IRVINE, CA -- (Marketwire) -- 04/16/09 -- BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ezlase(TM) diode laser system for therapeutic applications including temporary pain relief. The cleared indications are broad to cover medical and dental.
The FDA has given clearance for the ezlase for the following indications: "The ezlase(TM) diode system emits energy in the near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle."
Dr. Dara Rosenberg, DDS, Director, Department of Dentistry at Bronx, NY-based St. Barnabus Hospital, has performed multiple pilot studies with low level laser therapy using a BIOLASE diode laser for myofacial pain and temporomandibular joint (TMJ) dysfunction on patients who have few treatment options left. TMJ syndrome is a painful misalignment of the jaw and mandible that affects more than 10 million Americans.
"Outcomes have been very positive over the years," said Rosenberg. "These chronic conditions can now be managed non-invasively and non-pharmacologically. Our clinical experience with the laser has shown improvement in both pain relief and return to function. It has enabled patients who have been on medication for extended periods of time to reduce, and eliminate the medications and avoid surgical intervention. Because it is non-invasive, more practitioners should expand its use for the benefit of all patients."
BIOLASE Chief Executive Officer David Mulder said, "This represents a significant increase in application of our diode technology and ultimately an opportunity to increase sales of our ezlase systems worldwide, strengthening our position in the diode laser market. We now have the only dental diode laser system that is cleared for soft tissue procedures, teeth whitening and pain relief. This is yet another milestone towards our goal of increased patient satisfaction, improved outcomes and enhanced practice profitability, positioning our laser systems as the instruments of choice among practitioners and patients."
The ezlase system is marketed, sold and serviced to dental professionals by the Company's exclusive North American distribution partner and growing international partner Henry Schein, Inc. (NASDAQ: HSIC).
In addition to dental applications, the new FDA clearance opens the door to market the system for a range of non-dental pain relief applications, including sports medicine, orthopedics, physical therapy and chiropractics. BIOLASE is in discussions to determine the best approach to market the laser system for these new applications.
BIOLASE received initial FDA 510(k) clearance to market ezlase, a hand-sized, state-of-the-art, feature-rich system, in early 2007 and received additional 510(k) clearance for tooth whitening using ezlase in December 2008. More information and images of the ezlase can be found on the Company's website at www.biolase.com/ezlase.
About BIOLASE Technology, Inc.
BIOLASE Technology, Inc. (http://www.biolase.com), the world's leading dental laser company, is a medical technology company that develops, manufactures and markets lasers and related products focused on technologies that advance the practice of dentistry and medicine. The Company's products incorporate patented and patent pending technologies designed to provide clinically superior performance with less pain and faster recovery times. BIOLASE's principal products are dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. Other products under development address ophthalmology and other medical and consumer markets.
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, and are 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.
For further information, please contact:
Allen & Caron