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NEWS RELEASE for December 09, 2009
BIOLASE ANNOUNCES FDA 510(K) CLEARANCE OF ITS WATERLASE MD™ LASER FOR REMOVING CALCULUS IN PATIENTS WITH PERIODONTAL DISEASE
Minimally-invasive Treatment for Condition Impacting Over Half of Americans Over 55
IRVINE, CA (December 09, 2009) – 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 Waterlase MD™ laser system for removal of subgingival calculi to prevent and treat periodontitis, the greatest cause of tooth loss for adults over 35 and a condition impacting more than half of Americans over the age of 55, per the website of the American Academy of Periodontology (AAP).
Calculus removal is a critical procedure in successfully managing and treating periodontal disease. Industry experts estimate the condition effects 25% to 50% of American adults at various levels. Cleaning the surface of the root is conventionally done by scraping with a hand instrument or using ultrasonics. However, clinical studies indicate these methods can remove a significant amount of healthy tooth structure in the process. The YSGG laser energy used by the Waterlase MD gently removes unwanted calculus deposits while preserving healthy tooth structure. According to experts, this offers long-term benefits for sufferers of periodontal disease, because it controls inflammation and the disease without removing the healthy tissue required for regeneration and healing. This new application of the Waterlase MD greatly enhances the recently announced Deep Pocket Therapy with New Attachment™ using the BIOLASE-patented Radial Firing Perio Tips™ (RFPT), a minimally invasive alternative to traditional, more invasive periodontal surgical treatment. Deep Pocket Therapy with New Attachment is the procedure where the Waterlase MD laser is applied to remove inflamed tissue that leads to re-infection, and now removal of calculus deposits to prepare the surface of the tooth for new attachment is possible. This is the final building block in a Total Periodontal Laser Solution from BIOLASE that is unique in dentistry.
“Deep Pocket Therapy with New Attachment is a whole new paradigm in the treatment of periodontal disease,” said Dr. Bret Dyer, a periodontist in Sugar Land, TX and Clinical Assistant Professor at the University of Texas at Houston’s Department of Periodontology. Dr. Dyer is the lead author of a soon-to-be-published clinical study supporting the long-term benefits of periodontal therapy with the Waterlase MD. Data in Dr. Dyer’s study was reviewed by the FDA to provide this latest clearance. “In the past, periodontics has been focused on slowing the disease process down. With this procedure, we are closer now to reversing the disease than we have ever been.”
Dyer continued, “As periodontal health is maintained over the course of patients’ lives, most will have multiple occurrences of periodontal breakdown. In the past doctors could only follow those patients until they needed surgery. But now, if they start to have breakdowns, we can perform a laser procedure with root surface calculus removal that reverses the breakdown process so those patients can avoid more invasive periodontal surgery.”
A recent periodontal patient of Dr. Dyer, who had been through several rounds of conventional periodontal surgery before having Deep Pocket Therapy with New Attachment, described his experience, “I had this procedure done about four days before Thanksgiving. I was concerned about recovery time, because I was having people over for the holiday. This procedure was a breeze. I had no problems, no complications. It was a surprise that it took less time to do the procedure and less time to get over it. I had a great Thanksgiving dinner. I didn’t have any pain whatsoever, and I’m kind of squeamish about dental appointments. I didn’t even use the prescription for pain killers the doctor gave me. The procedure only took minutes. That was a pleasant surprise in itself.”
Dr. Mark Schlesinger, a periodontist in New York, NY, explained, “This not only enhances results in the hands of a periodontist using the Waterlase MD for regenerative procedures, is also an alternative treatment for the general dentist who is treating mild to moderate periodontal cases. Patients are also more likely to accept treatment when they hear that it is minimally invasive and patients who have accepted treatment are getting positive results and avoiding the side effects that they have heard about from conventional treatment.”
Dr. Dara Rosenberg, Director, Department of Dentistry for the General Practice Residency, St. Barnabas Hospital, NY said, “This Therapy changes the environment in the periodontal pocket through removal of inflamed tissue and root surface calculus to promote healthy tissue regeneration.”
BIOLASE Chief Executive Officer David Mulder said, “This represents yet another significant increase in the day-to-day utility of the Waterlase MD in periodontal and generalist offices alike. Doctors using the Waterlase MD have already been getting more treatment acceptance and more patient referrals for their standard procedures, and for specialists and generalists who want to do more, we offer a growing list of procedures to help their patients and their practices. Our recent efforts have been very focused on periodontal disease treatment and prevention. Periodontal disease is a growing problem in an aging population, and is now being linked to greater health concerns including cardiovascular disease. For an aging population, we are very pleased to assist doctors in providing an efficient, effective, and more comfortable solution for treating periodontitis.”
The Waterlase MD 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).
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: Jill Bertotti, of Allen & Caron, +1-949-474-4300.