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


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Cellulite Reduction with Syneron Laser Technology

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

  1. 1. Presented by Yoni Iger
  2. 2. What is body shaping? <ul><li>Reshaping of different anatomical zones of the body by altering structure and function of superficial connective tissues. </li></ul><ul><li>The mission The target </li></ul>Before After Epidermis Stratum corneum Basel lamina Dermis Hypodermis
  3. 3. <ul><li>Atrophic degeneration of the hypodermal and dermal zones: </li></ul><ul><ul><li>Hypertrophic and hyperplasic changes of fat cells </li></ul></ul><ul><ul><li>Mal-performance of the venous and lymphatic system </li></ul></ul><ul><ul><li>Glycation of collagen and hypertrophic septae </li></ul></ul><ul><ul><li>Disturbed blood perfusion </li></ul></ul><ul><ul><li>Resulting in </li></ul></ul><ul><ul><li>Advantage to the fat cells having relatively low metabolism </li></ul></ul><ul><ul><li>Cyclic atrophy leading to </li></ul></ul><ul><ul><li>- Increased circumferences </li></ul></ul><ul><ul><li>- Bumpy appearance </li></ul></ul>What is the etiology?
  4. 4. <ul><li>To initiate anabolic (construction) processes in the dermis, together with catabolic (destruction) processes in the hypodermis: </li></ul><ul><li>- Blood circulation ↑ </li></ul><ul><li>- Fibroblasts activity ↑ </li></ul><ul><li>- Lymphatic and venal drainage ↑ </li></ul><ul><li>- Fat cell activity ↑ </li></ul><ul><li>Using a set combination of technologies for performing two opposite activities in two different tissue depths </li></ul><ul><li>Is it do-able? </li></ul>What is the need? What is the challenge?
  5. 5. <ul><li>Infrared light heats the tissue up to 3mm depth </li></ul><ul><li>RF heats tissue from 2 to ~20mm depth </li></ul><ul><li>Vacuum +/- massage enables determination of location of target versus energy, together with other impacts </li></ul>Lamp Parabolic reflector Infrared filter RF electrodes A B Synergistic use of energies
  6. 6. What is the actual biological impact? <ul><li>Increased metabolism - Anabolic ↔ Catabolic </li></ul><ul><li>Mechanical manipulation (vacuum +/- massage): </li></ul><ul><ul><li>Stimulates lymphatic drainage and blood perfusion </li></ul></ul><ul><ul><li>Facilitates fibroblast activity </li></ul></ul><ul><ul><li>Reduces viscosity of fat cells clusters </li></ul></ul><ul><ul><li>Promotes vasodilation & extravasation oxygen & nutrients </li></ul></ul><ul><ul><li>Heating at pre-determined depths </li></ul></ul><ul><li>Heating (IR + RF) </li></ul><ul><ul><li>Enhances blood perfusion & increases oxygen dissociation from oxy-hemoglobin </li></ul></ul><ul><ul><li>Facilitates fibroblast activity </li></ul></ul><ul><ul><li>Increases metabolism of fat cells </li></ul></ul><ul><ul><li>Tightens the skin (septae and overall collagen) </li></ul></ul>
  7. 7. VelaShape History <ul><li>VelaSmooth (precursor product) received FDA clearance for cellulite reduction (2005) and thighs circumferences reduction (2007) </li></ul><ul><li>A large scale multi-center clinical study based on up to 12 treatments with VelaSmooth showed: </li></ul><ul><li>- Cellulite and skin texture improvement. </li></ul><ul><li>- An average of 1.9 cm , and up to 7.2 cm circumferences reduction. </li></ul><ul><li>Circumferences reduction was also proved in a randomized controlled trial (hence, currently specific FDA clearance for thighs). </li></ul>
  8. 8. FDA Controlled Trial Summary significant differences between control and treated sides
  9. 9. Before Post 10 VelaSmooth tx
  10. 10. Before Post 8 VelaSmooth tx
  11. 11. VelaShape Development <ul><li>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. </li></ul><ul><li>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% </li></ul><ul><li>Technical improvements, including option of dual connector for V Contour and V Smooth applicators. </li></ul>
  12. 12. VelaShape Research <ul><li>IRB-approved clinical studies were submitted to FDA and CE with safety data of 92 tx. sessions. </li></ul><ul><li>The company is actively engaged in more than 15 investigational sites worldwide: </li></ul><ul><li>- Efficacy - Treatment protocols - New indications (e.g., sagging skin following pregnancy or liposuction) </li></ul>
  13. 13. VelaShape Study - Demographics <ul><li>1 clinical site, US </li></ul><ul><li>20 patients, all females </li></ul><ul><li>Regular exclusion criteria, including no obesity </li></ul><ul><li>Average age 43.7 ± 1.7 years (27-56 years) </li></ul><ul><li>5 tx, weekly interval, FU </li></ul><ul><li>Enhanced treatment mode </li></ul>
  14. 14. VelaShape –Trial – Treated areas <ul><li>40 anatomical areas; abdomen most requested: </li></ul><ul><li>All patients treated on abdomen were pregnant before (on average 11 years earlier) </li></ul>
  15. 15. VelaShape – Final Results – Patient Diaries Diet Drinking Exercise
  16. 16. VelaShape – Final Results - Distribution <ul><li>Average distribution of treated areas </li></ul><ul><li>Non responders declined with tx to 0 </li></ul><ul><li>Shift of responders score to the right </li></ul><ul><ul><li>Tx 3 (post 2) 58%<2, 33%=2-6, 10% >6cm </li></ul></ul><ul><ul><li>Tx 5 (post 4) 33%<2, 46%=2-6, 23%>6cm </li></ul></ul><ul><ul><li>FU (4Wks) 21%<2, 45%=2-6, 34>6 cm </li></ul></ul><ul><li>Delta between pre 1 and pre 3 rd treatment, pre 1 and pre 5 th , pre 1 and FU </li></ul>
  17. 17. VelaShape – Final Results - Average <ul><li>Following 2 weekly treatments , the average circumferences reduction was 2.82 ± 0.55 cm . </li></ul><ul><li>In percentage reduction vs. baseline: 2.86 ± 0.52%. </li></ul><ul><li>Following 4 weekly treatments , the average circumferences reduction was 4.7 ± 0.77 cm . </li></ul><ul><li>In percentage reduction vs. baseline: 4.77 ± 0.77%. </li></ul><ul><li>At follow up , the average circumferences reduction was 5.93 ± 0.79 cm . </li></ul><ul><li>In percentage reduction vs. baseline: 6.07 ± 0.69%. </li></ul>
  18. 18. VelaShape – Final Results - Areas <ul><li>Patients’ weight did not change significantly (167.9 vs. 167.7 lb). </li></ul><ul><li>Circumferences significantly reduced </li></ul><ul><ul><li>Looking at the anatomical area categories: </li></ul></ul>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
  19. 19. VelaShape –Final Results – Skin texture <ul><li>Skin texture improvement as per the physicians’ evaluation: </li></ul><ul><li>Tx 3 < 30%, peak 11-20% </li></ul><ul><li>Tx 5 < 50%, peak 21-30% </li></ul><ul><li>FU < 60%, peak 31-40% </li></ul><ul><li>At least 30% </li></ul><ul><ul><li>Tx 3 0% </li></ul></ul><ul><ul><li>Tx 5 21% </li></ul></ul><ul><ul><li>FU 68% </li></ul></ul>
  20. 20. 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
  21. 21. VelaShape – Final Results – Patient Ratings
  22. 22. VelaShape –Final Results <ul><li>Correlation between patients’ assessment of improvement and their satisfaction: </li></ul><ul><li>Tx 3 - 76% Tx 5 - 65% FU - 83% </li></ul><ul><li>Response to treatment was limited to erythema and edema that lasted several hours. </li></ul>
  23. 23. Before Post 2 VelaShape tx Photos courtesy of Marc Winter, MD
  24. 24. Before Post 2 VelaShape tx Photos Courtesy of Marc Winter, MD
  25. 25. Before Post 2 VelaShape tx Photos courtesy of Marc Winter, MD
  26. 26. Before Post 2 VelaShape tx Photos Courtesy of Marc Winter, MD
  27. 27. Before Post 2 VelaShape tx Photos Courtesy of Marc Winter, MD
  28. 28. Before Post 2 VelaShape tx Photos Courtesy of Marc Winter, MD
  29. 29. Summary <ul><ul><li>VelaShape is intended for circumferences reduction and cellulite appearance improvement due to its concomitant ability to: </li></ul></ul><ul><ul><ul><li>Reduce the fat cells and chambers dimensions </li></ul></ul></ul><ul><ul><ul><li>Tighten the skin </li></ul></ul></ul>