1. The Science of the Zerona
2. Zerona Basics
• The Zerona device employs 5 independent laser
• The wavelength utilized falls within the visible
spectrum at 635nm
• The intensity is 17.5 mW per diode, categorizing
the laser as a class IIIb.
• The device emits a patented line-generated
beam, which allows the Zerona to deliver a high
concentration of photons across a large surface
3. Low-level laser therapy
• Low-level laser therapy (LLLT) continues to gain
more and more acceptance as a viable
application for myriad neurologic, dental,
ophthalmic, dermatologic disorders, and injuries.
• LLLT operates under the scientific principle of
photochemistry, and does not employ a
photoacoustic or photothermal mechanism.
• For the physician and the patient, the beneficial
clinical outcome is produced without any adverse
• Common logic is that laser’s must provoke a thermal event in order
to produce the clinical outcome.
– Not the case with LLLT
• Photochemistry is the modulation of biochemical reactions via the
absorption of photons.
• Similar to a drug-cell interaction, laser therapy targets photo-
accepting receptors, which upon stimulation, induces an intra-
cellular biological cascade.
• The wealth of studies have revealed LLLT’s ability to:
– to preserve membrane and genetic material of cells that are
– regenerate erythrocytes enhancing their oxyphoric function
– stimulate the differentiation of satellite stem cells
– reduce extent of myocardial infarctions and ischemic strokes
– accelerate wound healing
– modulate chronic inflammation .
• The primary target of laser therapy is the photo-
acceptor molecule housed within the mitochondria.
• The stimulation of this receptor upregulates the
production of Adenosine Triphosphate (ATP) and
Reactive Oxygen Species (ROS).
• ATP serves as a catalyst for a wide-assortment of
• ROS modulates the intra-cellular redox state which
regulates transcription factor activation and gene
• Laser therapy is a non-invasive approach to provoke a
biological response many major pharmaceutical
companies attempt alter.
6. The Scientific Foundation of Zerona
Dr. Rodrigo Neira utilizing scanning electron
microscopy (SEM) and transmission electron
microscopy (TEM) evaluated the morphological
alterations of adipocytes subsequent to LLLT.
Moreover, Dr. Neira used MRI to assess the depth
penetration capabilities of low-level laser.
Dr. Susan Lim employed basic adipocyte staining
techniques and SEM and TEM imagery in order to
duplicate the work of Dr. Neira.
Dr. Arturo Ramirez analyzed optical transmission of
adipocytes following LLLT to observe morphological
changes within the fat cell.
 Dr. Neira revealed the formation of an aperture or transitory power in the
membrane of the fat storing cell (adipocytes) following laser irradiation at 635nm.
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.
8. Alteration of the Bilipid Membrane
Copyright 2008 Erchonia Medical
De e p
2 Min. -
9. Transitory Pore
The formation of the
provides a means for
the stored fatty
material to seep out of
the cell and into
10. Transformation of adipocytes
• SEM and TEM reveal the transformation from
a voluminous state to a collapsed state.
11. Transformation of adipocytes (cont’d)
• More images reveal the collapse of adipocyte
arrangements subsequent to laser irradiation.
12. Copyright 2008 Erchonia Medical
a c0 Minute 1 Minute 6 Minutes
12 Minutes 18 Minutes
CONVENTIONAL - SEM
13. Dr. Arturo Ramirez
Control (top), Series results
Two sets of
14. MRI imaging (T1 and T2 sequences)
15. Does light penetrate that far?
• The physical penetration of photons cannot
exceed 1 or 2 cm.
• The observable emulsification extending 5 cm
into the subcutaneous fat is attributed to the
systemic effect associated with LLLT.
16. • Multiple studies have identified that non-irradiated adjacent cells undergo the same
photo-induced changes based on the upregulation of intercellular communicators.
• Laser therapy has been shown to promote a paracrine effect, similar to histamine in the
sense that intercellular communicators are released (i.e. nitric oxide and chemokines),
influencing non-irradiated cells.
• A study has shown that when adipose tissue located on the right side of the body is
treated by ZERONA LLLT, the adipose tissue of the left side of the body endures fat
•Jackson, R., Roche, G., Butterwick, K.J., Dedo, D.D. and Slattery, K., Low-level
Laser-assisted liposuction: A 2004 clinical trial of its effectiveness for enhancing ease of l
iposuction procedures and facilitating the recovery process for patients undergoing thigh, hip,
and stomach contouring. AM. J. Cosmet. Surg. 2004:21(4);191-8.
•Schindl, A., Heinze, G., Schindl, M., Pernerstorfer-Schon, H. and Schindl, L. Systemic effects
of low-intensity laser irradiation on skin microcirculation in patients with diabetic
microangiopathy. Microvascular Research. 2002;64:240-46.
• Dr. Barnes will discuss a slimming effect in areas that are not directly treated by laser
therapy, this is a direct result of the paracrine effect promoted by laser therapy.
ZERONA LLLT Systemic effect
17. Proposed Mechanisms
• 1.) Lipid Peroxidation
– Because of electron excitation within the ETC a greater amount
of ATP and ROS are produced.
– ROS are highly reactive, and in some instances begin reacting
with membrane-bound cholesterol molecules.
– The breakdown of cholesterol within the membrane weakens its
structural integrity and may induce the formation of a pore.
18. Building upon the foundation
• The histological evidence warranted a placebo-conrtolled,
double-blind, randomized, multi site clinical study.
• Sixty-seven subjects were enrolled
– 35 test participants
– 32 control participants
• Patient’s waist, hip, and thighs were treated simultaneously.
• Patients were treated consecutively for two weeks, every-
other-day (MWF), for a total of 6 treatments.
• No other modalities were embrace, patients were unable to
make any positive changes to their diet and exercise habits.
19. Success Criteria
• Individual subject success criteria was defined as at
least 3.0 inch reduction in combined circumference
measurements for the waist, hip and bilateral thighs
from baseline to after completion of the two-week
study procedure administration protocol phase.
• The overall study success criterion, established by
the Food and Drug Administration (FDA), was
defined as at least a 35% difference between
treatment groups, comparing the proportion of
individual successes in each group.
20. Results: Total Reduction
Mean change in total combined circumference measurements
from baseline to endpoint for treatment groups (n=67)
Comparison of the two independent group means for the
continuous variable of mean change in total combined
circumference (total number of inches) from study baseline
to endpoint demonstrated a mean difference of -2.837 . The
difference was found to be statistically significant (t = -7.30;
df = 65; p<0.0001).
21. Results: Meeting Success Criteria
The total number and percentage of treatment group participants
meeting the individual success criteria (n=67)
This outcome exceeded the
pre-established target of 35%
difference between treatment
groups by 22%.
22. Once liberated, where does the fat go?
• The fat leaves the cell and enters into the
• The fatty material is absorbed by the lymphatic
system, transported via afferent lymph vessels
to lymph nodes, where triglycerides are broken
down via lipases (Lysosomal Acid Lipase), and
finally transported to the circulatory system
where the debris can be processed by the liver
(fatty acid oxidation).
• Overall, the body has a natural system in place
to transport and degrade triglycerides without
inducing an adverse outcome.
23. Safety Parameters
• It is absolutely imperative that any non-invasive device claiming to
remove fat or slim the body provide serum cholesterol and
• To ensure that patients were not going to experience an elevation
in triglyceride and total cholesterol levels subsequent Zerona, a 19
patient pilot trial was performed assessing pre-procedure and post
procedure lipid panels.
• No patients experienced an unsafe elevation in both total
cholesterol and triglyceride levels; in fact, 85% of patients
demonstrated a decrease in cholesterol levels in just two weeks.
• This data has inspired Erchonia to pursue a clinical trial assessing
laser therapy’s ability to serve as an alternative modality to lower
• For Zerona, these results place the device in its own category. A
slimming device that is more than just a cosmetic tool.
24. Positive effects on Body
• Eighty-four percent of study participants demonstrated an overall reduction in
cholesterol serum levels. The reduction ranged from -1.0 to -32.0 mg/dL with
an average reduction of -17.6 points. Seventy-four percent of participants
revealed a reduction in low-density-lipoprotein (LDL) levels while 58.0% of
participants either maintained or demonstrated an increase in high-density-
lipoprotein levels. Of the 19 participants, 58.0% showed a reduction in serum
triglyceride levels with an average reduction of 27.45 mg/dL.
• 22 of 22 patients participating in a separate pilot trial demonstrated a
reduction in the adipose-derived hormone Leptin.
• Further, of the 22 participants, the average change in LDL from baseline to
study end point was -16.28 points or -15.65%. Based on the FDA Guidance
Document which states a change in LDL from baseline to study end point
evaluation is considered both statistically significant and clinically meaningful if
it is a 15% or greater decrease, our results were clinically meaningful
25. Patient experiences: The certain vs. the
ZERONA emulsifies the fat 100% of the time on
100% of the patients; unfortunately, not all
patients can successfully mobilize and
degrade the fatty debris.
– There are contraindications that will prevent the body
from absorbing and processing the emulsified fat
• It is yet to be determined, but it is believed that certain
individuals based upon their lymphatic vessel structure are
unable to deliver the fat away from the interstitial space in a
• For the patient this means minimal results.
26. Patient Experiences
Contraindications for ZERONA® Treatment
Patients with the following conditions should not be treated:
– Pregnant or breast-feeding
– Liver disease
– Kidney disease
– Disease of the lymphatic system
– Cancer (active or within 1 year of remission)
– Use a pacemaker
– Currently/Regularly taking anti-inflammatory medication (ex. Corticoid steroids)
Conditions that must be monitored; yet, are treatable:
— Cardiovascular disease (i.e. hypertension)
— Suffering from metabolic disorders (i.e. hypothyroidism and diabetes)
— Use of prescription grade NSAIDS
Other Criteria to Ensure Positive Results:
Female patients should wait at least one week post menstrual cycle to begin
ZERONA treatments. ZERONA is less effective during menstruation.
Patients who have undergone liposuction will have varied results due to the presence
of potential scar tissue formation and potential damage to lymphatic vessels.
27. Modalities to assist
• It is essential that patients are properly hydrated. The lymphatic
system is an open ended system that requires a proper level of
interstitial fluid in order to flush out the fatty debris.
• Moreover, the lymphatic system requires skeletal muscle
movement; therefore, patients should embrace a lymphatic
stimulation protocol, i.e. basic exercise and compression garments.
• Curva, a supplement formulated specifically for Zerona helps
enhance the body’s natural pathways used to transport and
breakdown the fat.
– 200mg Niacin
– 200mg Green Tea Extract
– 100 mg L-carnitine
– 60 mg Ginkgo Biloba
– 880 mg of Omega 3 and Omega 6 fatty acids
28. The Zerona
• It is becoming clear that more and more patients
are seeking cosmetic procedures that are non-
invasive, safe, quick, and effective.
• The Zerona is the only clinical proven non-
invasive device that can promise the reduction of
inches in just two weeks!
• The question regarding Zerona is not what side-
effects are there; but, what more can this device
do for me besides promoting a slimming effect?