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FDA Grants Marketing Clearance For Biolase's Dental Laser Treatment - Update

12/9/2009 11:33 AM ET

Wednesday, dental laser company Biolase Technology, Inc. (BLTI: Quote) said it received 510(k) clearance from the U.S. Food and Drug Administration to market its Waterlase MD laser system for removal of subgingival calculi to prevent and treat periodontitis.

Periodontitis is the greatest cause of tooth loss for adults over 35 and a condition impacting more than half of Americans over the age of 55, according to the American Academy of Periodontology. Subgingival calculi, which is commonly known as plaque formation, is the cause of periodontitis and is very hard to remove with a toothbrush alone once formed.

Biolase said its Waterlase MD system uses its patented YSGG laser energy, which gently removes unwanted calculus deposits while preserving healthy tooth structure. In order to manage and treat periodontal disease, the conventional method is to remove calculus by scraping with a hand instrument or using ultrasonics. These methods can remove healthy tooth structure in the process. Biolase's system offers long-term benefits as it controls inflammation and the disease without removing the healthy tissue required for regeneration and healing, the company said.

Waterlase MD enhances the Deep Pocket Therapy with New Attachment using the Biolase-patented Radial Firing Perio Tips, a minimally-invasive alternative to traditional, more invasive periodontal surgical treatment, the company noted. Deep Pocket Therapy with New Attachment is the procedure where Waterlase MD is applied to remove inflamed tissue and calculus deposits that lead to re-infection. This removal of calculus deposits prepares the surface of the tooth to allow new attachment with the gums, and is the final building block in a Total Periodontal Laser Solution from Biolase, the company said.

Bret Dyer, clinical assistant professor at the University of Texas at Houston's Department of Periodontology, said, "Deep Pocket Therapy with New Attachment is a whole new paradigm in the treatment of periodontal disease. In the past, periodontics has been focused on slowing the disease process down. With this procedure, we are now closer to reversing the disease than we have ever been."

David Mulder, chief executive officer if Biolase, said, "This represents yet another significant increase in the day-to-day utility of the Waterlase MD in periodontal and generalist offices alike."

The Waterlase MD system is marketed, sold, and serviced by Biolase's exclusive North American distribution partner Henry Schein, Inc. (HSIC).

BLTI is gaining $0.06 or 3% and is trading at $2.06 on a volume of 38 thousand shares on the Nasdaq.

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by RTT Staff Writer

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