Analytical Report TITAN. laser & light technology. Cutera, Inc. By David M. Cauger, Contributing Editor. sept. oct

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1 laser & light technology Analytical Report This is the last of my on-site product reviews for I hope these reviews have been both informative and helpful. The devices I have covered were the very latest offerings from most of the top tier companies in the business. This reality reflects the predominantly positive reporting. Aesthetic Trends & Technologies is dedicated to unbiased reporting. With this in mind, ATnT will be restructuring the product listing section in order to provide our readers with greater insight into key differences in light based products. Some of these changes will include maximum fluences at all spot sizes as well as the treatment speeds with each of these spot sizes. The goal is to reduce the confusion regarding power output and to provide you with more detailed information in order to make an informed decision. Currently, I have no financial interest nor do I receive any compensation from the companies reviewed in this series of articles or Aesthetic Trends & Technologies. These reviews do not necessarily reflect the opinion of Aesthetic Trends & Technologies. ATnTand David M. Cauger are in no way responsible for the outcome of any individual or entity, whether positive or negative, if they choose to purchase one of the products reviewed in these reports. The objective of this series is to report on products currently offered in the aesthetic medical community and to provide an avenue of understanding for those who have an interest in these devices for their practice. Cutera, Inc. (Nasdaq: CUTR) has developed a completely new product in the aesthetic device industry. The Titan was developed as a light-based answer to radio frequency skintightening devices. I fully understand that other companies (i.e. Lumenis, Syneron, Thermage, etc.) have produced, or are producing RF devices. In upcoming issues I will be covering these devices and the basic principles of bioelectrical impedance in human skin tissue that govern their clinical uses. This article will examine the Titan s thermal effects on skin tissue and the potential clinical uses which arise from this new technology. I visited Cutera s headquarters just outside San Francisco, CA, on August 9th and 10th for an in-depth inspection TITAN Cutera, Inc. By David M. Cauger, Contributing Editor of the Titan. I spent two full days with the staff of Cutera, with 80% of that time spent in the lab with the engineers and scientists. The Titan is built on Cutera s diverse Xeo platform. Its patent pending light source operates between 1100nm and 1800nm targeting water. Please do not mistake this for an IPL handpiece. All known IPL s have little power beyond 1100nm. Non-surgical skin rejuvenation procedures are the fastest growing treatments in the aesthetic industry with almost 250,000 procedures performed in Public interest is growing at an explosive rate, and patient expectations continue to rise. It is important to understand that unlike the RF devices, the Titan on the Xeo 23

2 platform may be configured and upgraded to treat hair, vascular, pigmented lesions, and traditional non-ablative collagen remodeling. COMPARISON OF TITAN TO RADIO FREQUENCY DEVICES Collagen contraction begins to occur at approximately 55 C. This can be observed immediately and is well absorption coefficient (cm^-1) Water Absorption Coefficient known to those who use the CO 2 ablative laser. This is caused by the spread of heat from the thermal zone of vaporization to the deeper reticular dermis. CO 2 procedures have been declining due to significant downtime, unwanted side effects, and complications which can frequently occur. Radio Frequency (RF) devices made their formal debut at the American Society of Laser Medicine in Atlanta in There has since been much mainstream media exposure of these devices, in particular the ThermaCool device. This RF device operates at approximately 6 megahertz delivering between 90 J/cm2 and 140 J/cm2. A ground pad is placed on the back, and the physician alters the fluences based on the treated area. Some of the issues regarding RF which have been reported to me are extreme pain levels and post-operative complications. It is important to note Titan interface wavelength (nm) that RF works on the principles of of water. The Titan uses a unique electrical resistance. The subcutaneous spectral profile between 1100nm and fat layer offers greater resistance 1800nm. This unusual light source outputs from 30 J/cm2 to 65 J/cm2, based (impedance) than skin tissue, which can create a disproportional heating of on the area being treated, resulting in the subcutaneous fat. This may lead to heating at depths from 1-3mm. The significant complications, such as fat epidermal temperature is kept at a atrophy. safe level of below 40 C by precise Furthermore, temperatures >70ºC pre-, during, and post-cooling of the for sufficient time periods will denature epidermis by a clear sapphire tip. collagen and other proteins in skin The chart above indicates that the tissue. This can lead to complications. I Titan s wavelength range is moderately personally know of two individuals absorbed by water. Wavelengths who had an RF procedure done on the shorter than 1100nm are weakly face. Both reported extreme pain levels absorbed by water and are associated during treatment. Both are now at with weak dermal heating. At approximately 1400nm 1500nm strong water least eight months post-op, and one individual has undesirable depressions absorption is associated with significant in the facial area. These outcomes may heating of the upper papillary dermis. arise from inherent design problems, Presently, the exact energy distribution across this nm spectra incorrect fluences, incomplete training, or a combination of some or all of the is a closely guarded secret and is aforementioned. It is my understanding based on both analytical and empirical that there have been modifications to data. This tailored spectrum forms the RF design, as well as a change in core of a patent submitted by Cutera. I clinical guidelines. would suspect that a majority of the By contrast, the Titan s infrared Titan s energy is around nm. spectra is both predictable and easily I also suspect that this spectrum, along understood based on the known with its pre- and post-cooling times, coefficients to the target chromophore can be altered to create the dual (Continued on page 26) 24

3 (Continued from page 24) FACIAL SKIN LAXITY Use lower fluences over bony areas such as the forehead. These areas have been found to be especially sensitive in many patients, and treatment of this area is often avoided. Treat over soft tissue of cheeks and submental area. Do not treat over the mandible (or reduce fluence if you do). effect of tightening skin laxity as well as new collagen formation in the upper papillary dermis. In any event, it is important to understand that the primary function of this device is the tightening of skin laxity in parts of the body such as the submental area, jowls, abdomen, arms, and other areas. The device may not be indicated for those areas which have structural laxity such as the nasolabial fold. While this is a difficult area to treat, some physicians are treating this area. Pain levels are reported to be well tolerated. Typical medications include Acetaminophen, Tylenol and Ibuprofen. In addition, other medications can be used to relieve anxiety and to increase patient comfort. Below is a thermal profile of an RF device versus the IR Titan. The thermal photographs below were taken on the same porcine tissue at the above fluences. Both devices were set near their upper limits. ThermaCool was on setting #17 (maxi- Titan 50 J/cm 2, 3.1 second dose ThermaCool 166 J/cm 3, 3 second dose mum setting is #19). Please note the fluence measurement is cubic centimeters. The Titan was set at 50 J/cm 2 where their maximum setting is 65 J/cm 2. The tests were performed by Cutera. In any case this illustrates that the Titan is capable of placing significant heat >60 C in the reticular dermis with perhaps a more preferable geometry and predictable depths than the RF device. In this comparative conclusion, I would choose the Titan over an RF device for the following reasons: 1) Greater safety profile, more predictable. 2) Equal or near equal in dermal heating capability. 3) Superior epidermal cooling method. 4) Scalable platform - physicians may add a variety of handpieces including Cutera s famous high power Nd:YAG laser for hair removal, leg veins, and traditional non-ablative procedures. The platform has two IPL handpieces for pigmented lesions, facial telangectasias, and rejuvenation. All of Cutera s handpieces have closed loop regulated control over power output and temperature. This ensures that the fluences you dial up are the fluences you actually output. CLINICAL USE: FACIAL SKIN LAXITY Physicians are currently using two distinct treatment approaches. One method is to use the highest tolerable fluence. The second method is to use lower fluences with a higher number of pulses in concentrated areas. This approach has shown results in lifting of the eyebrows in addition to the lower face results. What has been reported thus far is that patients who respond best are those with submental laxity and jowls. This tightening along the jaw is accomplished by treating the soft tissue of the cheeks and the submental area as shown above. COMMON TREATMENT GUIDELINES 2 to 4 passes of adjacent pulses. Fluences of 36 to 46 J/cm 2 are used over soft tissue areas such as cheeks and submental area. Titan handpiece (Continued on page 28) 26

4 (Continued from page 26) Fluences are based on patient tolerance. (Patient should be able to tolerate the treatment with no more than a moderate level of discomfort.) Fluence should be reduced approximately 10 to 15% over bone and thin skin, such as on the forehead. 2 to 3 treatments are commonly performed at monthly intervals. These parameters are based on physician feedback and provided as a guide only. Observe clinical response, patient discomfort, and area being treated to determine appropriate settings for each patient. CLINICAL USE: FACIAL LAXITY For the patient to the right, the submental and cheek areas were treated at a fluence of J/cm 2. The follow-up was taken three months after the second treatment. An immediate response was shown. There is an old saying that a picture tells a thousand words, but in this industry a bad picture can also tell a thousand lies. When I saw these before and after photos at Cutera s headquarters, I was skeptical. The response by Cutera was astounding. In collaboration with Dr. Don Groot and Dr. Bruce Russell, they spent over one year developing techniques which would reveal authentic and accurate aesthetic photographs. There are many variables which can affect the authenticity of aesthetic photographs. The description of the laborious method provided to me by David Gollnick, Vice President of Research and Development, would take a full page to explain. Pre-Treatment of Cheeks and Submental Area (top), and three months after second treatment (below) Photos courtesy of Bruce Russell, M.D. I am convinced that Cutera and the two physicians developed this method with real sincerity. I was so impressed with the detail of this method, I hope to promote a great deal of it as an industry standard. CLINICAL USE: ABDOMINAL LAXITY It is apparent that there are many clinical uses for the Titan. One which comes to mind is its possible uses in improving the surgical outcomes following specific liposuction procedures. Furthermore, its possible uses in both pre- and post- operative facial plastic surgery have only begun to be explored. COMMON TREATMENT GUIDELINES 3 to 4 passes of adjacent pulses on, and around, lax skin. Fluences of 42 to 46 J/cm 2 are commonly used with a range of 38 to 50 J/cm 2 (based on patient tolerance. Patient should be able to tolerate the treatment with no more than a moderate level of discomfort.) 2 to 3 treatments are commonly performed at monthly intervals. The number of pulses required can vary significantly from patient to patient, based on the size of the area to be treated. ABDOMEN PARAMETERS 1ST TREATMENT Use of a moderate fluence of 44 J/cm2. Pre-Treatment of Abdomen (top), and 2 1/2 weeks after second treatment (below) Photos courtesy of Don Groot, M.D. 28

5 Patient was provided with Tylenol #3, Toredol, and Ativan for comfort. A large area was covered using 400 pulses in 4 passes. ABDOMEN PARAMETERS 2ND TREATMENT The patient responded well to the first treatment so the fluence was raised to 50 J/cm2. Note: this fluence is at the high end of the range of fluences found to be tolerable by most patients. Fluence increased to 50 J/cm2. Patient was provided with Tylenol #3 and Ativan for comfort. A large area was covered using 400 pulses in 4 passes. HOW DOES THE TITAN WORK? Woman with Postpartum Skin Redundancy, before (left) and one week after (right) first treatment There are two main mechanisms. The first is immediate contraction of collagen fibrils due to thermal exposure >50 C1. The response to the temperature is related to the exposure time, and will also vary according to the patient and the location being treated. It has been postulated that a secondary contraction occurs perpendicular to the relaxed skin tension lines2. The second mechanism is a wound Photos courtesy of Bruce Russell, M.D. healing response due to selective thermal injury. Wound healing involves three phases: Inflammation, proliferation, and tissue remodeling. The discussion of the wound healing response is beyond the scope of this article and to a large degree is not fully understood. However, it is known that in the first phase, platelets release a number of chemotactic factors which attract other platelets, leukocytes, and fibroblasts. Specifically this phase continues as neutrophils and macrophages scavenge and signal other cells to begin the second phase of proliferation. In this phase the keratinocyte undergoes changes which release several proteins and enzymes which ultimately lead to the formation of granular tissue. There are vast arrays of mechanisms with many cell types in supportive roles. Finally, the third stage involves fibroblast production of new collagen, elastin, and the other components of the extra cellular matrix3. This is a very simplified overview of a very complex process. What is important to understand is what benefits this may have to patient outcomes in the lower dermis. It is my firm belief that superficial wounding of the papillary dermis in patients who have a healthy wound healing response and mild nondynamic rhytides respond best to traditional non-ablative procedures. This is the reason I would recommend the Titan in conjunction with other appropriate treatment modalities. However, the Titan addresses what other non-ablative lasers cannot. Therefore, combining other modalities will certainly lead to more satisfied patients. (Continued on page 34) Cutera Titan Specifications Wavelength nm Fluence 5 65 J/cm 2 Spot Size 10 x 15 mm Energy Control Closed Loop Photometric Treatment Cycle 4 11 seconds Xeo Console Specifications Electrical 115V/20A or 230V/20A Size 12 x 19 x 35 Weight 110 lbs. 29

6 (Continued from page 29) CUTERA PRODUCTS Above you will find a list of Cutera s products. Please note that the path of upgrade does not depend on what you first buy. A Cutera customer can upgrade in any direction. PRICE AND UPGRADES CUTERA S PRODUCT LINE The Titan by itself is available on the Xeo SA at $95,000. A good idea is to purchase the Titan with the LP 560 (list price $115,000). This allows a great synergy between a superior nm IPL unit and the Titan. This allows "three-dimensional rejuvenation" Photofacial, superficial collagen remodeling, and deep skin tightening. CONCLUDING REMARKS Cutera is without question one of the finest engineering firms in the laser aesthetic business. During my visit I was allowed unprecedented access to technical information. From infrared photography on the Titan, to digital oscilloscope testing of the pulse forming of their laser products, it was evident that Cutera had nothing to hide. One secret which separates Cutera products from the others is their great power supply and the control they have over the output of that power. I would challenge any manufacturer in the industry to best Cutera in this regard. I would like to see Cutera go even further with their platform to include a 12mm spot size on their Nd:YAG laser and integrate a variable pulsed 755nm wavelength. If Cutera were to do this, there would be no reason (other than price) to consider another company. Cutera has the engineering talent, customer service, and management to dominate the laser aesthetic industry in the future. Time will tell. For the time being, I look forward to the interesting feedback which is certain to arise from the Titan. David M. Cauger is President of Boston Aesthetics, LLC, specializing in the development and implementation of strategies for increased cosmetic practice success. Contact Mr. Cauger at: , or for light based device questions free of charge send an to: cauger1@gis.net. REFERENCES 1. Fitzpatrick, R.E., Tope, W.D., Goldman, M.P., et al. Pulsed carbon dioxide laser: a comparative clinical and histological study of cutaneous resurfacing in a porcine model. Arch Dermatol. 1996: 132: Keller, G., Rawnsley, J., Cutcliff, B., Watson, J. Erbium:YAG and carbon diox ide laser resurfacing Facial Plast Surg Clinics North rch Dermatol RE, Tope, W.D., Goldman, M.P., et al. Pulsed carbon dioxide laser: a comparative clinical and histological study of cutaneous resurfacing in a porcine model. Arch Dermatol. 1996: 132: Falabella, A.F., Falanga, V. The Biology of Skin, pp , 2001 Parthenon Publishing Group Inc