The new generation of home-use devices incorporates advanced technologies such as phototherapy, radio frequency (RF), ultrasound, and so on, and therefore requires FDA clearance to market, supported by rigorous clinical studies demonstrating the safety and efficacy in the intended application. Leading devices that meet these criteria, both available and under development, are shown in Table 25.2.
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Table 25.2 Next Generation Home Aesthetic Devices
Source: Medical Insight, Inc. |
As of mid-2007, few of these were available. One exception to this was a set of home-use devices offered by Israel-based Radiancy. A leader in the professional aesthetic device market, Radiancy manufactures equipment that delivers Light-Heat Energy (LHE), a proprietary technology utilizing thermal energy (heat), as well as photothermolysis to achieve intended effects.
In the home-device market, Radiancy was an early pioneer with the introduction of its No! No! hair-removal device. First launched in 2004, the system uses a patented proprietary technology that Radiancy calls “thermicon.” In this process, thermal energy is delivered to the hair follicle with a high-temperature thermodynamic wire that glides just above the skin and singes hair at the skin surface, while conducting thermal energy through the hair shaft down the follicle. Heat energy from the device, transiently stored in the hair shaft, completes the thermolysis process. An electromechanical system monitors the device’s movement over the skin and controls energy delivery; when the sensors detect that the device is being moved too slowly, heating of the wire stops, and a mechanical mechanism rapidly raises the heating wire away from the skin. Radiancy says that such repeated treatments weaken the hair follicle and lead to reduced hair growth. In clinical studies, women who used the device two to three times per week on various body areas experienced a sustained 48% average reduction in hair count after six weeks of use. Studies show these results to be as efficacious and safe as professional light-based systems.
Consumer response to the No! No! has been strong. In May 2006, Radiancy’s distributor in Europe ran a trial late night television commercial to test consumer interest. The launch of the product via televison sales was later expanded to retail, where, according to the company, during the first week of the test, 10,000 units were sold. By September, more than 100,000 orders had been taken in Spain alone with a run rate of 20,000 devices per week. The unit is priced at $250 to $300, with replacement heads (which are required roughly every 2 months) priced at $10. No! No! is currently available in Chile, Mexico, Argentina, Peru, Uruguay, Spain, Portugal, Germany, Greece, Belgium, Australia, Taiwan, Korea, and the United States, with another 12 planned launches by the end of 2007. More than 700,000 devices have been sold as of May 2007, according to Radiancy’s President and CEO, Dr. Dolev Rafaeli.
Two other home-use devices incorporate a modified version of the LHE (a proprietary and patented combination of Light-and-Heat Energy) technology that Radiancy calls LHE Micro Phototherapy. This adaptation utilizes lower-energy fluence, providing greater safety for consumer use. The Facial Skincare Device (FSD) was cleared in 2006 by FDA for skin rejuvenation, and Clear Touch Lite (CTL) was cleared in 2006 for acne treatment. Both are being sold worldwide. The FSD is a continuous pulsed-light system that delivers light in the 400-1200 nm wavelength range to a large 14 mm x 27 mm spot-size treatment area. Fluence ranges from 6 to 12 J/cm2 with 1.6 ms pulse duration. The 2.8 lb device is easily held in the hand, and plugs into a standard electrical outlet. Radiancy says the FSD (which is also called Facial Toning Device or FTD outside the United States) can stimulate collagen production to soften fine lines, homogenize skin tone, decrease pore size, and improve skin texture. Similarly, the CTL is a continuous pulsed-light system that delivers light in the 430 nm-1100 nm wavelength range with a 14 mm x 27 mm spot size. Fluence is 6 J/cm2 with a 1 ms pulse duration. It weighs 2.2 lb and plugs into a standard electrical outlet. Like Radiancy’s professional acne-treatment devices, CTL helps reduce the appearance of inflammatory acne lesions.
Radiancy also has other home-device product initiatives.
In Asia, two companies currently sell laser systems for home hair removal: Spectragen – ics and Ya-Man.
Although Spectragenics is relatively new, its founders have a long history in the aesthetics industry, having developed the highly successful and technologically innovative LightSheer diode laser for professional hair removal in the early 1990s. They subsequently sold the technology to Palomar Medical, and Palomar divested to Coherent Medical, which in turn merged with ESC to form Lumenis. LightSheer remains one of the industry’s top-selling professional laser hair-removal systems, although Spectragenics focuses entirely on the emerging home market, selling a diode laser home hair-removal device in Japan. Available for roughly three years, the product generated approximately $3.0 million in sales in 2006. The company is working to expand distribution for the i-epi, but as of July 2007, the product had not obtained clearance to market either in the United States or in Europe.
Tokyo-based Ya-Man offers a variety of home-use devices for skin care, hair care, and analysis of body fat. Founded in 1969, the privately held company was the first Japanese manufacturer to introduce professional electrolysis for hair removal in Japan. With more than 400 patents pending, Ya-Man’s technology-based products are sold worldwide in retail stores, salons, mail order, and television shopping channels. Ya-Man has introduced a light – based home hair-removal device in Asia, and is expected to eventually obtain FDA approval to sell the product in the United States.
Palomar Medical Technologies, one of the industry’s oldest manufacturers of professional aesthetic laser equipment and an early technology pioneer, is also working on a home-use device for hair removal. In February 2003, Palomar signed a development agreement with razor maker Gillette (which has since been acquired by Procter & Gamble), wherein Gillette would provide $7 million in funding and work with Palomar over a 30-month period to develop a patented self-use device for women. In June 2004, the companies extended their relationship, with Gillette agreeing to fund a further $2.1 million through a planned project completion in August 2006. The collaboration extends Palomar’s own efforts to develop a home-use hair-removal device, which date back to the late 1990s. In December 2006, Palomar announced that FDA had cleared its home device for marketing. While the product had not been introduced as of mid-2007, a high-profile launch is expected shortly that will draw national attention to these new types of devices.
In February 2007, Palomar and Gillette extended their agreement to develop an additional home use, light-based hair-removal device for women. Under the 11-month agreement, Gillette will provide Palomar with development payments of $1.2 million and an additional $300,000 upon the completion of certain deliverables.
Palomar is also working with Johnson & Johnson to develop home-use devices for skin rejuvenation, acne treatment, and cellulite reduction. In September 2004, the two companies signed an agreement wherein Johnson & Johnson would fund development and then (presumably) market a product upon FDA approval. While the program is ongoing, Palo – mar has not publicly released any details regarding its progress.
Texas-based Tyrell was founded in 2002 to market a novel device for home treatment of acne. The company’s product, Zeno, utilizes proprietary ClearPoint technology to kill acne-causing bacteria. It does this through the delivery of precisely controlled heat in a replaceable treatment tip that heats to 118.5 degrees. In one clinical trial, 90% of pimples treated with the device demonstrated improvement or resolution within 24 hours. When Zeno was first launched in 2005, it was sold exclusively through dermatologists’ offices and medispas. The following year, however, Tyrell introduced two new versions, Zeno PRO and Zeno MD, which contained higher treatment counts. The full product line now includes original Zeno, a 60-treatment count device priced at $149; Zeno PRO, a 90-treatment count device with carrying case priced at $185; and Zeno MD, a 150-treatment count device with carrying case costing $200. The new models also feature new product colors.
Photo Therapeutics Limited, a UK-based company, is also getting ready to launch an advanced home-use device. Like its professional equipment, the company’s home device would be based upon light emitting diode (LED) technology to stimulate collagen regeneration. Photo Therapeutics’ President, Sue D’Arcy, says that its first device will address skin rejuvenation and acne, with a scheduled launch in 2007. It will be priced at few hundred dollars and will be distributed by a group of marketing partners. The company is also planning to investigate the ability of its home-use device to address cellulite. Photo Therapeutics has obtained FDA approval for a similar home-use product for wound healing.
Although it is still a relatively young company, Syneron has quickly established a leading position in the market for professional light-based aesthetic devices with a series of multifunctional platforms that combine the company’s unique broad spectrum light/ bi-polar RF (ELOS) technology. The devices address all the leading aesthetic applications, including hair removal, skin rejuvenation, skin tightening, acne reduction, treatment of vascular lesions, removal of tattoos, and pigmented lesions, as well as body shaping and skin tightening.
In early 2007, the company announced a partnership with Procter & Gamble (P&G) to develop skin-rejuvenation products for the home market, and is currently conducting early stage clinical studies with a prototype device. Syneron will be responsible for product development while P&G will handle marketing and distribution. Although P&G will ultimately set the prices, Syneron has stated that the device will probably be priced less than $500 and there could be a disposable component.
Aesthera, the technology pioneer which developed photopneumatic therapy for professional aesthetic treatment, is also working on a home-use device. Company president Alon Maor says a home system would use photopneumatic technology, but unlike other home units, would not merely represent a scaled-down version of professional devices. As of mid-2007, the company has demonstrated proof of concept and has submitted data in pursuit of intellectual property protection. Its first application will be treatment of the skin in a comprehensive procedure that Maor says goes beyond skin rejuvenation to address both medical and cosmetic deficiencies. The company expects to begin commercialization toward late 2008 or early 2009; devices would be priced at “a few hundred dollars” and as with Aesthera’s professional systems, would include a disposable component.
Photopneumatic technology combines broadband light with pneumatic (vacuum) energy; the vacuum stretches the skin, increasing its surface area as well as the amount of energy transmitted to the target. This enables treatment for hair removal, skin rejuvenation, reduction of pigmented lesions, and vascular lesions that the company says is uniquely safe, painless, and up to seven times faster than conventional light-based hair-removal therapies.
Candela is one of the oldest and most established aesthetic laser companies, with a broad range of professional products that address hair removal, skin rejuvenation, skin tightening, acne reduction, treatment of vascular lesions, as well as removal of tattoos, and pigmented lesions. The company’s interest in the home-use market is relatively recent but its significant resources could lead to the quick development of a product.
In March 2007, Candela acquired Inolase, a developer of Serenity Pneumatic Skin Flattening (PSF) technology. This technology allows painless, more effective, and safer laser and intense pulsed light (IPL) treatments even at high energy levels. The PSF provides multiple advantages in a single step: painless treatments by activation of a natural pain blocking mechanism; blood expulsion from treatment zone for better light penetration, and improved efficacy; no erythema. The PSF’s vacuum system works with or without gel, and can be mounted on any laser/IPL handpiece for fast and convenient operation. Candela has indicated that this approach may have applications in professional as well as home-use devices. The company appears to be committed to this application, reportedly allocating $10.5 million of the $16.8 million it paid, to acquire Inolase to “goodwill” associated with the technology’s applicability to home use.
Spun out of medical ultrasound developer Guided Therapy Systems, Ulthera is focused on ultrasonic body-shaping devices for the professional market. The company has developed the Ultrasite GT Device, a platform of ultrasound instrumentation that utilizes disposable probes to apply energy below the skin’s surface, while sparing the intervening tissue such as the epidermis. The depth and precision of energy deposition is reportedly unprecedented, and the device’s imaging capability provides a significant advantage over alternative technologies. Ulthera is expected to introduce its first professional product in 2008, and its researchers are also working on a smaller home-use device which would be launched after the professional system. To launch this product, another company has been spun out from the Guided Therapy Systems group.
Xthetix will focus on commercial applications of Ulthera’s technology for the home market. The company’s first product will be for acne treatment and prevention, says Ulthera’s President, Brian O’Connor. It has the ability to prevent the occurrence of acne by inhibiting sebaceous gland function, using heat, he says, without undesirable side effects. Additional devices in the pipeline target skin rejuvenation, hair removal, and inflammation – related skin diseases such as rosacea. Like Ulthera’s professional device, home-use units produced by Xthetix will include both platforms and disposable components.