BIOLASE Receives First Ever FDA Clearance
for Complete Laser Root Canal Therapy
14 Million Root Canal Procedures Performed Annually in
the USA
SAN CLEMENTE, Calif., Jan. 24 /PRNewswire-FirstCall/ -- 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(TM) 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(TM) 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(TM).''
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(TM) 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(TM) 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(TM) technology using water.''
Dr. Chen is a renowned laser dentist and lecturer and has performed numerous root canals using the Waterlase(TM). 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.
In another arena, Gerhard Will, DDS, published and renowned worldwide and Chief Editor
of the Laser Journal - Germany, commented on the impact of the
Waterlase, "For ten years of watching lasers in dentistry, we have waited for an effective hard and soft tissue laser. The wait is over, the
Waterlase is an important milestone for dentistry. Congratulations to
BIOLASE!"
The matters discussed in this news release include forward-looking statements which 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.
Lasers in the National Spotlight
Laser use in periodontal surgery (bone modification).