17.09.2007 13:01:00

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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