BIOLASE TECHNOLOGY, INC. Receives FDA Clearance to Market New Advanced Laser Surgical System , July 24, 1997 08:33 AM
SAN CLEMENTE, Calif.--(BW HealthWire)--July 24, 1997--BIOLASE TECHNOLOGY, INC. BLTI announced today that it has received clearance by the U.S. Food and Drug Administration to market its DermaLase(TM) Er,Cr:YSGG laser system for a broad range of dermatological and general surgical applications.
"We are excited that we are now able to offer our DermaLase(TM) system to dermatologists and general surgeons as it offers many benefits to the patient," said Donald A. La Point, President and CEO of BIOLASE. "The DermaLase(TM) system can be used in a wide variety of surgical indications, including incision, excision, ablation, vaporization and coagulation of soft tissue. We believe that the proprietary technology incorporated in our DermaLase(TM) system, which combines a very effective laser wavelength with a unique air/water spray, results in improved histological effects on tissue including reduced tissue trauma and faster healing. As a result, the DermaLase(TM) system is effective for scar revision, removing tumors and cysts, performing diagnostic biopsies and skin resurfacing, to note just a few of the applications that may be performed with the DermaLase(TM) system."
Dr. Lewis R. Eversole, professor of pathology at the University of California, Los Angeles and principal investigator for BIOLASE's domestic clinical studies, stated, "The use of cool, sterilized water during the cutting process yields excellent results in dermatology, cosmetic, reconstructive, oral and general surgeries. One particular application -- skin resurfacing -- illustrates this point. Conventional laser surgery can produce skin burns that take weeks or months to heal. By contrast, skin treated with the DermaLase(TM) system heals in substantially shorter time.
"As the only laser system of which I am aware that incorporates water assisted cutting, cooling and hydration, DermaLase(TM) represents to the medical specialist a surgical tool unique, flexible and efficacious for multiple applications. In addition, DermaLase(TM) cuts precisely with minimum trauma to tissue. These characteristics should be of great interest and excitement to dermatologists and cosmetic, reconstructive, oral and general surgeons and to their patients."
BIOLASE announced that it will demonstrate the DermaLase(TM) system to surgeons and dermatologists on September 13th at the Ritz Carlton Hotel in St. Louis. In preparation for what is expected to be significant interest in the product, the Company is currently interviewing various distributors in appropriate markets and taking measures to increase production volume. The Company intends to exhibit the DermaLase(TM) system at various medical conferences throughout the country during the next several months.
BIOLASE Technology, Inc. manufactures and markets advanced medical, dental and surgical products, including laser systems, HydroKinetic(TM) surgical systems, 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 competing 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-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. |
