BLTI
Wednesday September 29, 8:05 am Eastern Time
Company Press Release
SOURCE: Biolase Technology, Inc.
Biolase Obtains FDA Clearances for New Diode Lasers
SAN CLEMENTE, Calif., Sept. 29 /PRNewswire/ -- Biolase Technology, Inc. (Nasdaq: BLTI - news) announced that it has obtained clearances from the Food and Drug Administration to market TwiLite(TM) and HyLite(TM), its new advanced technology, light weight diode lasers, for a broad range of dental cosmetic and soft tissue procedures. Biolase will market and sell these new lasers to dental practices in the U.S. through its direct sales force and internationally through its growing distribution network.
Biolase also received clearances that include indications for use in ENT, Arthroscopy, Gastroenterology, General Surgery, Dermatology, Plastic Surgery, Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery and Urology.
TwiLite(TM) is a high powered diode laser that will be marketed to dentists worldwide to perform a wide range of soft tissue procedures. General dental clearances consist of incision, excision, vaporization, ablation and coagulation of oral soft tissues. Specific procedures include pulpotomy as an adjunct to root canal therapy, crown lengthening, sucular debridement, pulpotomy, reduction of gingival hypertrophy, treatment of aptous ulcers, fibroma removal, frenectomy, gingivectomy, hemostasis and many other important procedures.
HyLite(TM) is designed to meet the strong demand for a cost effective laser to combat periodontal diseases. According to the American Dental Association (www.ada.org), ''periodontal diseases are the leading cause of tooth loss in adults. They are well recognized by the dental profession, and increasingly by the public, to be a significant health problem. Fortunately, with early detection and treatment, it is now possible for most people to retain their teeth for a lifetime. To achieve this goal, every oral examination should include an evaluation of the periodontium.''
Biolase's clearances specifically include sucular debridement. Sucular debridement is the removal of diseased or inflamed soft tissue in the periodontal pockets to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.
TwiLite(TM) and HyLite(TM) are the most advanced diode lasers available. TwiLite(TM) is equipped with robust state-of-the-art features favored by dentists. These include a ''Power-On-Demand'' foot switch that allows users to quickly increase or decrease power levels while continuing the treatment. TwiLite(TM) has the proprietary On-Board Fiber and Handpiece Management System that allows for convenient ''Pick Up and Go with No Packup.''
Jeffrey W. Jones, Biolase president and CEO, commented ''Cosmetic and painless procedures represent the most profitable and fastest growing segment of the dental market. These two new products are key to our strategy to strengthen Biolase's position and market share in the cosmetic market.'' Jones added, ''TwiLite(TM) and HyLite(TM) will also provide an important recurring revenue stream from the consumable fibers, handpieces and tips. The sale of the lasers and the consumables will allow Biolase to capitalize on our world leadership in the hard tissue laser market, increase revenues and reach our goal of profitability more quickly.''
Biolase Technology, Inc. (www.biolase.com) manufactures and markets advanced dental, cosmetic, aesthetic and surgical products, including the LazerSmile tooth whitening system (www.lazersmile.com), Hydrokinetic(TM) surgical cutting systems, and other advanced laser and non-laser based products for the professional and home consumer market. The company's products incorporate patented and patent-pending technologies in the pursuit of painless surgery (www.nopaindentistry.com).
The matters discussed in this news release include forward-looking statements which are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to, the effect of actions of third parties, including governmental officials, the timely development and acceptance of new products, the impact of competitive products and pricing, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the reports on Forms 10-K and 10-Q. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
SOURCE: Biolase Technology, Inc.
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