New U.S. Multi-Center Clinical Study Affirms Efficacy and Benefit of Restore Medical's Pillar(R) Procedure.Results of Double-blind, Placebo-controlled OSA 1. OSA - Open Scripting Architecture.
2. OSA - Open System Architecture. Clinical Study Reported at the 111(th) AAO-HNS AAO-HNS American Academy of Otolaryngology - Head and Neck Surgery (Alexandria, VA) Annual Meeting
ST. PAUL, Minn. -- Restore Medical, Inc. (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :REST), developer of the innovative Pillar([R]) Palatal pal·a·tal
palatal (pal´t Implant System - a simple, minimally-invasive treatment to help individuals suffering from snoring snoring, rough, vibratory sounds made in breathing during sleep or coma. The noisy breathing is the result of an open mouth and a relaxation of the palate; it is frequently induced by lying on one's back. and mild-to-moderate obstructive sleep apnea Obstructive sleep apnea (OSA)
A potentially life-threatening condition characterized by episodes of breathing cessation during sleep alternating with snoring or disordered breathing. (OSA) - today announced the presentation of positive results from the first U.S. multi-center Level 1 evidence based medicine clinical study of its Pillar palatal implants, which affirmed the efficacy observed in earlier studies in the treatment of mild to moderate OSA. David Steward, M.D., Associate Professor and Director of Clinical Studies, University of Cincinnati The University of Cincinnati is a coeducational public research university in Cincinnati, Ohio. Ranked as one of America’s top 25 public research universities and in the top 50 of all American research universities, Medical Center, and his colleagues, presented their findings, "Palate Implants for OSA: Multi-Institution, Randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. , Placebo Controlled Study," yesterday at the 111th Annual Meeting & OTO EXPO of the American Academy of Otolaryngology - Head and Neck Surgery Foundation in Washington D.C.
One hundred adults with mild to moderate OSA were enrolled in this clinical study and randomized into two groups. Patients in the treatment group underwent a procedure in which they received three Pillar palatal implants, and patients in the control group underwent an identical procedure, but did not receive Pillar palatal implants. The investigators evaluated and compared objective and subjective outcomes of patients in both groups, and reported statistically significant differences in the primary and several secondary outcome measures favoring the group receiving Pillar palatal implants as compared to the placebo control group.
Bob Paulson, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Restore Medical, stated, "The reported outcomes from this U.S. multi-center Level 1 clinical study are consistent with the U.S. single center Level 1 placebo-controlled clinical data reported by Dr. Michael Friedman at the 2006 AAO AAO American Association of Orthodontists; American Academy of Ophthalmology; American Academy of Otolaryngology; American Academy of Osteopathy.
AAO annual meeting. Pillar palatal implants add structural support to and stiffen the soft palate soft palate
The movable fold, consisting of muscular fibers enclosed in mucous membrane, that is suspended from the rear of the hard palate and closes off the nasal cavity from the oral cavity during swallowing or sucking. , eliminating or minimizing the soft palate flutter or collapse that can cause or contribute to chronic snoring and OSA. While people with OSA generally suffer from obstruction of more than one level of the upper airway up·per airway
The portion of the respiratory tract that extends from the nostrils or mouth through the larynx. , the soft palate is a contributing factor in approximately 80 percent of cases, and Pillar palatal implants can effectively treat the soft palate alone, or as part of a combination procedure to treat multi-level upper airway obstruction. The findings from these clinical studies demonstrate that the Pillar Procedure is a simple, office-based procedure with minimal pain or complications, which can effectively treat the soft palate component of mild to moderate OSA and significantly improve patients' quality of life."
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 European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the
European Community . 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.
Except for historical information, this press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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.