Erchonia Medical is the manufacturer of the Zerona™, a low-level... to remove fat and contour the body without invasive surgery. ...
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.”
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