BB&T Contributing Editor
MIAMI BEACH, Florida – The 68th annual meeting of the American Academy of Dermatology (AAD; Schaumburg, Illinois) drew a record crowd of more than 19,000 people to a program that featured an expanding array of devices used for aesthetic applications. This may portend an improving economy as many of these products are used to perform procedures which are not reimbursed by insurers. The sunny climate was also a draw after a long and record-setting winter.
Focus on the increasing incidence of melanoma
The diagnosis and treatment of melanoma, the most serious form of skin cancer, was a featured subject at the conference. In 2009, 68,720 people were diagnosed with melanoma, and according to the American Cancer Society, melanoma was responsible for an estimated 8,650 deaths in the U.S. Its incidence is increasing worldwide. It is the most common form of cancer in adolescents and young adults 15-29 years old. Darrell Rigel, MD, clinical professor of dermatology at New York University Medical Center (New York) observed that the incidence of melanoma is based on reports from hospitals. Melanoma is the only major cancer for which the diagnosis is mostly made in an outpatient setting. Rigel, therefore, believes that its incidence is underreported, especially with the trend shifting to outpatient health care. Indoor tanning beds and lamps were implicated in causing melanoma. Depletion of the ozone layer may also contribute to the increase in melanoma incidence because it allows more UVB radiation to reach the earth's surface.
A range of technologies are available for the early diagnosis of potentially deadly disease and include dermoscopy, reflectance confocal microscopy, full-body photography and mole mapping. Based on preliminary data, gene profiling is a new research area which may play a role in the clinical evaluation of melanoma.
Harold Rabinovitz. MD, a professor in the Department of Dermatology at the University of Miami Miller School of Medicine, reviewed the ABCDEs of melanoma which are used to train physicians, medical personnel and the general public on how to recognize early melanoma (Table 1). Rabinovitz said that “keeping a vigilant eye on our skin for any changes that could signal a problem is an irreplaceable first step in the process.“
Products for diagnosing melanoma
Lucid (Rochester, New York), developer of VivaScope confocal imagers that can be used for assessing skin cancer, announced at the AAD meeting the release of VivaScope 3000, a second generation handheld reflectance confocal microscope that is designed for routine clinical use. Its 1 mm field of view is twice that of the earlier product. It allows for rapid analysis of cellular structure and its zoom function enables closer examination of individual cells. The product's 6 mm probe tip can be used for virtual biopsies of living skin. The company promotes its experience working with experts in the non-invasive diagnosis of melanoma and other skin cancers.
MoleSafe USA (Millburn, New Jersey) is an image documentation system for the early detection of melanoma that does not require FDA approval. A full set of body shots are taken to record current skin condition for use in future monitoring in addition to macroscopic and dermascopic images of any lesions or moles that meet dermatologists' criteria. Typically, a procedure takes one hour to record up to 50 individual lesions. The recorded imaging data is transmitted to a network of dermatologists who specialize in dermoscopy. They examine the images and utilize software tools to improve the efficiency of the recording process. A central database is used to store data. MoleSafe has a surveillance program where patients return annually for a new dermascopic assess of their existing moles and any new moles. Over the past 5 years the network of clinics utilizing MoleMap's technology have conducted over 160,000 procedures on 62,000 patients, imaged and diagnosed more than 2.5 million lesions and diagnosed 1.5 million melanomas. MoleSafe is a joint venture between MoleMap (Auckland, New Zealand), the original developer of this system, and U.S. physicians.
Mela Sciences (Irvington, New York), formerly known as Electro-Optical Sciences, has developed MelaFind, a non-invasive, handheld imaging device for use in the early diagnosis of melanoma. It emits light of multiple wavelengths of visible and infrared light to obtain data from images of suspicious pigmented skin lesions. The MelaFind device is connected via the Internet to a central server at Mela Sciences. The device uses classified algorithms from a proprietary database of melanomas and benign lesions. The images correspond to more than 5,000 biopsied lesions from over 3,500 patients. The information is analyzed against the company's database of melanomas and benign tumors after which a recommendation is made to the physician of whether or not to biopsy the lesion. The MelaFind device is comprised of an illuminator that shines 10 specific wavelengths of light, including near infrared bands, and a lens system composed of 9 elements that create images. The company is awaiting market clearance from the FDA.
Lasers used for many different applications
SharpLight Technologies (Rishon Le Zion, Israel) featured OmniMax. It is the first commercially available system that combines lasers (Er/YAG and Nd/YAG), radio frequency, infrared and dynamic pulse control in one platform for use in body shaping, skin rejuvenation, hair removal, and the removal of vascular and pigmented lesions. The company has filed a 510(k) and expects FDA clearance within a few months. The product will be marketed to aesthetic center.
Sciton (Palo Alto, California) has added ClearScan ALX to its line of laser and light systems for aesthetic applications. It is promoted as the next generation in Alexandrite lasers (755 nm) for permanent hair reduction. It is designed to provide maximum comfort for patients without compromising efficacy or speed. Its computer guided scanner can adjust from a single spot to a 30 mm x 30 mm scanned area to accommodate treatment locations from the upper lip to the back.
Ra Medical Systems (Carlsbad, California) exhibited its Pharos EX-308 excimer (xenon chloride) laser that delivers UVB light (308 nm) for use in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma (loss of skin pigmentation). It claims high dollar reimbursement from private insurers and Medicare under the Laser CPT codes 96920-22.
Cutera (Brisbane, California) featured Pearl Fusion, a single-treatment product that combines its Pearl Fractional ablation laser and its Pearl skin resurfacing laser (both at 2790 nm) that is used for deep wrinkle reduction, removal of pigmented lesions, reduction of pore sizes and the smoothing and softening of skin.
Palomar Medical Technologies (Burlington, Massachusetts) exhibited Artisan, a new integrated system for facial rejuvenation that combines pulsed light (500-600 nm and 870-1200 nm) with a non-ablative (1440 nm and 1540 nm) and ablative (2940 nm) fractional laser. Applications include removal of vascular lesions such as rosacea and spider veins, melasma, age spots and other unwanted pigmentation. Palomar recently received FDA clearance for its LUX1540 fractional non-ablative laser handpiece for the treatment of striae (stretch marks). It expands the range of applications for the Lux1540 which include the treatment of surgical scars, acne scars, melasma and non-ablative skin resurfacing.
DEKA (Calenzano, Italy/San Francisco) markets the SmartXide DOT CO2 fractional laser for skin resurfacing, plastic and aesthetic surgery. It uses the company's proprietary SmartPulse pulsed emission technology and SmartStack algorithm to optimize the scanning of the treatment area and minimizes the local increase in temperature. Treatment parameters with SmartXide DOT range from fractional, superficial and delicate. SmartPulse allows for carefully controlled energy pulses. The company also markets Minisilk FT which uses intense pulsed light for hair removal and vascular photorejuvenation, and a long-pulse Nd/YAG laser for hair removal, vascular treatments, removal of pigmented lesions, treating acne, and ablative and non-ablative skin rejuvenation.
Solta Medical (Hayward, California) is continuing its expansion plans with its recently announced acquisition of Aesthera (Pleasanton, California) which markets the line of Isolaz photopneumatic therapy devices for the treatment of acne, skin rejuvenation and hair removal. Solta's other product lines are Thermage which uses capacitive coupling in a non-invasive monopolar radiofrequency procedure for skin tightening and contouring and Fraxel which uses fractional laser technology in a minimally invasive procedure for skin resurfacing. Stephen Fanning, president/CEO and chairman of Solta, defined the company's strategy for growth as the pursuit of branded products sold to dermatologists or plastic surgeons with gross profit margins greater than 60% and recurring revenue of at least 35%.
Aesthetic devices for home-use
LEDs used in phototherapy devices are the fastest growing segment of commercial LED use. The devices range from handheld consumer products to large floor models used by dermatologists, cosmetologists and dentists. Photodynamic therapy devices for hair restoration, skin wrinkle removal and acne/blemish treatment are finding their way into retail stores.
Pharos Life (Cambridge, Ontario) markets the Tanda blue LED light therapy system (414 nm) to kill acne-causing bacteria and the Tanda red LED light therapy (660 nm) for anti-aging by reducing lines and wrinkles and to improve skin texture and firmness. The products are marketed to medical spas and to physicians for sale to patients and have a retail price of $299.
LightStim International (Lake Forest, California) markets to physicians, medipas and aestheticians handheld LED light therapy devices which may be then sold to consumers for home-use. A combination of red and infrared light is used for reducing cosmetically induced bruising and pain in the face, such as occurs after injection with dermal fillers and Botox or from skin resurfacing treatments. Its blue light therapy device is used for treating acne. Its skin anti-aging device uses a combination of red, infrared and amber light. Each of these devices sells for $350.
Lexington International (Boca Raton, Florida) sells the HairMax LaserComb, a handheld phototherapy device using a red light source from a 3R cold laser (655 nm). The product received market clearance via a 510(k) submission in 2007 for use in promoting hair growth in males with androgenetic alopecia (male pattern baldness). It is sold over the Internet or from a physician's office.
Lerner Medical Devices (Los Angeles) introduced Levia, a new class of personal targeted phototherapy for home-use under the direction of a physician. It is used for the treatment of scalp and small area psoriasis, vitiligo, eczema and seborrhetic dermatistis. The device delivers UVB light (290-320 nm) and has two different beam delivery attachments, the LiteBrush for scalp psoriasis and LiteSpot for the skin. Levia has a patient controlled touchscreen and a built-in treatment regimen prescribed by a physician. The product sells for $3,400. The company anticipates receipt of third-party reimbursement of 80% of the cost.
Ultrasound and RF-based aesthetic procedures
Sound Surgical Technologies (Louisville, Colorado) launched MedSculpt, a non-invasive ultrasound and massage system for use pre- and post-liposuction procedures. Its computerized system has handpieces for patented elastomeric massage, ultrasound physiotherapy and zonal massage. The system sells for under $70,000. It complements the company's VASER Lipo System that uses ultrasound energy to emulsify fat for body contouring.
Ulthera (Mesa, Arizona) featured its Ultherapy system that combines visualization beneath the skin's surface and non-invasive delivery of ultrasound energy at depths that enables lifting and tightening of the skin. It is the only ultrasound therapy for facial rejuvenation. The company received FDA clearance for the Ultherapy system in September 2009 for a non-invasive eyebrow lift and began marketing the product in the U.S. in December 2009. It is also sold in foreign markets. The system is priced at about $70,000
UltraShape (Yoqneam, Israel/San Ramon, California) markets Contour I Ver3 system in 57 countries and is awaiting FDA market clearance. The equipment utilizes Vertical Dynamic Focus (VDF) non-thermal focused ultrasound and RFVac radio frequency for non-invasive selective fat reduction and body contouring. It employs a 3-dimensional computer guided tracking system and is recommended for three treatments. The company announced in January 2010 the introduction of a multi-application platform that includes VDF and RFVac radio frequency with an integrated vacuum system, in an upright mobile device.
BTL Industries (Prague, Czech Republic/Clark, New Jersey) markets aesthetic devices as well as products for physiotherapy, cardiology and pneumology. The BTL aesthetic medicine division offers technologies for dissolving fat, skin tightening, and for treating cellulite and wrinkles. Exilis, its flagship product, simultaneously delivers radio frequency and ultrasound energy with contact cooling via a single applicator for use in reducing fat deposits and tightening skin. A safety feature is the ability to monitor temperature during therapy. The company started marketing Exilis in the U.S. in December 2009
Liposonix (Bothell, Washington), a subsidiary of Medicis (Scottsdale, Arizona) markets its high intensity focused ultrasound system in Canada and Europe. Approval in the U.S. is expected in 2011. The Medicis Restylane-L and Perlane-L hyaluronic acid-based dermal fillers have been formulated to contain 0.3 % lidocaine and were approved in January 2010. Similarly, Allergan's (Irvine, California) Juvederm was reformulated to contain lidocaine as was Hydrelle from Coapt Systems (Palo Alto, California) which entered the market in July 2009 and Prevelle Silk from Mentor (Santa Barbara, California), a subsidiary of Johnson & Johnson (New Brunswick, New Jersey ) which received FDA approval in March 2008. Sanofi Aventis (Paris) markets the Sculptra Aesthetic dermal filler comprised of poly-L-lactic acid. It does not contain lidocaine, nor does Radiessé, a calcium hydroxyapatite microsphere formulation from BioForm Medical (San Mateo, California) which was acquired in January 2010 by Merz (Frankfurt, Germany).
Scar Therapy Products
Several companies showed products for the treatment of various scar types including keloid, hypertrophic, surgical and traumatic (burn) scars. Biodermis (Las Vegas) exhibited its line of silicone-based products including EpiDerm gel sheeting, Xeragel ointment, Pro-Sil solution and Epifoam. ScarHeal (Madeira Beach, Florida) displayed RejuvaSil liquid silicone gel, ScarFx silicone sheeting, and Scar Esthetique crème which contains 23 ingredients. Advanced Bio-Technologies (Suwanee, Georgia) featured its Kelo-cote silicone scar gel and bioCorneum silicone crème with SPF 30 for UVA and UVB protection.