BODY CONTOURING WITH A
MULTIPLE DIODE LASER SYSTEM
Steven Shanks
John Shanks
Information contained within presentation and presentation
Copyright©2008 Erchonia Medical
Why Erchonia began to study LLLT as
a safe alternative
„ LLLT (3LT) at 635nm has demonstrated a unique
ability to target Adipose Cells and stimulate
emulsification of the fat in the cell, as early as 1999.
„ Stunning images have been published with the
Erchonia laser that exemplify this amazing
biochemical effect.
„ Time, wavelength and output power were critical, and
most other philosophies were incorrect.
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Obesity-Unfortunately A Growing
Trend in the United States
1990
1995
2005
No Data
<10%
10%–14%
15%–19%
20%–24%
25%–29%
≥30%
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(*BMI ≥30, or about 30 lbs overweight for 5’4” person)
Source: Mokdad A H, et al. J Am Med Assoc 1999;282:16, 2001;286:10.
Addressing The Trend- Problems
„ The ability to target Adipose Cells in obese patients
has demonstrated to be a difficult and dangerous
task.
„ The market has provided the consumer with
invasive-surgical options such as lipoplasty; as well
as dangerous over-the-counter pills that attempt to
increase an individual’s metabolic rate.
„ Although remarkable results can be achieved with
lipoplasty, serious side-effects can occur along with
extensive and timely recoveries.
„ Non- invasive products are long on advertising and
short on actual science.
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Early work showing how the laser
works
„ Published in the Plastic and
Reconstructive Surgery journal 2001
„ Aesthetic Surgery Journal 2002
„ AACS journal 2001 and 2004
„ Clinics and Plastic Surgery 2006
Figure 1 (Above) -- SEM Picture. The adipocytes have round
shape; contours are regular having a grape-cluster shape.
Picture magnification of 190x. This figure has received tumescent
solution.
Figure 2A (Left)-- SEM picture. Application of the laser
beam for 4 minutes Only few adipocytes are liquefied, there
is preservation of some cell membrane, some has lost its
original shape 190Xmagnifications times. Arrows point out
fat particles coming from inside to outside of the adipose
cell.
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How the laser works (continued)
„
„
„
Liposuction: Principles and Practice
2006
International Science award 2002
for his work on adipocytes by
Rodrigo Neira M.D.
US patent/Patent Pending
Neira/Shanks
Figure 3 (Left) -- SEM picture. Application of the laser beam for 6
minutes shows that there are not round adipocytes; you only see
fat liquefied 190Xmagnification times. Arrows point out fat coming
out of the adipose cell
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How the Laser Works (continued)
Figure 6 – TEM picture. Shows the cell membrane at 60000X magnification. After 6 minutes of laser
exposure, the membrane is temporarily disrupted creating a transitory pore (see single arrow) that
allows the liquefied fat to come out of the cell and be released into the interstitial space. Double arrow
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Erchonia Medical
points out the fat particles released from
inside2008
the cell.
How the laser works
With Laser (1 Min)
With Laser (6 Mins)
Mins)
With Laser (12 Mins)
Mins)
„
„
Presented by Susan Limm
M.D. Singapore published
results at the AACS
meeting 1/2005.
Note: no Tumescent
solution introduced
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How the laser works
•Study conducted by
Arturo RamirezMontana M.D.
•Conducted on serial
patients
Research presented at
the Plastic Surgery
Society in Merida,
Mexico 2003.
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How Laser Works - Safety and Efficacy
Control (top), Irradiated at 0 minutes (below)
Series results (right)
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How far the laser penetrates.
MRI T1 sequence – O min
Fat appears bright and the
tumescent solution dark
MRI T1 sequence - 4 min
There is partial
coalescence of adipose
tissue
MRI T1 sequence - 6 min
There is homogeneity of fat
tissue
Rodrigo Neira M.D. Pictures published 2001 AACS
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How far the laser penetrates.
MRI T2 sequence – O min
Fat is dark and tumescent
solution is bright
MRI T2 sequence - 4 min
There is partial
coalescence of adipose
tissue
MRI T2 sequence - 6 min
There is homogeneity of fat
tissue
Rodrigo Neira M.D. Pictures published 2001 AACS
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Proving The Concept – Pilot Study
„ The purpose of our study was to determine if a safe and non-
invasive body contouring procedure could be developed based
on the biochemical evidence of LLLT’s ability to emulsify fat.
„ In order to determine the overall effectiveness of a multiple
diode low-level-laser device, 16 patients were recruited for a two
week pilot study with a BMI of 22 or Above.
„ The pilot study was approved by an IRB.
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Treatment Device
„ The device utilized was a multiple diode laser system designed and
manufactured by Erchonia Medical Laser®.
„ The device was fitted with 5 laser diodes which emitted laser at 635nm.
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Treatment Device
„ The laser in the clinical trial has the unique
ability to scan the entire waist, hips and thighs
at the same time to ensure complete
coverage of the treatment area which saves
time
„ We also wanted a device that was unmanned
for the purpose of ease and marketing.
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Developing the Protocol
„ On the basis of Neira’s, Limm’s, and
Rameriz-Montana’s we know we could
Emulsify fat with the 635 wavelength.
„ It also had been proven that a cell would
reabsorb the fat after 42 hours, establishing
why treatment must be every two days.
„ Moving to a Non-Hand Held device to
establish treatment time number of
treatments was a matter of trial and error.
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Pilot Study Results
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Results
„ Average inches by measurement point: n=16
Average inches
Pre-Treatment
End of Week 2
Waist
44.14
42.86
Hips
51.28
49.94
Right Thigh
27.46
25.75
Left Thigh
26.93
25.43
„ Change in circumference measurements from
pre-treatment to end of week 2: n=16
Pre-treatment
End of week 2
Change in inches
% change
Waist
44.14
42.86
-1.28
-2.85%
Hips
51.28
49.94
-1.34
-2.40%
Right Thigh
27.48
-1.73
-4.82%
Left Thigh
26.93
-1.50
-3.88%
25.75
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25.43
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Results (Waist)
Individual subject waist circumference: Pre-treatment to end of
week 2: n=16
Subject
Pre-treatment
End of week 2
Change in ins.
1
40
38.5
-1.5
% Change
-3.90%
2
33.5
32.5
-1
-3.08%
3
35
35.5
0.5
1.41%
4
98
93
-5
-5.38%
5
79
76
-3
-3.95%
6
46.5
45.1
-1.4
-3.10%
-3.10%
7
33.3
32.3
-1
8
37.6
35.4
-2.2
-6.21%
9
31.3
29.9
-1.4
-4.68%
10
33.5
31.9
-1.6
-5.02%
11
38
37.8
-0.2
-0.53%
12
32.7
31.1
-1.6
-5.14%
13
35.8
35.2
-0.6
-1.70%
14
34.1
31.7
-2.4
-7.57%
15
50.4
49.2
-1.2
-2.44%
16
47.6
50.6
3
5.93%
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Results (Hips)
„ Individual subject hip circumference: Pre-treatment to end of
week 2: n=16
Subject
Pre-treatment
End of week
2
Change in
ins.
% Change
1
49
47.5
-1.5
-3.16%
2
38.5
39.5
1
2.53%
3
39.5
40
0.5
1.25%
4
106
103
-3
-2.91%
5
97
93
-4
-4.30%
6
54.3
52.8
-1.5
-2.84%
7
39
36.6
-2.4
-6.56%
8
46.5
40.9
-5.6
-13.69%
9
37
36.2
-0.8
-2.21%
10
41.7
41.7
0
0.00%
11
43.3
43.5
0.2
0.46%
12
39
38.8
-0.2
-0.52%
13
42.5
41.1
-1.4
-3.41%
14
40.6
39.4
-1.2
-3.05%
53
-1.1
-2.08%
52
-0.4
-0.77%
15
54.1
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52.4
10
Results (Right Thigh)
„ Individual subject right thigh circumference: Pre-treatment to
end of week 2: n=16
Subject
Pre-treatment
End of week 2
Change in ins.
% Change
1
31
29
-2
-6.90%
2
24
22
-2
-9.09%
3
22
22.5
0.5
2.22%
4
57
53
-4
-7.55%
5
57
44.5
-12.5
-28.09%
6
26
25.8
-0.2
-0.78%
7
21.5
21.7
0.2
0.92%
8
23.2
23.6
0.4
1.69%
9
19.7
19.3
-0.4
-2.07%
10
23.6
21.3
-2.3
-10.80%
11
23.2
22.8
-0.4
-1.75%
12
19.3
18.5
-0.8
-4.32%
13
21.3
20.5
-0.8
-3.90%
14
19.7
18.5
-1.2
-6.49%
25.2
-1.6
-6.35%
23.8
-0.2
-0.84%
15
26.8
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24
Results (Left Thigh)
„ Individual subject left thigh circumference: Pre-treatment to end
of week 2: n=16
Subject
Pre-treatment
End of week 2
Change in ins.
% Change
1
29
28
-1
-3.57%
2
23
22
-1
-4.55%
3
20.25
21.5
1.25
5.81%
4
57
53
-4
-7.55%
5
56
44
-12
-27.27%
6
24.6
24.8
0.2
0.81%
7
20.1
21.3
1.2
5.63%
8
24
23.2
-0.8
-3.45%
9
19.7
19.3
-0.4
-2.07%
10
23.6
21.3
-2.3
-10.80%
11
23.2
23.2
0
0.00%
12
19.3
18.1
-1.2
-6.63%
13
21.3
20.7
-0.6
-2.90%
14
19.3
18.1
-1.2
-6.63%
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26.2
Medical
24.2
-2
-8.26%
16
24.2
-0.2
-0.83%
24.4
11
Conclusion
It was concluded that LLLT can serve as a safe,
noninvasive, and effective alternative to current
invasive body contouring procedures especially for
obese patients.
„ Each region treated displayed an overall reduction in
inches in the pilot clinical trial.
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Zerona™
(To Shrink)
Botox for over weight people
12
How does the laser work for
Zerona™?
SEM –
Deep
2 Min.-
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How does the laser work for
Zerona™?
SEM –
Deep 6
Min.-
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Tumescent 6 minute with laser
Conventional and Cryo SEM
– both clearly show collapsed
adipocytes. Very flat
topography is seen in the
cryo SEM sample.
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Susan Lim
18 minutes
Conventional SEM –
many empty cells with
broken membrane
Cryo SEM – many empty
sacs due to drainage of cell
content or shrinkage of cells
due to emptying process.
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Susan Lim
14
CONVENTIONAL - SEM
a
0 Minute
1 Minute
c
12 Minutes
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6 Minutes
18 Minutes
Susan Lim
How does
the laser
work for
Zerona™?
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Zerona™
Clinical
trial
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Zerona™
Clinical
trial
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Zerona™
Clinical
trial
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Clinical trial
„ Study completed 7/08
„ Statistical analysis and supporting
documentation submitted to the FDA for the
510(k) - Non Invasive Body Contouring -August 2008.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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Clinical
trial
results.
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When will the 510(k) happen and
ongoing questions from the FDA.
„ Data submitted August 2008
„ First reply came on October 14th 2008
„ Questions answered and sent back that afternoon.
„ FDA (Richard Felton) Committed to having statistical
review from the FDA by the end of the month (October).
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On-Going
Questions
with the
FDA
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On-Going
Questions
with the
FDA
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FDA
„ Heard back from FDA on October 24th 2008
with more questions. (2)
„ Replied to the FDA request for more
information on October 30th there main
concern. Lipid Panels.
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FDA Lipid panels
„ At the 2008 ASLMS meeting we presented the
research on Zerona™, ran into Richard Felton and
discussed new study and “how to” speed up the
510(k) process. (Breast Aug 510(k) took 9 months).
„ He mentioned we would need to determine where the
fat was going and then committed to expedite the
process and was looking forward to the information.
„ We then decided to start lipid panel study.
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FDA
„ We did 20 lipid panel studies anticipating the
FDA would require this research.
„ The following is what was submitted as
additional research based on this study.
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Lipid Panel
Studies
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Lipid Panel
Studies
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Lipid Panel
Studies
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Lipid Panel
Studies
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Lipid Panel
Studies
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Lipid Panel
Studies
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Lipid
Panel
Studies
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FDA
„ It makes sense that we would drop
triglyceride and bad cholesterol levels.
„ We believe that the body will rid itself of fat as
the system allows.
„ May be the reason why people with same
BMI get different results.
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FDA
„ The FDA has no problem with results as our emails
show.
„ We set individual success pre study along with the FDA
as minimum of 3 inches which we acceded easily.
„ They have the data on safety ( Lipid Panels) which will
make this study even more valuable.
„ We may be able to claim that we are making patients
healthier which our research shows.
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FDA
„ We believe the FDA market clearance or
510(k) is emanate.
„ Based on this being our 6th time going
through the 510k process and the questions
from the FDA.
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The study
„ Study submitted to JAMA and should publish
next year (clinical trial).
„ The lipid panel study will be published next
year in the AACS journal.
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Competitors
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Focused Ultrasound
Taken from Ultrashape website
„ “Can not treat Extensive non-localized fat”
Zerona™ pilot study showed good results
„ “Fibrotic or cellulite may not respond”
Zerona™: Cellulite and previous LIPO patients have responded well
„ “Small area’s like flanks can take 1 hour”
Zerona™: Can treat waist, hips and thighs in 40 minutes
„ “Total time for Large area’s can take 2 hours or more along with preparing
treatment area, getting the patient into the correct position, measuring the
patients and setting up the device”.
Would take 4 hours to treat area the size of Zerona™
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Focused Ultrasound
„ “Side effects can include blisters and mild erythema”
No recorded side effects with 3LT™ in 40 years of
research
„ “Study of 3 treatments at 30 day intervals or 90 days
showed: 3.95cm reduction treating abdomen, flanks,
thighs, knee’s and pseudo- gynecomastea”.
Zerona™ results in 2 weeks average of 8.75 cm.
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Focused ultrasound
„ “Procedure must be performed by an experienced trained person”.
Zerona™: Simple and easy.
„ “Patient selection is important to reduce the risk of potential adverse
effects”
Zerona™: No known side effects.
„ “New treatment time takes 1 month”.
Zerona™: Still 2 weeks and patients will see results in 1 week.
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Comments
„ Focused Ultrasound requires trained personnel to administer protocol.
Zerona™: Align heads and walk away.
„ Treatment times mean only a few people can be treated each day.
Zerona™: Can treat a new patient every 40 minutes.
„ Kills the cell
Zerona™: Creates a transitory pore and cell remains alive.
„ Creates scar tissue and must wait for body to heal before additional
treatments.
Zerona™: Can treat area as many times as Doctor see’s fit.
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Zerona™
„ Better results, faster with no known side
effects.
More treatments can be performed daily.
„ Fat cells are not destroyed.
„ For the physician, no need to hire additional
staff to perform treatment.
„ We believe FDA clearance eminent.
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Thank you.
Questions?
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