Articles
BIOLASE Obtains Significant New FDA Waterlase Clearance
July 11, 2001
BIOLASE Technology, Inc. (Nasdaq: BLTI - news), has received a significant new clearance from the Food and Drug Administration to market its Waterlase(TM) dental laser for numerous additional soft tissue procedures. These procedures include sulcular debridement and implant recovery.
Sulcular debridement is the removal of diseased tissue in the treatment of periodontal disease. Periodontal (gum) disease is the number-one oral health problem, with three out of four adults needing treatment for periodontal disease at some time in their lives, according to the American Dental Association (ADA). This disease can cause loss of teeth, damage to the gums and bone if left untreated. Additionally, according to the ADA, research also suggests periodontal disease may be related to other health problems, such as heart disease, artery blockages and stroke.
Dr. Joe Travato, in private practice in New Jersey, commented, ``The Waterlase is indispensable for soft tissue management and the results are phenomenal. Performing sulcular debridement with this laser is much more comfortable for the patient, local anesthesia is usually not necessary and it can help patients avoid expensive and painful surgery.''
Dental implants are used to anchor artificial teeth into the bone. It is estimated that over 500,000 implants are placed by dentists in the U.S. annually and the number is growing. The most common causes of tooth loss leading to implant placement, according to an ADA survey, are periodontal disease, tooth decay, accidents, violence or injuries.
Dr. Robert Miller, chairman of Implant Dentistry at the Atlantic Coast Dental Research Clinic, noted, ``The Waterlase is a major improvement compared to traditional implant recovery surgery. This laser makes the procedure easier for both the doctor and the patient. It has the unique ability to cut and coagulate at the same time, it produces no post-operative swelling and results in dramatically less discomfort for the patient.''
Additional new indications for use contained in this FDA clearance include: excisional and incisional biopsies; exposure of unerupted teeth; fibroma removal; frenectomy; gingival troughing for crown impressions; gingivectomy and gingivoplasty; hemostatsis; incision and drainage of abscesses; operculectomy; oral papillectomies; reduction of gingival hypertrophy; soft tissue crown lengthening; treatment of canker sores, herpetic and apthous ulcers of the oral mucosa; and vestibuloplasty.
Jeffrey W. Jones, BIOLASE CEO and president, commented, ``We are optimistic this important clearance will further accelerate our market penetration and reinforce our dominance in dental lasers. It will increase the visibility of the Waterlase in the dental community as an important tool for soft tissue procedures in addition to its revolutionary hard tissue uses.''
Jones continued, ``According to the ADA, 48% of people aged 35 to 44 have gingivitis, which if left untreated, can turn into serious periodontal disease. Health conscious and aging baby boomers have already demonstrated a high demand for laser treatments in cosmetic surgery, laser vision correction and other medical specialties. As they learn more about the advantages of laser dentistry, we expect patients to demand the same high level of care from their dentists.''
BIOLASE Technology, Inc. (http://www.biolase.com), is an advanced medical technology company which possesses and develops advanced dental, cosmetic, aesthetic and surgical products, including Waterlase(TM) (HydroKinetic®) 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. BIOLASE is the world leader in painless hard and soft tissue dental laser technology.
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. Actual results may differ materially from those projected. 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.
For further information, please contact: Lori Parks, VP-Editorial, Elisa Keys, VP-Media Relations, or Linda Decker, VP-Investor Relations, of Porter, LeVay & Rose, Inc., 212-564-4700, for BIOLASE Technology, Inc.; or Jeffrey W. Jones, President and CEO of BIOLASE Technology, Inc., 949-361-1200.
SOURCE: BIOLASE Technology, Inc.
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