peak 31-40% At least 30% Tx 3 0% Tx 5 21% FU 68%

VelaShape – Final Results - Comfort More than 80% of the patients found the treatment to be somewhat to very comfortable; the rest felt some slight discomfort

VelaShape – Final Results – Patient Ratings

VelaShape –Final Results Correlation between patients’ assessment of improvement and their satisfaction: Tx 3 - 76% Tx 5 - 65% FU - 83% Response to treatment was limited to erythema and edema that lasted several hours.

Before Post 2 VelaShape tx Photos courtesy of Marc Winter, MD

Before Post 2 VelaShape tx Photos Courtesy of Marc Winter, MD

Summary VelaShape is intended for circumferences reduction and cellulite appearance improvement due to its concomitant ability to: Reduce the fat cells and chambers dimensions Tighten the skin

Vela Shape%20 Study Winter Mar%2013%2008[1]

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