YOKNEAM, Israel, Oct. 27 /PRNewswire-FirstCall/ -- Lumenis(R) Ltd. (LUME.PK), a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, announced today that it has received FDA clearance to market the revolutionary new Aluma(TM) Skin Renewal System with FACES(TM) (Functional Aspiration Controlled Electrothermal Stimulation) technology in the U.S. The Aluma system is the world's first system to offer effective, predictable and virtually painless non-invasive treatment of fine lines and wrinkles.
"The market for virtually painless, no downtime wrinkle and fine line reduction is vast and growing. Aluma's unique FACES technology is not only predictably effective, but also very safe. In our initial clinical study, patients showed visible improvement of treated wrinkles after a single session and the effect remained during follow up. In this study, 85% of patients showed visible wrinkle improvement at the 6-month follow up, and more than half of the subjects showed moderate to complete improvement of the skin's smoothness and appearance. The end result is nearly every patient expressed satisfaction with their treatment outcome. Unlike older technologies, physicians can delegate the procedure with confidence to trained staff members. This makes the system ideal for dermatology and plastic surgery practices, as well as cosmetic practices in OB/GYN, Family Practice and other specialties," commented Avner Raz, Lumenis President and Chief Executive Officer. "Earlier this month we launched the Aluma at the European Academy of Dermatology and Venereology Annual Congress in London (UK), and are equally excited to bring this breakthrough technology to the U.S. market. The Aluma will be available as both a stand-alone device and as a module to our multi-technology Lumenis One(TM) platform -- proof of our continuing commitment to the 'infinity' platform concept."
Aluma(TM) Skin Renewal System with FACES(TM)
Aluma's groundbreaking FACES technology combines radio frequency energy with vacuum to allow superficial as well as deep dermal heating for effective treatment, with virtually no pain and very low risk of adverse events. The vacuum-assisted bipolar radio frequency handpiece folds the skin and positions it in tight contact with the electrodes, placing the dermis in direct alignment with the energy. Special alignment of the electrodes enables RF energy to meet dermis impedance, which results in a uniform, contained zone of heating for collagen contraction and renewal with little to no discomfort.
"The Aluma truly represents a leap in radio frequency technology. We have bypassed older technologies, which can be extremely painful and only effective on less than 50% of patients, to a treatment where nearly every patient experiences improvement and only feels gentle warming of the skin," said Dr. Michael Gold, clinical investigator on initial studies of the device. "The Aluma represents a great opportunity for physicians. In my practice, using a different device for a 1.5 - 2 hour procedure, with an expensive consumable tip and pain medications that can disable the patient for the entire day, can cost the patient significantly more and has only limited appeal. The ability to provide satisfactory wrinkle reduction using the Aluma in a series of about five quick, virtually painless treatments for a reasonable cost is much more marketable to my patient base," added Dr. Mitchel Goldman, another clinical investigator of the Aluma. "It's a win-win for both the patient and the practice."
About Lumenis
Lumenis is a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications. The Company offers a wide range of products along with extensive product support systems including training, education and service. Lumenis invests heavily in research and development to maintain and enhance its leading industry position. The Company holds numerous patents worldwide on its technologies. For more information about Lumenis and its products, log onto http://www.lumenis.com
Investors: Lauri Hanover 1-866-232-6803 972-4-959-9122
The statements in this press release that are not historical facts are forward-looking statements which are subject to risks and uncertainties. The Company's actual results could differ materially from those anticipated in the forward looking statements based on a variety of factors, including, among others: uncertainties with respect to market acceptance of the Company's products, the implementation and outcome of our Turnaround Plan, obtaining regulatory approvals for new products or for the sale of existing products in new markets and enforcement of intellectual property rights; risks associated with competition and competitive pricing pressures, economic conditions generally, the Company's international operations and the Company's ability to integrate its operations with those of acquired businesses; the outcome of the Securities and Exchange Commission investigation (including the Wells Notice recently received in which the staff indicated its intention to recommend that a civil proceeding be brought seeking, among other things, injunctive relief and civil monetary penalties) and several securities class action lawsuits to which the Company is subject and the outcome of the investigation conducted by the Audit Committee; uncertainties relating to the Company's continuing liquidity; and other risks detailed from time to time in the reports filed by Lumenis with the SEC, including its annual report on Form 10-K and quarterly reports on Form 10-Q.
Lumenis Ltd.CONTACT: Investors: Lauri Hanover, 1-866-232-6803, +972-4-959-9122
Web site: http://www.lumenis.com/
