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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.' |
