BIOLASE Technology, Inc. (Nasdaq: BLTI - news), a medical technology company focused on the dental laser market, today announced that it has just received the first ever FDA clearance for complete hard and soft tissue laser root canal therapy. BIOLASE can now market its Waterlase™ technology for root canal procedures for both hard and soft tissue procedures, which will broaden the applications that dentists and specialists, such as endodontists, can perform with the YSGG laser.
This clearance covers all enamel, dentin, pulpal and diseased tissue removal, shaping and cleaning aspects of root canal therapy. This includes tooth preparation to obtain access to the root canal, pulpotomy, pulp extirpation, pulpotomy as an adjunct to root canal, root canal debridement and cleaning, root canal preparation including enlargement.
``This clearance is a significant and historical milestone for the dental profession, for patients and for BIOLASE," stated Jeffrey W. Jones, BIOLASE president and CEO. ``Companies around the world have coveted and diligently worked to develop technology to improve and advance endodontics. BIOLASE once again leads the way with this monumental first."
``While BIOLASE is the dominant player in dental lasers, we do not take that position for granted. We are committed to furthering clinical advancements, improving our technology and most importantly, providing our customers with excellent support. This clearance is an important step towards achieving these objectives and it is further evidence of our superior technological and clinical expertise that we continue to lead the market with. This is part of our basis to ensure that our sales continue to grow aggressively for many years to come," added Mr. Jones.
William Chen, DMD, MAGD, commented, ``This approach to endo/root-canal therapy with the Waterlase™ is revolutionary. For performing pulpotomies, the Waterlase(TM) will either reduce or eliminate the need for anesthesia in most cases. From our case studies, it was demonstrated that there is a great advantage of patient comfort using the Waterlase(TM) and I strongly believe that there is a bactericidal effect in the canal by the laser irradiation. Correspondingly, it is my opinion that this will lead to a reduction in the need for antibiotics after treatment. Patients treated with Waterlase(TM) showed dramatically reduced postoperative pain, discomfort and swelling. I also believe the potential is very good to significantly reduce or eliminate the need for anesthesia in complete root canal therapy and in reducing the need for post-operative treatment. Past concerns of lasers heating and damaging tooth structure are no longer an issue with the Waterlase™."
According to the American Association of Endodontists (AAE), ``More than 14 million root canal procedures are performed every year. Endodontic treatment, often referred to as root canal treatment, is a common dental procedure that saves damaged teeth from having to be extracted. The only alternative to a root canal is having the tooth extracted and replaced with a bridge, implant, or removable partial."
Dr. Martin Kimmel, DDS, a leading Clinical Investigator for new laser applications, and teacher in the Dental Residency program at St. Barnabas Hospital, commented, ``In a study conducted at the Dental Clinic of St. Barnabas Hospital in New York, a new and exciting modality for root canal procedures was investigated. This study clearly demonstrated the Waterlase's ability to remove pulpal tissues as well as tooth structure from the root canal walls. The procedures were performed with specially designed tips that are flexible and narrow, and can easily navigate inside the canal to effectively clean and remove diseased tissue. This represents a major advancement in dental technology that will provide numerous clinical benefits to our patients."
According to Dr. Chen, the Waterlase™ gives dentists the ability to perform an entire root canal with only one tool, the laser, rather than using drills, scalpels and endo-files.
He added, ``Other advantages of laser endodontics include: laser irradiation in the root canal can reduce bacterial pathogens; laser energy can remove debris and smear layer, which consists of organic and tooth substances (inorganic, organic elements such as pulp tissue, debris, odontoplastic processes, micro-organisms and blood cells); the laser energy also removes dentin from the canal wall and can smoothen and resolidify the dentin to close the openings of tubules, resulting in a smooth internal structure and a better apical seal for the obturation material. An additional advantage of the Waterlase™ is the capability of opening calcified canals which currently represents a challenge for other endodontic instruments. The concern of the thermal effect that can cause periodontal damage with other laser wavelengths is resolved due to the advances of the YSGG Hydrokinetic™ technology using water."
Dr. Chen is a renowned laser dentist and lecturer and has performed numerous root canals using the Waterlase™. He is a Master in the Academy of General Dentistry, Fellow American College of Dentists, Fellow of the International College of Dentists and a Master in Academy of Laser Dentistry. < p> For more information on root canal therapy go to www.aae,org.
About BIOLASE
BIOLASE Technology, Inc. ( www.biolase.com ) is a medical technology company that manufactures and markets advanced dental, cosmetic, aesthetic and surgical products, including Waterlase (HydroKinetic®) surgical cutting systems, LaserSmile™, and other advanced laser and non-laser products for the medical market. The company's products incorporate patented and patent-pending technologies in the pursuit of painless surgery. BIOLASE is a leading provider of painless hard and soft tissue dental laser technology.
The matters discussed in this news release include forward-looking statements that are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to, the effect of actions of third parties, including governmental officials, the timely development and acceptance of new products, the impact of competitive products and pricing, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the reports on Forms 10-K and 10-Q. Actual results may differ materially from those projected. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.