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Ulthera - physics and technology behind
1. Ulthera, Inc. 2150 S. Country Club Drive. Suite 21 Mesa, AZ 85210
Tel 480.619.4069 fax 480.619.4071 info@ulthera.com www.ulthera.com
2. The Face Ages From The Inside Out
Treat It That Way!
Outside In
Radio Frequency
Outside In
Lasers & RF
Inside Out
MF Ultrasound
CONFIDENTIAL
3. The Face Ages From The Inside Out
Treat It That Way!
Outside In Inside Out
Radio Frequency Micro Focused - Ultrasound
(Thermage, Titan, Accent, (Ulthera)
eMatrix, Pelleve, Exilis...)
Lasers
(Fraxel, Acclaim, Accolade, Apogee...)
Outside In
Lasers & RF
Inside Out
MF Ultrasound
CONFIDENTIAL
4. Innovative Leveraging of Ultrasound
Medical Focused
Imaging Energy
Epidermis
Dermis
Subcutaneous
+ = Tissue
Fibro-muscular
Tissue
Muscle
Coagulation
37 ˚C 45 ˚C 65 ˚C 100 ˚C
Ambient RF Micro Focused Vaporization
Body temp Ultrasound and ablation
CONFIDENTIAL
5. Innovative Leveraging of Ultrasound
Medical Focused
Imaging Energy
Epidermis
Dermis
Subcutaneous
+ = Tissue
Fibro-muscular
Tissue
Muscle
Coagulation
37 ˚C 45 ˚C 65 ˚C 100 ˚C
Ambient RF Micro Focused Vaporization
Body temp Ultrasound and ablation
CONFIDENTIAL
6. Innovative Leveraging of Ultrasound
Medical Focused
Imaging Energy
Epidermis
Dermis
Subcutaneous
+ = Tissue
Fibro-muscular
Tissue
Muscle
Coagulation
37 ˚C 45 ˚C 65 ˚C 100 ˚C
Ambient RF Micro Focused Vaporization
Body temp Ultrasound and ablation
CONFIDENTIAL
7. Coagulation with Precision at Depth
2.6mm
1.4 mm
Schlieren image of 7.5MHz focused Histology of energy deposited
ultrasound beam showing high in human cadaver skin tissue
power-density in focal region (H.J. Laubach et al, 2008)
(W.M. White et al, 2008)
• Geometrically • Localized Tissue Effect
Focused Energy • Spares Intervening Tissue
CONFIDENTIAL
9. Treatment Zones
Approximately 8,000 discrete coagulation points placed at dual depths,
causing immediate contraction and initiating the neocollagenisis
process.
CONFIDENTIAL
10. Clinical Evaluation (2006-2007)
● Pilot Safety Study
– Massachusetts Eye & Ear Infirmary (R. Gliklich, M.D.)
– 15 subjects, treat and resect study
– Safe ultrasound energy deposition – no clinical or
subclinical sequelae
– Sensory response was tolerable
– Confirmed selective thermal coagulation while sparing
epidermis
TCP’s evident 24 hrs, repaired TCP’s at 12 weeks
CONFIDENTIAL
11. Brow Lift Efficacy Clinical Study
M. Alam et al,, Northwestern University safety and efficacy study 2006.- 2007:
35 subjects, full face and neck treatments
3mm
35 Patients 1st Treatment
89%
2mm 68% 1.9mm
Lift
1.7mm
1mm
Clinical Significant brow lift = .
.5 mm 5mm
1 2 3 4 5 6 7
Months
• Quantitative Assessment - clinically significant brow lift in 89% of subjects
• Masked Assessment of Photos – clinical significant brow lift in 86% of subjects
– 2 plastic surgeons, 1 dermatologist
– 100% agreement between masked/unmasked clinicians
CONFIDENTIAL
KEY MESSAGES:\n\n Ulthera is the first and only device to receive an FDA approved indication for tissue lifting. It is unique within the category of energy-based aesthetic devices by how it works and how it performs\n\n Ultherapy offers consistent and significant results for patients with mild to moderate laxity\n\n Ultherapy offers a new category of energy-based treatment that is easily integrated into the aesthetic practice and is complementary to other treatments already being done.\n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\n In the aging skin, the dermis, begins to thin and the network of elastin and collagen fibers begins to unravel. These deep effects and other factors lead to facial skin laxity. \n\n2 different types of energy-based aesthetic technologies. Outside in and Inside Out. They work fundamentally different as to how they are able to deposit energy and at what levels of tissue. \n\n “Outside In”, like the myriad of RF products on the market today, all work in a similar fashion: they push energy in bulk from the surface through the skin and are only able to attain depths in the 2mm range. They are capped at temperatures in the 40-45 degree C range. \n\n The other “Outside In” technology are lasers. They are very precise and push energy from the surface through the skin and only attain depths around 1-1.5mm. They work great for surface issues.\n\n The differentiated technology we are here to talk about today is ours and it is the only “Inside Out” Technology. Ulthera exclusively bypasses the superficial skin and can reach depths of 4.5mm below the skin and treat into SMAS, platysma, and connective tissue. “Outside In” technologies cannot reach the depths of Ultherapy. \n
KEY MESSAGES:\n\nUltherapy uses tried and true ultrasound to visualize the layers of the skin\n\nBecause it is focused ultrasound, it uses a similar principle to what many experienced as a child using a magnifying glass to burn a leaf. Where the energy is unfocused you can run your finger underneath the magnifying lens and you won’t feel heat or burn your hand. However, where the light comes together at a focal point, the heat is generated enough to burn a hole in the leaf.\n\nSimilarly this is what is being done with the ultrasound. It bypasses the most superficial parts of the skin and thermally coagulates at focal points in the tissue 4.5mm below the surface of the skin. \n\nUlthera precisely lays down coagulation points (bypassing the epidermis and superficial dermis) within the fibro muscular layers (SMAS) at 4.5mm. Each Thermal Coagulation Point is a tiny 1 cubic mm and uniformly distanced from other points about 1.1. mm, which leaves healthy tissue about, below, and between each discrete point. \n
KEY MESSAGES:\n\nUltherapy uses tried and true ultrasound to visualize the layers of the skin\n\nBecause it is focused ultrasound, it uses a similar principle to what many experienced as a child using a magnifying glass to burn a leaf. Where the energy is unfocused you can run your finger underneath the magnifying lens and you won’t feel heat or burn your hand. However, where the light comes together at a focal point, the heat is generated enough to burn a hole in the leaf.\n\nSimilarly this is what is being done with the ultrasound. It bypasses the most superficial parts of the skin and thermally coagulates at focal points in the tissue 4.5mm below the surface of the skin. \n\nUlthera precisely lays down coagulation points (bypassing the epidermis and superficial dermis) within the fibro muscular layers (SMAS) at 4.5mm. Each Thermal Coagulation Point is a tiny 1 cubic mm and uniformly distanced from other points about 1.1. mm, which leaves healthy tissue about, below, and between each discrete point. \n
KEY MESSAGES:\n\n The middle image shows an image of our ultrasound transmitting through water. What it demonstrates is that it is unfocused at the top and only where the energy is focused (comes together) is where a thermal effect will occur. 95% of the total energy for each point is contained with 1mm cubed.\n\n The histology slide demonstrates that there is no damage surrounding the point…healthy tissue all around each, discrete coagulation point\n
KEY MESSAGES:\n\nWhen the monopolar electricity is delivered to the tissue, you see an immediate contraction of the SMAS. Observe how much contraction happens in the 20-30 times the tissue is touched here. \n\n This is essentially what is being done by Ulthera, but NON INVASIVELY. In fact, each coagulation point (approximately 8,000 per treatment!) causes similar contraction as it is deposited into the tissue.\n\n Ultherapy treatments first begin placing the energy into the deep, 4.5mm layers (typically SMAS, platysma, and connective tissue), then a second pass into 3.0mm layers (typically deep dermis). Even the 3.0mm pass is affecting a depth that other energy-based aesthetic technologies can affect. \n
KEY MESSAGES:\n\nThe Ulthera System today is indicated for treatment of the face and neck and, again, is the only technology to have an approved specific indication for tissue lifting .\n\n There is a lot of interest in where else on the body the technology can be used. Ulthera is exploring these and will promote when the appropriate approvals are attained. \n \nUlthera is a platform technology!\n
KEY MESSAGES:\n\nThere have been several articles published about the safety and efficacy of Ultherapy. We will highlight two.\n\nThe first pilot study was conducted by a team at Massachusetts Eye and Ear Infirmary (associated with Harvard University)\n\n Half of the patients underwent Ultherapy and then a facelift within 24 hours later. When extracted tissue was examined, the thermal coagulation points were observed and confirmed. \n\n The other half of the patients had an Ultherapy and then a facelift up to 12 weeks later. When extracted tissue was examined, the thermal coagulation points were not observed, but what was observed was NO scar tissue or injury evidence, just healthy tissue with new collagen growth. \n
KEY MESSAGES:\n\nThe second study was conducted at Northwestern University and the data was used to support the technology FDA submission (leading to the exclusive “lift” indication”\n\nOf note from this study:\n 89% subjects had clinically significant lift in 90 days through 12 quantitative measurements from each eye\n Additionally, masked assessment was conducted by 3 physicians and they concluded 86% subjects had significant clinical lift\n The quantitative measurement data practically matched masked physician conclusions!\n
KEY MESSAGES:\n\n-The concept of being an “Outside In” technology was already introduced. This histopathology demonstrates the concept.\n\n-With other technologies the more energy used… the deeper it is “pushed”. That is one of those technologies limitations of RF, for example. The energy cannot get hot enough to go deeper without burning the skin.\n\n-Here you see micro-focused ultrasound modeled at 2.3, 3.4, and 6.8 joules and how the energy grows back closer to the surface (instead of going deeper). With Ultherapy, the highest energy level used is 1.2 joules. \n\n-So to summarize, Ultherapy is going 4.5mm below the skin, coagulating the temperature at a range of 65-70 degrees C and all with 1.2 joules of energy. The nature of micro-focused ultrasound allows us to do this without affecting the surface. \n
KEY MESSAGES:\n\n- Light, portable, and the system contains three components: Ulthera Control Unit, Handpiece, and Transducer\n\nThe system is a PLATFORM TECHNOLOGY: changes for tissue effect, depth, etc. can be made in the transducer (and that is the direction the company R&D is heading)\n \nThe Transducers are multiple-patient use and don’t “time out” after just one patient. \n
KEY MESSAGES:\n\nThe “see and treat” capability of this system is one of the most attractive features\n\nIn this image you can see:\n 8mm depth \n 25mm across the tissue\n Bone, tissue depths\n
KEY MESSAGE:\n\nGreen Line demonstrates treatment line, with each &#x2018;hash mark&#x2019; demonstrating the approximate location of the TCPs\n<Demonstrate with pen or transducer the orientation of the transducer>\n\n-This image shows how the bone is in the path of the treatment line. It is recommended to not treat into bone.\n\nThe system then has the ability to shorten the line in order to place the energy in the connective tissue at 4.5mm and at 65 degrees C\n\nSee and Treat capability allows this technology to be predictable and the results reproducible \n
KEY MESSAGES:\n\n<Demonstrate with pen or transducer the orientation of the transducer>\n\nThis is treating submentally into the platysma\n
KEY MESSAGES:\n\n-Visualization helps knowing when/how to treat, and when not\n\nPoor coupling is poor contact between the transducer and skin caused by lack of or inconsistent gel layer\n\nToo much gel can be an issue and affect at what depth the TCPs are deposited\n\nAnd, incorrect depth transducer for a particular region. This tells the user that they should switch from a 4.5mm transducer to a 3.0mm one\n\nVisualization is at the heart of safety & efficacy and allow the user to deliver predictable and reproducible results\n
KEY MESSAGE:\n\n Ulthera is the first and only device to receive an FDA approved indication for tissue lifting. It is unique within the category of energy-based aesthetic devices by how it works and how it performs\n\n Ultherapy offers consistent and significant results for patients with mild to moderate laxity\n\n Ultherapy offers a new category of energy-based treatment that is easily integrated into the aesthetic practice and is complementary to other treatments already being done.\n
