News Release
SAN CLEMENTE, Calif.--(BW HealthWire)--May 8, 1997--BIOLASE Technology, Inc. (NASDAQ:BLTI) announced today that it has begun shipment of its patent-pending Millennium(TM) system to Orbis High Tech GmbH, the largest high-tech dental distributor in Germany.
Millennium(TM) utilizes a unique laser-based, hydro-kinetic technology in which an erbium laser rapidly energizes and transforms atomized water droplets into microscopic, high-speed water particles that cut hard and soft tissues. The system provides an advanced alternative to the traditional dental drill and surgical scalpel.
"Millennium(TM) represents tremendous advantages over the dental drill, as well as improvements over conventional lasers," explains BIOLASE President and CEO Donald A. La Point. "Millennium(TM) cuts tissue as precisely as a laser, but without the thermal damage typically related to lasers and it is virtually pain-free."
BIOLASE has commenced shipping to Germany under the Orbis High Tech agreement. Orbis High Tech's minimum purchase commitment is for Millennium(TM) units valued at more than $12 million during a three-year period. Initial units have been pre-sold by Orbis High Tech.
BIOLASE currently is seeking FDA clearance to market Millennium(TM) in the United States in the areas of dentistry, dermatology and cosmetic surgery. However, full approvals for dentistry are already in place in Germany. In 1996, BIOLASE successfully conducted clinical trials at the University of Aachen in Germany to prove the efficacy and safety of Millennium(TM) for dental hard-tissue cutting and to demonstrate that no thermal damage occurs.
In addition, BIOLASE has already received the critical "CE" certification which denotes the ability to market a medical product throughout the 14 countries of the European Community (EC). The CE mark is the result of the implementation of the Medical Device Directive, which requires medical devices sold in the EC to receive certification after June, 1998.
Mr. La Point stated, "Acquiring this certification is difficult but all medical device manufacturers will need it by mid-1998, so we decided to obtain the certification now rather than later. Anyone purchasing a product with the CE mark can be certain the product has met the EC's strict safety and performance standards.
"We believe that sales in Germany will be very significant considering that the population in Germany (85 million) is equivalent to nearly one-third that of the United States and Germany boasts one of the strongest economies in the World. Germany utilizes some of the most advanced, sophisticated medical device systems in the world. We're extremely proud that Orbis High Tech selected Millennium(TM), our hydro-kinetic tissue cutting system, for hard-tissue cutting due to its reliability, speed and virtually pain-free cutting as reported by leading German clinicians."
Dr. L. Roy Eversole, professor of oral pathology at the UCLA School of Dentistry and principal investigator for BIOLASE's domestic clinical studies, has been evaluating the hydro-kinetic technology for the past 18 months. He presented the successful results of his studies and conducted a large group demonstration in February in Frankfurt, Germany at the DGL (the preeminent laser society in Germany).
Dr. Eversole stated, "There was a high level of interest and acceptance by the European dentists assembled at this meeting, where they could witness, first-hand, clinical application of the hydro-kinetic system. They were very interested to hear the findings that Millennium(TM) is safe when used in the mouth, for both soft and hard tissue cutting, and has a high degree of efficacy. Then, when they saw for themselves the speed of the cavity preparation, there was tremendous excitement."
BIOLASE Technology, Inc. manufactures and markets advanced medical, dental and surgical products, including specialized biomaterials for dentistry and other medical specialties, and products for use in endodontic applications. The Company's products incorporate new patented and patent-pending technologies that achieve results not available through other products.
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-KSB and 10-QSB. 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.
CONTACT:
BIOLASE Technology, Inc.
Donald A. La Point, 714/361-1200
or
Hilary Kaye Associates
Hilary Kaye, 714/851-5150
KEYWORD: CALIFORNIA NEW YORK
INDUSTRY KEYWORD: MEDICINE
BW0270 MAY 08,1997 |
