Healthcare Industry News: obstructive sleep apnea
News Release - September 6, 2006
Health Canada Approves Restore Medical's Pillar(R) Palatal Implant SystemMinimally Invasive Procedure Offering Safe, Effective Treatment for Snoring and obstructive sleep apnea Now Available to Help Canadians Sleep Soundly and Feel Better
ST. PAUL, Minn.--(HSMN NewsFeed)--Sept. 6, 2006--Restore Medical (Nasdaq:REST ) today announced that Health Canada has approved sale of the Company's Pillar® Palatal Implant System, providing Canadians access to the only FDA-cleared palatal implant to treat snoring and mild-to-moderate obstructive sleep apnea (OSA). The Pillar System is being distributed in Canada through a partnership with Southmedic of Ontario. For the millions of Canadians who are frustrated with traditional treatment options or risky, painful surgery, the Pillar Procedure offers a safe and effective in-office treatment with minimal pain and fast recovery.
It is estimated that more than 10 million Canadians snore, and more than two million suffer from OSA, a serious health disorder that causes people to stop breathing up to hundreds of times each night, and is linked to heart disease, high blood pressure and stroke. Unlike traditional surgical treatments, the Pillar Procedure is performed in a single office visit using local anesthetic, allowing patients to resume normal diet and activities the same day.
During the Pillar Procedure, a physician places three small polyester implants in the soft palate located at the back of the roof of the patient's mouth. Airflow in the back of the mouth can cause loose palatal tissue to flutter or vibrate causing snoring, or can collapse and obstruct the upper airway causing OSA. The Pillar implants are designed to add structural support and stiffen the soft palate tissue, thereby reducing or eliminating this tissue flutter, vibration or collapse.
"We are very excited about our distribution partnership with Southmedic as we bring the Pillar Procedure to Canada and provide people who suffer from snoring and OSA a proven, minimally invasive, safe and effective treatment alternative," said Bob Paulson, President and CEO of Restore Medical. "We are proud to offer the Pillar Procedure in more than 24 countries worldwide, and with this approval from Health Canada, we've taken another step toward making the Pillar Procedure available to people suffering from snoring and obstructive sleep apnea worldwide, allowing them to sleep better and feel better."
"We're dedicated to providing hospitals and physicians throughout Canada with the world's leading medical products," said Lee McDonald, President of Southmedic. "The Pillar Procedure enables physicians to offer a simple, in-office procedure that is clinically proven to be safe and effective. We're looking forward to working with Restore Medical to bring physicians and patients a great, minimally invasive treatment for obstructive sleep apnea and snoring."
Restore Medical will be showcasing the Pillar Procedure at the upcoming American Academy of Otolaryngology -- Head and Neck Surgery (AAO-HNS) conference being held September 17-20, in Toronto, where numerous clinical studies will be presented that highlight the Pillar Procedure's safety and long-term efficacy. Following the conference, Restore Medical and Southmedic will be offering training sessions for physicians across Canada.
About Restore Medical and the Pillar Procedure
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.
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, 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 are discussed in documents filed by Restore Medical with the Securities and Exchange Commission from time to time, including its registration statement on Form S-1 filed on May 12, 2006 (Reg. No. 333-132368), and its Form 10-Q for the quarter ended June 30, 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.
Source: Restore Medical
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