SOURCE: BIOLASE Technology, Inc.

September 06, 2005 07:00 ET

BIOLASE Announces 510k FDA Submission of Its OCULASE MD™ for Ophthalmology

SAN CLEMENTE, CA -- (MARKET WIRE) -- September 6, 2005 -- BIOLASE Technology, Inc. (NASDAQ: BLTIE), a medical technology company that develops, manufactures and markets lasers and related products for dental and medical applications, announced today that the U.S. Food and Drug Administration (FDA) is reviewing its regulatory submission related to the marketing clearance for the OCULASE MD™ laser, designed to perform various indications for use in the fields of ophthalmology and oculoplasty.

The indications requested are for general tissue ablation, anterior capsulotomy (cataract removal), skin resurfacing, and treatment of wrinkles of tissue surrounding the eye and orbit. The Company has been conducting clinical research initiatives and multiple research projects related to its ophthalmic development over the past year in the field of ophthalmology and oculoplasty.

"We are looking forward to our market approval in the field of ophthalmology and are excited to leverage our core technology to other medical specialties. This 510k submission represents a significant milestone for the Company and its ophthalmic efforts," commented Robert E. Grant, President and CEO.

About BIOLASE

BIOLASE Technology, Inc. (http://www.biolase.com) is a medical technology company that designs, manufactures and markets proprietary dental laser systems that allow dentists, oral surgeons and other specialists to perform a broad range of common dental procedures, including cosmetic applications. The company's products incorporate patented and patent-pending technologies focused on reducing pain and improving clinical results. Its primary product, the Waterlase® system, is the best-selling dental laser system. The Waterlase® system uses a patented combination of water and laser to precisely cut hard tissue, such as bone and teeth, and soft tissue, such as gums, with minimal or no damage to surrounding tissue. The company also offers the LaserSmile™ system, which uses a laser to perform soft tissue and cosmetic procedures, including tooth whitening.

This release may contain forward-looking statements that are based on the current expectations and estimates by our management. These forward-looking statements can be identified through the use of words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," "may," "will," and variations of these words or similar expressions. Forward-looking statements in this release include statements regarding BIOLASE's expectations with respect to its pending 510k clearance of its OCULASE MD™ laser. These statements speak only as of the date hereof, are based upon the information available to us now, are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of a number of factors including, but not limited to, the determination by the FDA regarding the Company's 510k pending regulatory submission. Such information is subject to change, and we undertake no obligation to update such statements.

Contact Information

  • For further information, please contact:
    Robert E. Grant
    President & CEO

    John W. Hohener
    Executive Vice President and CFO

    Scott Jorgensen
    Director of Finance & Investor Relations

    BIOLASE Technology, Inc.
    +1-949-361-1200