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Company Press Release
SOURCE: BIOLASE Technology, Inc.
BIOLASE Receives FDA 510(K) Clearance for SkinLaser System Recently Acquired From Laser Skin Toner, Inc.
Company Begins Marketing SkinLaser System, Immediately, Available to Consumer Via Doctors by Early 1999
SAN CLEMENTE, Calif., July 15 /PRNewswire/ -- BIOLASE TECHNOLOGY, INC. (Nasdaq: BLTI - news), an international provider of advanced cosmetic, medical, dental and surgical products, announced today that it has received general 510(k) clearance for the SkinLaser System(TM) acquired from Laser Skin Toner, Inc. and will immediately
commence marketing of this exciting new system to dermatologists, plastic surgeons and gynecologists.
''This gives us the green light to proceed with the marketing and sales for this unique technology. I anticipate that the medical community will begin receiving the SkinLaser System
later this year, accordingly, the consumer may see it as early as the first quarter of 1999'' said Donald A. La Point, President and CEO of BIOLASE Technology, Inc. He added that the Company has ''been receiving calls from surgeons throughout the country, and from people as far away as Europe and Asia. Healthcare professionals in the field of skin resurfacing are excited to know more about this method that is less traumatic and painful to the patient. We are delighted that we can now proceed to the marketing phase of this
System.''
The SkinLaser System became the fourth in BIOLASE's product portfolio last week when BIOLASE acquired the assets of Laser Skin Toner, Inc., located in St. Louis, Missouri and Rydal, Pennsylvania, in a stock transition deal. ''The System becomes a part of our new Aesthetic Division which includes our patented DermaLase(TM) HydroKinetic(TM)
System and Lazer(TM) ToothBrush, our tooth-whitening system. It will enable us to meet a broad range of needs in the aesthetics industry,'' said Federico Pignatelli, Chairman of the Board of BIOLASE. ''Specifically, SkinLaser technology focuses laser energy to the underlayer (dermis) of the skin. Patients then experience skin tightening without significant damage, burning, redness or cuts to the surface (epidermis). The potential for infection is significantly reduced and the recovery time may be shortened to a day or two for most patients. Conventional skin resurfacing laser procedures cause a considerable surface burn, may be painful to the patient and may require several weeks for recovery.''
''We undertook the development of this technology to provide patients with the benefits of skin resurfacing, but without many of its associated problems.'' said Francis O'Donnell, M.D. who, along with Terry A. Fuller, Ph.D., founded Laser Skin Toner, Inc. in 1996. Dr. Fuller commented, ''In clinical trials currently underway, the Company is investigating the use of this technology for facial rejuvenation and also for reduction of stretch marks, which are so common in childbearing and post-weight loss patients.''
According to Dr. O'Donnell, ''The mechanism of action by the laser is believed to be the stimulation of new collagen and elastin growth without significant damage to the overlying
epidermis.'' The Company has initiated an FDA sanctioned study to evaluate the safety, effectiveness and mechanism of action for its technology to tighten skin, and for the treatment
of wrinkles and stretch marks.
BIOLASE Technology, Inc. manufactures and markets advanced cosmetic, medical, dental and surgical products including its HydroKinetic surgical cutting systems and other traditional laser systems, and develops specialized biomaterials for dentistry and other medical specialties. The Company's products incorporate new patented and patent-pending technologies that achieve unique results.
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.
See the Laser Skin Toner, Inc. Web Site at www.lcdevc.com. |
