Final Results of VelaShape Study

Presented by Yoni Iger

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

EpidermisStratum corneum

Basel laminaDermis

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 perfusionResulting 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 technologiesfor performing two opposite activitiesin 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

Infraredfilter

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

2.5%

12.5%

22.5%

42.5%

12.5%

2.5%5%

7.5%7.5%

30%

35%

17.5%

2.5%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

-2 (-1)-(-2) 0-(-1) 0 0-1 1-2 2-3 3-4 4-5 5+

Circumference reduction categories

% o

f su

bje

cts

(n=4

0)

Treated Control

significant differences between control and treated sides

Before Post 10 VelaSmooth tx

Before

Post 8 VelaSmooth tx

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 increased 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 VContour and VSmooth 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

Age 21-3010%51-60

20%

41-5050%

31-4020%

VelaShape –Trial – Treated areas

• 40 anatomical areas; abdomen most requested:

• All patients treated on abdomen were pregnant before (on average 11 years earlier)

abdomen50%

buttocks30%

thighs20%

tx 2Less0%

More15%

Same85%

tx 4Less10%

More20%

Same70%

FULess15%

More10%

Same75%

VelaShape – Final Results – Patient Diaries

Diet Drinking Exercise

tx 2

Less10%

Same90%

More0%

tx 4Less

5%

Same70%

More25%

FU Less5%

Same85%

More10%

tx 2 Less15%

Same85%

More0%

tx 4 Less0%

Same100%

More0%

FU Less0%

Same85%

More15%

VelaShape – Final Results - Distribution

Circumferential Reduction 1-5

5%

28% 28%

18%

10%13%

0%

5%

10%

15%

20%

25%

30%

0 up to 2cm up to 4cm up to 6cm up to 8cm >10cm

% o

f ar

eas

(n=3

8)

Circumferential Reduction 1-FU

0%

21% 21%

24%

18%

16%

0%

5%

10%

15%

20%

25%

0 up to 2cm up to 4cm up to 6cm up to 8cm >10cm

% o

f ar

eas

(n=3

8)

Circumferential Reduction 1- 3

18%

40%

20%

13%

5% 5%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

0 up to 2cm up to 4cm up to 6cm up to 8cm >10cm

% o

f are

as (

n=38)•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 3rd treatment, pre 1 and pre 5th, 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:

Tx # versus cm improvement buttocks thigh abdomen

2 2.58 1.28 3.58

4 5.17 2.19 5.43

FU 5.93 2.50 7.37

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%

physician improvement tx 5

15%18%

48%

18%

3% 0%0%

10%

20%

30%

40%

50%

60%

1-10% 11-20% 21-30% 31-40% 41-50% 51-60%

physician improvement FU

3%

11%

18%

39%

26%

3%

0%

10%

20%

30%

40%

50%

60%

1-10% 11-20% 21-30% 31-40% 41-50% 51-60%

physician improvement tx 3

28%

55%

18%

0% 0% 0%0%

10%

20%

30%

40%

50%

60%

1-10% 11-20% 21-30% 31-40% 41-50% 51-60%

Comfort tx1

3%

30%

55%

10%

3%

0%

10%

20%

30%

40%

50%

60%

veryuncomfortable

somew hatuncomfortable

somew hatcomfortable

comfortable very comfortable

Comfort tx3

0.00%

17.50%

72.50%

10.00%

0.00%0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

veryuncomfortable

somew hatuncomfortable

somew hatcomfortable

comfortable verycomfortable

Comfort tx5

2.50% 5.00%

70.00%

20.00%

2.50%

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

veryuncomfortable

somew hatuncomfortable

somew hatcomfortable

comfortable very comfortable

VelaShape – Final Results - Comfort

More than 80% of the patients found the treatmentto be somewhat to very comfortable; the rest felt some slight discomfort

VelaShape – Final Results – Patient Ratings

improvement tx 5

5%

28%

38%

20%

10%

0%

5%

10%

15%

20%

25%

30%

35%

40%

none slight moderate good excellent

improvement tx FU

5%

29%32%

26%

8%

0%

5%

10%

15%

20%

25%

30%

35%

none slight moderate good excellent

satisfaction tx 5

3%

10%

40%

30%

18%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

not satisf ied slightlysatisf ied

satisf ied very satisf ied extremelysatisf ied

satisfaction tx FU

3%

21%

50%

13% 13%

0%

10%

20%

30%

40%

50%

60%

not satisf ied slightlysatisf ied

satisf ied very satisf ied extremelysatisf ied

improvement tx 3

13%

40%

25%20%

3%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

none slight moderate good excellent

satisfaction tx 3

3%

23%

48%

28%

0%0%5%

10%15%20%25%30%35%40%45%50%

not satisf ied slightlysatisf ied

satisf ied very satisf ied extremelysatisf ied

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

Before Post 2 VelaShape tx

Photos courtesy of Marc Winter, MD

Before Post 2 VelaShape tx

Photos Courtesy of Marc Winter, MD

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