Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals

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 did increase significantly from 2010 to 2011, the
overall growth in cosmetic procedures is being primarily driven by a substantial rise in
minimally-invasive procedures. Cosmetic minimally-invasive procedures 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, such as that to be provided through application of the
Erchonia® Obesity Laser in this clinical study protocol, offers a simple, non-invasive,
safe, effective and side-effect free alternative to achieving body circumference reduction.

Justification for this assertion of anticipated safety and effectiveness of the application
of the Erchonia® Obesity Laser for the reduction of body circumference is found through
three FDA clearances for Erchonia® Low Level Laser devices for body circumference reduction
indications, as follows:

K123237 (532 nm green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a
non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to
undergo liposuction procedures for the reduction of circumference of hips, waist, and
thighs.

K121695 & K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) & Erchonia® Zerona:
is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for
individuals intending to undergo liposuction procedures for the reduction of circumference
of hips, waist, and thighs.

K121690 & K120257 (635 nm red light diodes): Erchonia® MLS, Zerona, Zerona-AD: is indicated
for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals
intending to undergo liposuction procedures for the reduction of circumference of the upper
arms.

Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for
application for body circumference reduction indications for multiple body areas, such that
evaluation of application of the Erchonia Obesity Laser to reducing body circumference in
more overweight individuals is a natural extension of its proven and accepted application
for body circumference reduction purposes.

Inclusion Criteria:

- Body Mass Index (BMI) is between 30 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 procedure (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:

- Body Mass Index (BMI) is less than 30 kg/m² or greater than 40 kg/m².

- 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, wound or other external trauma to the areas to be treated with the
laser.

- Known photosensitivity disorder.

- Current active cancer or currently receiving treatment for cancer.

- 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