Erchonia Medical is the manufacturer of the Zerona™, a low-level laser designed
to remove fat and contour the body without invasive surgery. The conclusion of
Erchonia’s pilot study was recently presented to the American Society of Lasers
in Medicine and Surgery. The study’s data revealed that in two weeks of trials
with the LipoLaser™ – without surgery, diet restrictions or any other adjuncts –
patients lost an average of 3 inches from their waists, hips and thighs.
In contrast to high-power, high-heat lasers that are used in various surgical
procedures, the LipoLaser™ produces a low-level, or cold, output that has no
thermal effect on the body's tissue. Instead, the non-invasive laser helps the
body absorb fat by stimulating biological function. Excess fat is then removed
naturally by the body without the negative side effects and downtime associated
with more invasive procedures such as liposuction.
Renowned plastic surgeon Rodrigo Neira, M.D. who participated in the pilot study
explains, “Extensive research shows that fat congregates in interstitial spaces for
a certain amount of time.” The Zerona™ stimulates the body to rid itself of that
excess fat using the body’s normal processes. We were amazed with the results
after using the laser on patients over a period of just two weeks.”
In addition to the completed pilot study, a double blind, randomized, multi-site
and placebo controlled study is currently underway. Already the results are
consistent with the previous pilot study; in two weeks of treatment, patients are
losing as much as nine inches, and an average of over five and a half inches,
compared to the placebo group that’s losing on average a half inch.
Erchonia lasers have achieved FDA market clearance (510K) for liposuction in
2004, acne in 2005, chronic pain in 2001, and for breast augmentation in April
2008.
About the protocol in the clinical trial: Placebo patients were treated with a
635nm L.E.D. The test group was treated with the Erchonia LipoLaser™. All
patients were treated six times over two weeks. Patients were instructed not to
restrict their diets. Patients did not feel pain during the non-invasive treatment,
did not receive anesthesia, and assumed normal activities after each treatment.
Erchonia EML biochemical effects on adipose tissue.
Healthy adipose cells
Fat droplets seeping across
Adipose cell membrane
Complete collapse of adipose
cell-emulsification
The stunning series of photographs above impressively demonstrates low-level-lasers
ability to emulsify adipose tissue. The pictures reveal the collapse of the rigid adipose
cell and the secretion of triglycerides and fatty acids. These remarkable imagines
immediately reveal why laser-assisted liposuction can serve as a great benefit for the
physician and the patient.
As you begin the aspiration phase of your procedure, imagine soft emulsified adipose
tissue allowing you to apply significantly less force needed to break down the adipose
tissue; resulting in less bruising, quicker recovery times, and significant reduction of
inflammation and pain.
Why do triglycerides and fatty acids seep across the membrane?
The images directly above reveal the formation of a transitory pore forming in the bi-lipid
membrane of an adipose cell. This pore formation is the direct result of laser stimulation,
and the reason why the triglycerides and fatty acids move into extracellular space. The
pore is not damaging to the cell, but simply serves as a means for the fatty contents of the
cell to evacuate. The formation of the transitory pore is the product of a series of
secondary reactions originating in the mitochondria.
How does low-level-laser-treatment affect cells?
I will begin to walk you through a series of primary and secondary reactions that
originate in the mitochondria of a single cell and can migrate throughout the whole body!
The mitochondrion is an energy station for all eukaryotic cells, and that energy
produced in the mitochondrion is what provides life to the entire organism. The
mitochondrion is where adenosine tri-phosphate (ATP) is produced, an essential
molecule driving many reactions.
The mitochondrion is the specific target for Erchonia’s low-level-laser devices.
Specifically, cytochrome c oxidase, a terminal enzyme, is targeted by the low-levellaser. Cytochrome c oxidase is a photoacceptor, absorbing light at a peak spectrum of
630-670nm (red spectrum). This particular molecule is responsible for ensuring that the
Respiratory Chain goes to completion. The Respiratory Chain harvests electrons from
O2 and NADH passing them along through a series of Redox reactions, ultimately
producing ATP and H2O. Cytochrome c oxidase promotes the electron flow along the
Respiratory Chain between Complexes III and IV.
Low-level-laser is proposed, based on a study performed in 2005, to stimulate
photoexcitation of certain reaction centers in the cytochrome c oxidase molecule (like
CuA and CuB) influencing the redox state of these molecules, and consequently, the rate
of the electron flow in the molecule; meaning, photoexcitation of cytochrome c oxidase
may lead to redox changes and modulations of biochemical reactions through a cascade
of reactions called photosignal transduction (stimulation of other reactions).
Cytochrome c oxidase
The Biochemical Chain of Reactions!
Light stimulation at 632nm for mitochondrion (cytochrome c oxidase) photoexcitation.
Photexcitation induces change in photoaccetor (cytochrome c oxidase).
ATP levels are significantly elevated altering cellular metabolism.
Redox homeostasis occurs.
Redox transcription factors are activated and cellular signaling homeostatic cascades
from the cytoplasm via the plasma membrane to the nucleus.
Genes are activated- perhaps stimulating the formation of the transitory pore allowing for
the evacuation of the triglycerides and fatty acids.
Not every person that walks through the door is a candidate for the
Zerona™ procedure. During our clinical trials we had 71% of participants
that were very satisfied with the outcome. This leaves the other 29%.
Below lists the criteria and suggestions to enhance the results from the
Zerona™ treatment.
For the non-surgical clinical trials to be considered eligible for participation
in this study, a subject had to satisfy each of the following criteria.
 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 waist, hips and bilateral thighs. (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))
 Willing and able to abstain from partaking in any treatment other than the
study procedure (existing or new) to promote body contouring and/or weight
loss during the course of study participation. Such treatments include, but are
not limited to:
 Over-the-counter and/or prescription medications indicated to promote
body sculpting/weight loss, including dietary/herbal supplements/minerals
and appetite suppressants such as Xenical (orlistat), Meridia
(sibutramine), Alli, etc.
 Weight loss programs/diet plans such Weight Watchers, LA Weight Loss,
SlimFast, Atkin’s, etc.
 Surgical procedures to promote body sculpting/weight loss, such as
liposuction, abdominoplasty, stomach stapling, lap bands, etc.
 Alternative therapies such as acupuncture, body wraps, hypnotherapy,
etc.
 Willing and able to maintain his or her regular (typical pre-study procedure)
diet and exercise regimen without effecting significant change in either
direction during study participation.
 18 years to 65 years of age, inclusive.
 Male or female.
A subject was ineligible for participation in this study if he or she satisfied any
one or more of the following criteria.
 Body Mass Index (BMI) of 30 kg/m² or greater (body weight in ‘obese’
category according to the current standard definitions of the Center for
Disease Control (CDC) and World Health Organization (WHO) for individuals
over 18 years of age.
 Diabetes dependent on insulin or oral hypoglycemic medications.
 Known cardiovascular disease such as cardiac arrhythmias, congestive heart
failure.
 Cardiac surgeries such as cardiac bypass, heart transplant surgery,
pacemakers.
 Excessive alcohol consumption (more than 21 alcoholic drinks per week).
 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 and/or to 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.
 Pregnant, breast feeding, 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 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 90 days.
BMI
The following information is provided by the National Institute of Health.
BMI Categories:
•
•
•
•
Underweight = <18.5
Normal weight = 18.5-24.9
Overweight = 25-29.9
Obesity = BMI of 30 or greater
BMI
19
20
21
22
23
24
25
Height
(inches)
26
27
28
29
30
31
32
33
34
35
Body Weight (pounds)
58
91
96
100
105
110
115
119
124
129
134
138
143
148
153
158
162
167
59
94
99
104
109
114
119
124
128
133
138
143
148
153
158
163
168
173
60
97
102
107
112
118
123
128
133
138
143
148
153
158
163
168
174
179
61
100
106
111
116
122
127
132
137
143
148
153
158
164
169
174
180
185
62
104
109
115
120
126
131
136
142
147
153
158
164
169
175
180
186
191
63
107
113
118
124
130
135
141
146
152
158
163
169
175
180
186
191
197
64
110
116
122
128
134
140
145
151
157
163
169
174
180
186
192
197
204
65
114
120
126
132
138
144
150
156
162
168
174
180
186
192
198
204
210
66
118
124
130
136
142
148
155
161
167
173
179
186
192
198
204
210
216
67
121
127
134
140
146
153
159
166
172
178
185
191
198
204
211
217
223
68
125
131
138
144
151
158
164
171
177
184
190
197
203
210
216
223
230
69
128
135
142
149
155
162
169
176
182
189
196
203
209
216
223
230
236
70
132
139
146
153
160
167
174
181
188
195
202
209
216
222
229
236
243
71
136
143
150
157
165
172
179
186
193
200
208
215
222
229
236
243
250
72
140
147
154
162
169
177
184
191
199
206
213
221
228
235
242
250
258
73
144
151
159
166
174
182
189
197
204
212
219
227
235
242
250
257
265
74
148
155
163
171
179
186
194
202
210
218
225
233
241
249
256
264
272
75
152
160
168
176
184
192
200
208
216
224
232
240
248
256
264
272
279
76
BMI
156
36
164
37
172
38
180
39
189
40
197
41
205
42
Height
(inches)
213
43
221
44
230
45
238
46
246
254
263
271
279
287
47
48
49
50
51
52
53
54
Body Weight (pounds)
58
172
177
181
186
191
196
201
205
210
215
220
224
229
234
239
244
248
253
258
59
178
183
188
193
198
203
208
212
217
222
227
232
237
242
247
252
257
262
267
60
184
189
194
199
204
209
215
220
225
230
235
240
245
250
255
261
266
271
276
61
190
195
201
206
211
217
222
227
232
238
243
248
254
259
264
269
275
280
285
62
196
202
207
213
218
224
229
235
240
246
251
256
262
267
273
278
284
289
295
63
203
208
214
220
225
231
237
242
248
254
259
265
270
278
282
287
293
299
304
64
209
215
221
227
232
238
244
250
256
262
267
273
279
285
291
296
302
308
314
65
216
222
228
234
240
246
252
258
264
270
276
282
288
294
300
306
312
318
324
66
223
229
235
241
247
253
260
266
272
278
284
291
297
303
309
315
322
328
334
67
230
236
242
249
255
261
268
274
280
287
293
299
306
312
319
325
331
338
344
68
236
243
249
256
262
269
276
282
289
295
302
308
315
322
328
335
341
348
354
69
243
250
257
263
270
277
284
291
297
304
311
318
324
331
338
345
351
358
365
70
250
257
264
271
278
285
292
299
306
313
320
327
334
341
348
355
362
369
376
71
257
265
272
279
286
293
301
308
315
322
329
338
343
351
358
365
372
379
386
72
265
272
279
287
294
302
309
316
324
331
338
346
353
361
368
375
383
390
397
73
272
280
288
295
302
310
318
325
333
340
348
355
363
371
378
386
393
401
408
74
280
287
295
303
311
319
326
334
342
350
358
365
373
381
389
396
404
412
420
75
287
295
303
311
319
327
335
343
351
359
367
375
383
391
399
407
415
423
431
76
295
304
312
320
328
336
344
353
361
369
377
385
394
402
410
418
426
435
443
Visceral Fat
The Zerona™ device was developed following an exhaustive investigation
analyzing low-level-laser therapy’s efficacy of emulsification of fat tissue. It has
been soundly concluded that laser therapy, at a specific wavelength and
frequency proven by Erchonia Medical, induces the formation of a transitory pore
in the bilipid membrane of adipocyte cells, permitting the fatty contents housed
within these cells to trickle into interstitial space.
Low-level-laser therapy is a non-invasive technology that overwhelmingly
appeals to those individuals vigorously searching for a safe and highly effective
fat reducing procedure. However, it is important to understand the limits of this
new and innovative technology. An individual who is classified as being obese
possesses an excess amount of body fat. Fat droplets, generally composed of
triglycerides, are stored in adipocytes, and as an individual accumulates more
and more fats, the adipocytes enlarge. Adipocytes are the predominate cell of
adipose tissue. In humans, there are two regions in which adipose tissue is
located, subcutaneously and viscerally. Subcutaneous fat resides directly
beneath the skin while visceral fat is found in the peritoneal cavity around internal
organs.
Herein lies an important distinction; it is the subcutaneous fat not the visceral fat,
that the Zerona™ targets. Visceral fat is situated inside the peritoneal cavity
providing a protective cushion for our internal organs (figure 1).
Figure 1
However, as an individual accumulates fats, the adipocyte cells comprising the
visceral fat become enlarged resulting in an undesirable midsection. This
particular fat lies directly under the abdominal skeletal muscle and therefore
making it extremely difficult to treat with laser light.
As the Zerona laser penetrates the skin, the light is immediately absorbed by a
photoacceptor molecule situated in the mitochondria; it is this primary reaction
that consequentially induces a chain of secondary reactions that eventually lead
to the formation of the transitory pore. The superficial nature of the
subcutaneous fat layer allows it to be ideally targeted by the Zerona™.
Skin
Subcutaneous fat
Skeletal muscle
Visceral fat
The Zerona™ offers patients with a safe alternative to invasive
procedures by shrinking adipocytes and reducing fat. However, it is extremely
vital that the patients willing to participate in this beneficial procedure are actually
viable candidates. The appearance of enlarged fat cells within the visceral layer
may take on the same characteristics as enlarged subcutaneous adipocytes;
resulting in a protruding midsection due to the lack of stable abdominal skeletal
muscles. Erchonia wants to ensure that all clinicians adopting this technology to
better serve their patient base understand the limitations of low-level-laser
therapy; clinical studies were developed to ensure that proper statistical analysis
of this device was conducted. As our respected medical physicians carried out
the multi-site, placebo-controlled, double blind, randomized study, they quickly
observed that those participants suffering from plump visceral layers were unable
to achieve the results those with enlarged subcutaneous layers were able to
obtain.
The Zerona™ provides a head start for those individuals wishing to
change their life, but it is most important that the patient fully understands the
limitations of laser therapy; therefore, without a lifestyle change to help manage
visceral fat, the patient may not see the results he or she strongly desires or the
Zerona™ promises. Erchonia strives for perfection, and we want to ensure that
our products are reliable and supported by clinical data, and through our
scientific exploration we have uncovered the full benefit and limitations of our
device and wish to share this knowledge with you, the highly regarded clinician.
Safety Considerations
The Zerona™ procedure uses a class lllb laser device. By the FDA criteria, this
means with chronic eye exposure one might encounter eye injury, so protective
eyewear is provided for patients. Unlike the ablative light and laser sources used
in many cosmetic practices, this risk is extremely low and would require long
term exposure.
Extensive clinical work has never demonstrated an adverse skin reaction to the
Erchonia low-level laser therapy. In fact, resolution of skin irritations has
occurred with Erchonia low-level laser. While many medications can be
photosensitizing agents, this has not been a problem with low-level laser.
While no detrimental affects have been shown with low-level lasers and
pregnancy, it is not suggested to use this device on a pregnant patient.
Having a pacemaker is not a contraindication to low-level laser, but it is
suggested that a treatment not be performed directly over the pacemaker or the
pacing-wires pathway.
An open wound is never a contraindication to low-level laser and is actually an
indication at the appropriate settings to assist with healing.
When one uses an ablative laser like erbium or CO2, very small setting changes
can make a significant difference in clinical results. Also, the number of passes
one takes over the site is very important in tissue ablation. This is not the case in
low-level laser therapy.
Practitioners have followed these protocols and expanded upon it to best treat
the patient and in some cases enhanced the overall results. Some examples of
this are adding Niacin B-6, and Compression Garments to the Zerona™ protocol.
Niacin with Zerona™
Niacin is a water-soluble vitamin whose derivatives such as NADH play
essential roles in energy metabolism in the living cell and DNA repair. During
metabolic reactions such as fatty acid oxidation and glycolysis, NAD+ serves as
an oxidizing agent, oxidizing certain compounds can lead to the breakdown fats
and carbohydrates, which ultimately can lead to the production of ATP (energy).
In recent years, Erchonia Medical Laser, a producer of low-level-lasers,
has developed a dual-diode laser that emits two 635nm collimated line-generated
beams to emulsify fat. In a preliminary study performed by Dr. Neira, it was
found using electron microscopy that a transitory pore in the adipocyte cell
membrane appeared to form following 6 minutes of irradiation with Erchonia’s
dual-diode electric laser at 10Mw. The formation of the transitory pose allowed
for fat to pass from the intracellular space into the extra-cellular space. Dr.
Neira’s research was reaffirmed by Dr. Susan Lim using a Standard and Cryo
Scanning Electron Micrographs, in which she demonstrated the formation of the
transitory pore as well as the movement of fat droplets across the membrane.
The biochemical effect of Erchonia’s dual-diode laser is believed to
stimulate the mitochondria of the adipocyte cells. Following the stimulation of the
mitochondria, there is an increase in the production of ATP. The newly
synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate
(cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the
conversion of triglycerides into fatty acids and glycerol that can easily pass
through the cell membrane. The transitory pore is evidence that the laser is
allowing for the movement of fatty acids, glycerol, and triglycerides to pass
across the membrane and into extra-cellular space.
With the application of oral Niacin, it is believed that oxidation of the fatty
acids and triglycerides can occur within the extra-cellular space. NAD+, a
derivative of Niacin, is an extremely reactive molecule. Niacin is a good oxidizing
agent; meaning, it is readily available to take a hydrogen molecule from another
compound. One of the crucial steps in the breakdown of fatty acids and
glycolysis is the use of NAD+ to oxidize fatty acids and sugar molecules to
produce ATP.
In addition to Niacin’s ability to oxidize molecules, Niacin is also a
vasodilator. Vasodilation is the dilation and expansion of blood vessels (veins,
arteries). With the relaxation and dilation of nearby blood vessels, it is possible
for the fatty acids and triglycerides sitting in the extra-cellular space to be
absorbed into the blood stream rather than reabsorbed by the adipocyte cell. We
believe that oral Niacin taken after the Erchonia laser treatments will cause the
vasodilation of nearby blood vessels and arteries, ( results presented at ASLMS
2008) allowing for the absorption of the newly released fatty acids and
triglycerides.
In addition, oral Niacin is commonly prescribed to lower blood cholesterol levels
as well as lower triglyceride levels. It has been shown that Niacin can lower
plasma triglyceride levels by 20 to 50 percent. Two hypotheses for the
mechanism of Niacin to lower triglyceride levels is believed to be that Niacin
directly inhibits hepatic synthesis or secretion of apolipoprotein B containing
lipoproteins or niacin has the potential to cause a generalized inhibition of
synthetic function in the liver. The latter of the two hypotheses supports the idea
that fatty acids can not be synthesized into triglycerides; therefore, the fatty acids
released due to the stimulation with the Erchonia Laser will be oxidized rather
than formed into triglycerides.
Therefore, the use of both topical Niacin and oral Niacin during and after
treatment with a dual-diode laser can accelerate the breakdown of the fatty acids
and triglycerides to produce ATP. (Patent Pending) Erchonia’s dual-diode laser
will cause the fatty acids and triglycerides to leak across the adipocyte cell
membrane into extra-cellular space. The application of topical niacin at the site
of laser treatment will lead to the vasodilation of nearby blood vessels.
Furthermore, oral Niacin, which is a strong oxidizing agent, will begin oxidizing
triglycerides and fatty acids within the extra-cellular space. Finally, with the
consumption of an oral version of Niacin, it is believed that the ingested Niacin
will work to oxidize the fatty acids and triglycerides that were delivered from the
blood to specific tissues, as well as prevent the synthesis of new triglycerides
within the liver.
This technique and the devices used are patent/patent pending.
Compression Garments
The garments are being worn after the first treatment for 14 days. You do not
treat through the garment, just have them remove it then put back on after
treatment.
Zerona Procedure Protocol
Each Patient receives six total procedures with the Zerona™ across the
consecutive two-week procedure administration phase; three procedures per
week; each one at least two days but no more than three days apart.
• Example- Monday, Wednesday, and Friday or Tuesday, Thursday, and
Saturday. *** NOTE: Deviating from this schedule will impact the
potential effectiveness due to the time factor of the adipose cell
remaining emulsified. ***
“The procedure administration protocol for each session is as follows:
a) Procedure administration protocol for the front of the patient’s body:
1. The patient enters the procedure room and lies comfortably flat on his or
her back on the table such that the front area of the subject’s body
encompassing the region spanning from the subjects’ stomach (abdomen)
down though the hips and frontal aspect of both thighs, is facing upwards.
2. The center diode of the Zerona™ is positioned at a distance of 6.00 inches
above the patient’s abdomen (stomach), centered along the body’s
midline (the “line” that vertically “dissects” the body into two equal halves)
and focused on the navel. By the design of the device, this placement of
the center diode results in the other four diodes being positioned 120
degrees apart and tilted 30 degrees off the centerline of the center
scanner.
3. The Zerona™ is activated for 20 minutes. The laser emits to the patient a
laser beam of approximately 15 mW with a wavelength of 635 nm, and
creates a spiraling circle pattern that is totally random and independent
from the others. These patterns overlap each other to guarantee total
coverage within the target area (the patient’s abdomen, hips and thighs).
The target area is approximately 8.00 x 10.00 inches or 80 square inches
(approximately 516 square centimeters).
b) Procedure administration protocol for the back of the patient’s body:
1. The patient turns over to lie flat on his or her stomach such that the back
area of the subject’s body encompassing the region spanning from the
subjects’ back down though the hips and back aspect of both thighs, is
facing upwards.
2. The center diode of the Zerona™ is positioned at a distance of 6.00 inches
above the subject’s back, centered along the body’s midline (the “line” that
vertically “dissects” the body into two equal halves) and focused on the
equivalent spot to the navel’s location on the stomach, as if along a line
dissecting the body horizontally from front to back at the navel. By the
design of the device, this placement of the center diode results in the other
four diodes being positioned 120 degrees apart and tilted 30 degrees off
the centerline of the center scanner.
3. The Zerona™ is activated for 20 minutes. The laser emits to the patient a
laser beam of approximately 15 mW with a wavelength of 635 nm, and
creates a spiraling circle pattern that is totally random and independent
from the others. These patterns overlap each other to guarantee total
coverage within the target area (the patient’s back, hips and thighs). The
target area is approximately 8.00 x 10.00 inches or 80 square inches
(approximately 516 square centimeters).
The total laser energy that the patient is exposed to, front and back
treatments combined, is approximately 6.60 joules per square centimeter.”