17.09.2007 13:01:00
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Restore Medical Begins Clinical Study to Evaluate Pillar Palatal Implants in Combination with Continuous Positive Airway Pressure
Restore Medical, Inc. (NASDAQ:REST), developer of the innovative
Pillar® Palatal
Implant System – a simple, minimally-invasive
treatment to help individuals suffering from snoring and
mild-to-moderate obstructive sleep apnea (OSA) –
today announced enrollment of the first patients in a clinical study
evaluating the use of Pillar palatal implants in combination with
continuous positive airway pressure (CPAP) therapy in the treatment of
mild to moderate OSA. Many patients have difficulty complying with CPAP
therapy if high levels of airway pressure are necessary for their
therapy to be successful. This clinical study will evaluate a combined
therapeutic approach of stiffening the soft palate with Pillar palatal
implants, thereby allowing the reduction of CPAP pressures and
potentially improving patient compliance with CPAP therapy.
This clinical study is expected to enroll up to 100 patients, and is one
of the first multi-disciplinary clinical studies involving active
collaborations between sleep medicine physicians and otolaryngologists
to evaluate the use of a minimally-invasive procedure to treat the
palatal component of OSA in combination with CPAP. This clinical study
has been structured as a Level 1 evidence-based medicine, prospective,
randomized, placebo-controlled study and is being conducted at eight
sleep centers across the U.S. This study is expected to be completed by
mid-2008 and the clinical results, if favorable, will be included in an
application to the FDA to expand the approved clinical indications for
Pillar palatal implants to include use with CPAP.
David M. Rapaport, M.D., Director of the Sleep Center at NYU Medical
Center in New York, and Teofilo Lee-Chiong, M.D., Director of the Sleep
Center at National Jewish Medical and Research Center in Denver, two
leading pulmonologists who specialize in sleep medicine and are serving
as co-principal clinical investigators in this Pillar/CPAP combination
therapy study, jointly said, "We are pleased
to be leading this innovative, multi-center, multi-disciplinary study to
assess the effectiveness of a combination approach to improve compliance
with CPAP therapy. This combination therapy approach could give
physicians another treatment option to help large numbers of people
suffering from OSA to improve their quality of life.”
In 2004 the Journal of the American Medical Association (JAMA)
reported that OSA affects an estimated 59 million people in the U.S.,
and that the vast majority of people with OSA remain undiagnosed. The
universally regarded first-line therapy for OSA is CPAP. While
CPAP therapy is very effective when used properly, the reported patient
non-compliance rates for CPAP are estimated to be up to 50 percent or
more due to a number of lifestyle factors, including physical discomfort
that oftentimes results from high CPAP pressures.
"We are very excited to begin enrolling
patients in this first-of-its-kind clinical study,”
said Bob Paulson, President and CEO of Restore Medical. "CPAP
is first-line treatment for patients suffering from OSA, and many people
have difficulty complying with their CPAP therapy due to high pressures.
A number of physicians across the country have independently reported
that by using Pillar palatal implants in combination with CPAP therapy,
they have been able to reduce CPAP pressure levels and improve patient
CPAP compliance. We strongly endorse this collaborative approach between
sleep medicine and ENT physicians and believe Pillar palatal implants
can play in important role in combination therapies to treat OSA and
improve patients’ quality of life.” About CPAP Therapy and the Pillar Procedure
Continuous positive airway pressure therapy helps people who have OSA
breathe more easily during sleep. A CPAP machine delivers a stream of
compressed air through a nasal or face mask, which keeps the upper
airway open by reducing and/or preventing airway tissue collapse, and
allowing unobstructed breathing during sleep. During the Pillar
Procedure three tiny polyester implants are placed into the soft palate
in a simple, 20-minute in-office procedure using only local anesthetic.
The Pillar palatal implants add structural support to and stiffen the
soft palate, eliminating or minimizing the soft palate flutter or
collapse that can cause or contribute to chronic snoring and obstructive
sleep apnea.
About Restore Medical
Restore Medical develops, manufactures and markets innovative medical
devices to treat sleep-disordered breathing. The Company’s
proprietary Pillar Palatal Implant System is the only implantable
palatal device to treat snoring and mild-to-moderate obstructive sleep
apnea to be approved by the U.S. Food and Drug Administration and Health
Canada, and to have received the CE Mark for sale in the European Union.
The Pillar Palatal Implant System is sold throughout the U.S. and
Canada, and in various countries in Asia Pacific, Europe, South America
and the Middle East.
For more information about Restore Medical, the Pillar Procedure and
physicians who offer the Pillar Procedure, visit the Company’s
website at www.restoremedical.com
or www.pillarprocedure.com.
Forward-Looking Statements
Except for historical information, this press release contains "forward-looking
statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements included in
this press release that address activities, events or developments that
Restore Medical expects, believes or anticipates will or may occur in
the future, including, particularly, statements about actual or
anticipated outcomes of clinical studies, are forward-looking
statements. All forward-looking statements are based on assumptions made
by Restore Medical’s management based on its
experience and perception of historical trends, current conditions,
expected future developments and other factors it believes are
appropriate in the circumstances. Such statements are subject to a
number of assumptions, risks and uncertainties, many of which are beyond
the Company’s control, and which could cause
actual results or events to differ materially from those expressed in
such forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to, market demand and
acceptance of the Company’s products,
competitive factors, pricing and third-party reimbursement for the
Company’s products, expansion and rate of
success of the Company’s sales force,
completion and results of clinical studies, ongoing regulatory
compliance, success of new product development, general economic
conditions and seasonal trends, and other risks and factors that are
discussed in documents filed by Restore Medical with the Securities and
Exchange Commission from time to time, including its Annual Report on
Form 10-K for the year ended December 31, 2006. Forward-looking
statements represent the judgment of the Company’s
management as of the date of this release, and Restore Medical disclaims
any intent or obligation to update any forward-looking statements.
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