Premier Laser Systems Receives FDA Clearance to Market Its Low Cost Aurora HL Dental Hygiene Laser
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Thursday September 30, 7:30 am Eastern Time
Company Press Release
Premier Laser Systems Receives FDA Clearance to Market Its Low Cost Aurora HL Dental Hygiene Laser
IRVINE, Calif.--(BUSINESS WIRE)--Sept. 30, 1999--Premier Laser Systems Inc. (Nasdaq/NM:PLSIA - news) Thursday announced that the Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its new, low-cost Aurora(TM) HL diode soft tissue dental hygiene laser.
The new laser is designed specifically for use by dentists and, where permitted, dental hygienists for such soft tissue procedures as sulcular debridement, a commonly performed procedure in which cleaning and disinfecting is done below the gum line.
The Aurora HL is a 1.5-watt version of the company's more powerful Aurora laser and will be marketed nationwide and overseas to dentists and to hygienists in the 33 states where regulations allow hygienists to perform the procedure. It carries a U.S. retail list price of $11,000 and will be available for purchase at the American Dental Association Conference October 9-12 in Honolulu.
The FDA clearance of Aurora HL follows the clearance earlier this month of the company's BluLaze(TM) system for teeth whitening and composite curing.
Robert Barr, DDS, a San Jose, Calif.-based practitioner with considerable laser experience, said that the FDA cleared device ``provides an easy-to-use, very affordable means by which dentists who have considered employing lasers can now introduce this state-of-the-art technology to their patients for hygienic procedures.
``The Aurora HL also enables hygienists, in the states where they can do so, to perform gum surgeries with greater patient comfort, as well as faster, better healing,' Barr said. ``Overall, this will definitely help build a first-laser practice and enhance even further those practices where higher-power lasers are already in use for soft and/or hard tissue procedures.'
Aurora HL is the second laser in the three-member family of Aurora soft tissue diode lasers to be cleared to market by the FDA. The top-of-the-line Aurora has been on the market since January 1996 and the new six-watt Aurora SL is still in the process of obtaining FDA clearance. All three lasers were shown earlier this month at the California Dental Association meeting in San Francisco.
Premier Chairman, President and CEO, Colette Cozean, Ph.D. commented, ``We are enthusiastic about the Aurora HL especially since it is designed specifically for hygiene procedures. We believe that it will fill an important need for dentists as well as hygienists and could well pave the way for the introduction of lasers into a dental practice.'
Gloria E. Monzon, RDH, a dental hygienist practicing in San Jose has been using lasers as an adjunct to traditional perio debridement for a number of years. She uses the laser for sulcular debridement, or laser curettage, to remove diseased epithelial lining and to decontaminate, or minimize, intrasulcular bacterial activity.
``With the laser, my patients experience reduced pocket depths, with little to no bleeding upon probing and more stippling than I have ever seen. The laser has greatly improved the results of my patient care,' Monzon said.
``With Aurora HL,' she added, ``there is finally a laser that will accommodate all of the hygienist's laser perio therapy needs. I believe that this addition to our instrument tray will help us effect a dramatic improvement in the dental health of our patients and, as an adjunct to the traditional method of debridement, the laser will elevate hygiene to a level beyond our current capabilities.'
Premier Laser Systems develops, manufactures and markets diagnostic and therapeutic products for the eyecare, dentistry and surgical markets including lasers, fiber optic delivery systems and associated products for a variety of applications.
The statements in this release that relate to future events or performance and statements about future sales are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to FDA clearance of components and systems, the commercial acceptance of and demand for dental laser procedures and products, the availability of components, distributors' ability to sell the product, competitors' product introductions and other risks identified in the company's SEC filings. Actual results may differ from those described in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
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