Why Erchonia began to study LLLT as a safe alternative · 3 Copyright 2008 Erchonia Medical Early work showing how the laser works Published in the Plastic and Reconstructive Surgery

1

BODY CONTOURING WITH A

MULTIPLE DIODE LASER SYSTEM

Steven ShanksJohn Shanks

Information contained within presentation and presentation Copyright©2008 Erchonia Medical

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.

2


Obesity-Unfortunately A Growing Trend in the United States

1995

(*BMI ≥30, or about 30 lbs overweight for 5’4” person)

2005

1990

No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%

Source: Mokdad A H, et al. J Am Med Assoc 1999;282:16, 2001;286:10.


Addressing The Trend- ProblemsThe 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.

3


Early work showing how the laser works

Published in the Plastic and Reconstructive Surgery journal 2001Aesthetic Surgery Journal 2002AACS journal 2001 and 2004Clinics 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.


How the laser works (continued)

Liposuction: Principles and Practice 2006International 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

4


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 points out the fat particles released from inside the cell.


How the laser works

Presented by Susan Limm M.D. Singapore published results at the AACS meeting 1/2005.Note: no Tumescent solution introduced

With Laser (1 Min)With Laser (1 Min) With Laser (6 With Laser (6 MinsMins))

With Laser (12 With Laser (12 MinsMins))

5


How the laser works

•Study conducted by Arturo Ramirez-Montana M.D.

•Conducted on serial patients

Research presented at the Plastic Surgery Society in Merida, Mexico 2003.


How Laser Works - Safety and Efficacy

Control (top), Irradiated at 0 minutes (below) Series results (right)

6


How far the laser penetrates.

Rodrigo Neira M.D. Pictures published 2001 AACS

MRI T1 sequence – O minFat 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


How far the laser penetrates.

Rodrigo Neira M.D. Pictures published 2001 AACS

MRI T2 sequence – O minFat 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

7


Proving The Concept – Pilot StudyThe 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.


Treatment DeviceThe 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.

8


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.


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.

9


Pilot Study Results


Results

Average inches by measurement point: n=16

Change in circumference measurements from pre-treatment to end of week 2: n=16

25.4326.93Left Thigh

25.7527.46Right Thigh

49.9451.28Hips

42.8644.14Waist

End of Week 2Pre-TreatmentAverage inches

-3.88%-1.5025.4326.93Left Thigh

-4.82%-1.7325.7527.48Right Thigh

-2.40%-1.3449.9451.28Hips

-2.85%-1.2842.8644.14Waist

% changeChange in inchesEnd of week 2Pre-treatment

10


Results (Waist)Individual subject waist circumference: Pre-treatment to end of

week 2: n=16

5.93%350.647.616

-2.44%-1.249.250.415

-7.57%-2.431.734.114

-1.70%-0.635.235.813

-5.14%-1.631.132.712

-0.53%-0.237.83811

-5.02%-1.631.933.510

-4.68%-1.429.931.39

-6.21%-2.235.437.68

-3.10%-132.333.37

-3.10%-1.445.146.56

-3.95%-376795

-5.38%-593984

1.41%0.535.5353

-3.08%-132.533.52

-3.90%-1.538.5401

% Change Change in ins.End of week 2Pre-treatmentSubject


Results (Hips)Individual subject hip circumference: Pre-treatment to end of week 2: n=16

-0.77%-0.45252.416

-2.08%-1.15354.115

-3.05%-1.239.440.614

-3.41%-1.441.142.513

-0.52%-0.238.83912

0.46%0.243.543.311

0.00%041.741.710

-2.21%-0.836.2379

-13.69%-5.640.946.58

-6.56%-2.436.6397

-2.84%-1.552.854.36

-4.30%-493975

-2.91%-31031064

1.25%0.54039.53

2.53%139.538.52

-3.16%-1.547.5491

% Change Change in

ins.End of week

2Pre-treatmentSubject

11


Results (Right Thigh)Individual subject right thigh circumference: Pre-treatment to end of week 2: n=16

-0.84%-0.223.82416

-6.35%-1.625.226.815

-6.49%-1.218.519.714

-3.90%-0.820.521.313

-4.32%-0.818.519.312

-1.75%-0.422.823.211

-10.80%-2.321.323.610

-2.07%-0.419.319.79

1.69%0.423.623.28

0.92%0.221.721.57

-0.78%-0.225.8266

-28.09%-12.544.5575

-7.55%-453574

2.22%0.522.5223

-9.09%-222242

-6.90%-229311

% Change Change in ins.End of week 2Pre-treatment

Subject


Results (Left Thigh)Individual subject left thigh circumference: Pre-treatment to end of week 2: n=16

-0.83%-0.224.224.416

-8.26%-224.226.215

-6.63%-1.218.119.314

-2.90%-0.620.721.313

-6.63%-1.218.119.312

0.00%023.223.211

-10.80%-2.321.323.610

-2.07%-0.419.319.79

-3.45%-0.823.2248

5.63%1.221.320.17

0.81%0.224.824.66

--27.27%27.27%--12124444565655

-7.55%-453574

5.81%1.2521.520.253

-4.55%-122232

-3.57%-128291

% Change Change in ins.End of week 2Pre-treatment

Subject

12


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.

Zerona™(To Shrink)

Botox for over weight people

13


How does the laser work for Zerona™?

SEM –Deep 2 Min.-


SEM –Deep 6 Min.-

How does the laser work for Zerona™?

14


Tumescent 6 minute with laser

Conventional and Cryo SEM – both clearly show collapsed adipocytes. Very flat topography is seen in the cryo SEM sample.

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.

Susan Lim

15


a c0 Minute 1 Minute 6 Minutes

12 Minutes 18 Minutes

CONVENTIONAL - SEM

Susan Lim


How does the laser work for

Zerona™?

16


Zerona™Clinical trial


Zerona™Clinical

trial

17


Zerona™Clinical trial


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.

18


Clinical trial results.



19





20





21





22





23





24





25


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).


On-Going Questions with the FDA

26


On-Going Questions with the FDA


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.

27


FDA Lipid panelsAt 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.


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.

28


Lipid Panel Studies


Lipid Panel Studies

29


Lipid Panel Studies


Lipid Panel Studies

30


Lipid Panel Studies


Lipid Panel Studies

31


Lipid Panel Studies


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.

32


FDAThe 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.


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.

33


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.


Competitors

34


Focused UltrasoundTaken 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™


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.

35


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.


CommentsFocused 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 cellZerona™: 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.

36


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.


Thank you.

Questions?

Documents

Why Erchonia began to study LLLT as a safe alternative · 3 Copyright 2008 Erchonia Medical Early work showing how the laser works Published in the Plastic and Reconstructive Surgery