Medical aesthetics devices developer Lumenis (OTCBB:LUME) announced today that it has received FDA clearance to market its new Aluma skin renewal system in the US.
The system is equipped with Lumenis's FACES (functional aspiration controlled electrothermal stimulation) technology. FACES 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.
Lumenis president and CEO Avner Raz said, "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".
Earlier this month, Lumenis launched the Aluma at the European Academy of Dermatology and Venereology Annual Congress in London.
"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," said Dr. Mitchel Goldman, another clinical investigator of the Aluma. "It's a win-win for both the patient and the practice."
Published by Globes [online], Israel business news - www.globes.co.il - on Thursday, October 27, 2005