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, as reported by the American Academy of Periodontology (AAP).
Calculus removal is a critical procedure in successfully managing and
treating periodontal disease. Cleaning the surface of the tooth's root is
conventionally performed by scraping with a hand instrument or using
ultrasonics. However, clinical studies indicate these methods can remove
healthy tooth structure in the process. BIOLASE's patented 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 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 so that new attachment with the gums 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 now closer to reversing the disease than we have
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 monitor those patients until
they needed surgery. But now, if they start to have breakdowns, we can
perform a breakthrough laser procedure with root surface calculus removal
that actually reverses the breakdown process, so those patients can avoid
more invasive periodontal surgery."
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, it is also an alternative treatment for the
general practitioner who is treating mild to moderate periodontal cases.
Patients are also more likely to accept the treatment when they hear that
it is minimally-invasive. Those who have had the 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, in New York, NY, said, "This
therapy changes the environment in the periodontal pocket through removal
of inflamed tissue and root surface calculus to promote healthy tissue
BIOLASE Chief Executive Officer David M. 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. 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. To address an aging
population, we are very pleased to assist doctors in providing an
efficient, effective, and more comfortable solution for treating
Feedback from patients has also been positive. A recent periodontal
patient, 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, and 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."
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).
SOURCE: BIOLASE Technology, Inc.