Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference

The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for
cosmetic procedures has shown significant growth over the past two years, with 13.8 million
cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since
2010. While surgical cosmetic procedures significantly increased from 2010 to 2011, the
overall growth in cosmetic procedures is primarily driven by a substantial rise in
minimally-invasive procedures that increased 6%, with nearly 12.2 million cosmetic
minimally-invasive procedures having been performed in 2011. This highlights the growing
consumer demand for non- or minimally-invasive cosmetic procedures that do not involve
surgical procedures such as liposuction and the associated risks, potential complications
and lengthy and painful recovery processes.

Low level laser light therapy (LLLT) offers a simple, non-invasive, safe, effective and
side-effect free alternative to achieving body circumference reduction. Erchonia low level
lasers, including the Erchonia® Verju™ Laser, have been determined safe and effective by the
FDA for application for body circumference reduction indications for multiple body areas.

The Iskra Medical Green PRESS 8 is a manual lymph drainage system that is also a simple,
non-invasive, safe and side-effect free alternative to achieving body circumference
reduction that has demonstrated optimal effectiveness when used in combination with other
established alternative non-invasive means of body circumference reduction such as LLLT
application.

LLLT, as applied with the Erchonia® Verju™ Laser, effects a transitory pore in the adipocyte
cell membrane that enables the fat to pass from the intracellular space into the
extra-cellular space. The Green PRESS 8 operates according to the principle of manual lymph
drainage, employing pumping of air under controlled pressure into inflatable cuffs according
to pre-set pressure, compression pause duration and therapy time parameters. The alternating
release and compression of the different vascular and lymphatic structures effects and
enhances lymphatic drainage that results in an influx of blood along with nourishing
elements, and the elimination of fluids and metabolic waste products. When used in
combination with LLLT, this process enhances and accelerates the process of reduction in the
size of adipocyte cells through increased liquefaction and emulsification of the fat through
the transitory pore in the adipocyte cell, which has been initiated by the preceding
application of LLLT.

The purpose of this study is to evaluate if green diode LLLT as applied with the Erchonia®
Verju™ Laser is more effective on reducing the circumference of the hips, waist and upper
abdomen when used in combination with the Green PRESS 8 manual lymph drainage system twice
weekly for six weeks than when used alone.

Inclusion Criteria:

- Body Mass Index (BMI) between 25 kg/m² and 40 kg/m², inclusive.

- Subject indicated for liposuction or use of liposuction techniques for the removal of
localized deposits of adipose tissues that do not respond to diet and exercise;
specifically for the indication of body contouring in the areas of the hips, waist
and upper abdomen. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines
for Liposuction Surgery developed by A joint Ad Hoc Committee of the American Society
of Lipo‐Suction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS))

- Subject is willing and able to abstain from partaking in any treatment other than the
study procedures (existing or new) to promote body contouring/circumference
reduction/weight loss during the course of study participation.

- Subject is willing and able to maintain his or her regular (typical pre-study) diet
and exercise regimen without effecting significant change in either direction during
study participation.

Exclusion Criteria:

- Known cardiovascular disease such as cardiac arrhythmias, congestive heart failure.

- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.

- Prior surgical intervention for body sculpting/weight loss, such as liposuction,
abdominoplasty, stomach stapling, lap band surgery, etc.

- Medical, physical, or other contraindications for body sculpting/weight loss.

- Current use of medication(s) known to affect weight levels/cause bloating or swelling
and for which abstinence during the course of study participation is not safe or
medically prudent.

- Any medical condition known to affect weight levels and/or to cause bloating or
swelling.

- Diagnosis of, and/or taking medication for, irritable bowel syndrome.

- Active infection, open wound (e.g. sores, cuts, ulcers, burns, etc.) or other
external trauma to the areas to be treated with the laser/lymphatic drainage system
devices.

- Known photosensitivity disorder.

- Current active cancer or currently receiving treatment for cancer.

- History of blood clots or phlebitis, other bleeding disorder

- Pregnant, possibly pregnant or planning pregnancy prior to the end of study
participation.

- Serious mental health illness such as dementia or schizophrenia; psychiatric
hospitalization in past two years.

- Developmental disability or cognitive impairment that in the opinion of the
investigator would preclude adequate comprehension of the informed consent form
and/or ability to record the necessary study measurements.

- Involvement in litigation and/or a worker's compensation claim and/or receiving
disability benefits related to weight-related and/or body shape issues.

- Participation in a clinical study or other type of research in the past 30 days.