Healthcare Industry News: BIOLASE
News Release - July 13, 2006
BIOLASE Announces FDA Clearance of Its OCULASE MD(TM) Laser System for OphthalmologyIRVINE, CA--(Healthcare Sales & Marketing Network)--Jul 13, 2006 -- BIOLASE Technology, Inc. (NASDAQ:BLTI ), a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market its OCULASE MD(TM) Laser System for general ophthalmic soft tissue surgical indications.
"This clearance is an important milestone in our ophthalmic pursuits, representing an early achievement along the path to developing a treatment for presbyopia. In addition, it enables us to pursue other applications utilizing our core technology in ophthalmology. And now with this clearance, we will be better able to move forward with our clinical research and sales and marketing initiatives for the Oculase MD, both domestically and internationally," commented Jeffrey W. Jones, President and CEO.
FDA-cleared indications for the OCULASE MD include the incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit. This represents the first Er,Cr:YSGG laser system cleared for ophthalmic applications.
In collaboration with David Castillejos, M.D., an ophthalmic surgeon and retinal specialist, the Company has been involved with clinical research related to ophthalmic applications over the past year. "This exciting technology of combining water and laser enhances the surgical processes and outcomes in various ophthalmic applications and is a vast improvement over traditional tools, such as the scalpel," commented Dr. Castillejos.
Daniel S. Durrie, M.D., a BIOLASE board member and ophthalmic surgeon, commented on the FDA clearance, "The OCULASE MD is an innovative device that offers broad base potential. We are looking forward to exploring additional applications of this unique technology in the field of ophthalmology."
About BIOLASE Technology, Inc.
BIOLASE Technology, Inc. (http://www.BIOLASE.com) is a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine. The Company's products incorporate patented and patent pending technologies focused on reducing pain and improving clinical results. Its primary product, the WaterlaseŽ system, is one of the best selling dental laser systems. 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(TM) system, which uses a laser to perform soft tissue and cosmetic procedures, including tooth whitening. The Company is also developing a laser for use in the field of ophthalmology.
This press release may contain forward-looking statements within the meaning of safe harbor provided by the Securities Reform Act of 1995 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 are based on management's current, preliminary expectations and are subject to risks, uncertainties and other factors which may cause the Company's actual results to differ materially from the statements contained herein, include market acceptance of the product, products liability issues, manufacturing and sales force limitations on commercialization and other risks described in the Company's reports it files with the Securities and Exchange Commission, including its annual and quarterly reports. No undue reliance should be placed on forward-looking statements. Such information is subject to change, and we undertake no obligation to update such statements.
Source: BIOLASE Technology
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