Healthcare Industry News:  obstructive sleep apnea 

Devices

 News Release - October 5, 2006

Six New Studies Document Efficacy and Sustained Benefit of Restore Medical's Pillar(R) Procedure

Results of Double-Blind Placebo-Controlled, Long-Term and Combination Therapy Studies Reported at the 110th AAO-HNS Annual Meeting

ST. PAUL, Minn.--(HSMN NewsFeed)--Restore Medical (NASDAQ:REST ), developer of the innovative Pillar® Palatal Implant System - a simple, minimally-invasive treatment for individuals suffering from snoring and mild-to-moderate obstructive sleep apnea (OSA) - today announced results of six clinical studies involving the Pillar Procedure that were presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS), held September 18-20. The results of these studies demonstrate the effectiveness of the Pillar Procedure in treating snoring and mild-to-moderate OSA, and add to the body of clinical evidence previously reported in 14 clinical studies that have been published or accepted for publication in peer-reviewed medical journals.

Bob Paulson, CEO of Restore Medical, stated, "Restore Medical and the Pillar Procedure received significant visibility at the 2006 AAO-HNS meeting, which is our most important and prestigious medical conference of the year. Data from six clinical studies, which further establish the safety and efficacy of the Pillar Procedure, were presented by several of the foremost otolaryngologists from the U.S., Europe and Asia."

Commenting on the presentations, Paulson added, "The first two double-blind placebo-controlled studies of the Pillar Procedure to treat mild-to-moderate OSA caused by the soft palate were presented. This data clearly confirmed that the Pillar Procedure can significantly reduce patients' levels of sleep apnea, daytime sleepiness and snoring intensity, which translates to a significant improvement in their quality of life."

Paulson continued, "In addition to these compelling placebo-controlled studies, clinical data from a one-year follow-up OSA study and from a three-year follow-up snoring study were presented, which corroborated data presented at prior AAO-HNS meetings on the long-term safety and efficacy of the Pillar Procedure. Results from another randomized clinical study showed that the Pillar Procedure can be safely and effectively performed in combination with other procedures to improve clinical outcomes in the treatment of mild-to-moderate OSA."

"Future publication of the data from these various Pillar clinical studies in peer-reviewed medical journals will add to the increasing body of clinical evidence that clearly demonstrates the Pillar Procedure is safe, effective and can help people worldwide who suffer from snoring and mild-to-moderate OSA to enhance their quality of life through better sleep," stated Paulson.

The following Pillar clinical studies were presented at the AAO-HNS:

Palatal Implants for the Treatment of obstructive sleep apnea/Hypopnea Syndrome and Snoring: A Double-Blind, Placebo-Controlled Study - Michael Friedman, MD; Paul Schalch, MD; Kedar Kakodkar, MS; Ninos J. Joseph, BS; and Narges Mazloom, BS. This groundbreaking double-blind clinical study was conducted with neither the patient nor the doctor knowing if a placebo ("sham") procedure was performed, or if Pillar implants were placed. Because surgeries typically cannot be researched in this fashion, this study is one of the first to provide level one - or "pure" evidence - of the efficacy of a surgical procedure. The data from this study of 55 patients demonstrated that the Pillar Procedure significantly reduced the level of obstructive sleep apnea (the "Apnea Hypopnea Index," or "AHI"), and improved quality of life, snoring intensity (the "Visual Analog Scale," or "VAS") and daytime sleepiness (the "Epworth Sleepiness Scale," or "ESS"):
  • 38% of patients treated with Pillar implants vs. 0% of control patients experienced an AHI reduction greater than or equal to 50% to an AHI less than or equal to 20 (the criteria traditionally used to demonstrate a "surgical success")
  • 62% of Pillar treated patients vs. 0% of control patients experienced improvements in ESS and VAS
Palatal Implants for OSA: A Placebo-Controlled Study - Joachim Maurer, MD; Gerhard Hein, MD; Karl Hoermann, MD; and Boris Stuck, MD. Dr. Maurer reported on the results of the first 10 patients in this double-blind placebo-controlled clinical study in which patients who received the Pillar Procedure experienced a clinically and statistically significant reduction in the level of their OSA of more than 50%, while patients in the control arm experienced an increase in the level of their OSA.

One-Year Follow-up of Palatal Implants for OSA Treatment - Regina P. Walker, MD; and Howard L. Levine, MD. Drs. Walker and Levine reported that patients who responded favorably to the Pillar Procedure at 90-days post-implant maintained these favorable responses over an extended follow-up period for an average of 15 months post-implant:
  • 77% of patients maintained a reduction in AHI
  • 82% of patients maintained an AHI reduction less than or equal to 20
  • 71% of patients maintained an AHI reduction less than or equal to 10
  • ESS and VAS decreased by 43% and 56%, respectively
Palatal Implants Plus Nasal Surgery for the Treatment of OSA - Peter Catalano, MD; Joel Cohen, MD; and John Romanow, MD. Dr. Catalano reported in this randomized study that patients who underwent a nasal airway procedure in combination with a Pillar Procedure (the "treatment group") had a clinically and statistically significant greater reduction in the level of their OSA compared with those patients who underwent a nasal airway procedure alone (the "control group"):
  • Patients in the treatment group had a mean AHI reduction of 24% vs. 0.5% for patients in the control group
  • 36% of patients in the treatment group had an AHI reduction of greater than or equal to 50% and an AHI less than 20
Three-Year Follow-up of Snorers with Palatal Implants - Stale Nordgard, MD; and Ketil W. Skjostad, MD. This clinical study confirmed that 70% of the bed partners continued to be satisfied with the improvement in the snoring of their partners three years after the Pillar Procedure was performed:
  • Snoring intensity decreased 42%
  • Bed partner satisfaction of 70% at three-years post-procedure was essentially equivalent to the 71% bed partner satisfaction previously reported at one year post-procedure
Additional Palatal Implants for Refractory Snoring - Peter J. Catalano, MD; and John H. Romanow, MD. Dr. Catalano presented data from this physician-sponsored pilot study of 31 patients who were not satisfied with the results of an initial Pillar Procedure in which they received three implants each, in accordance with the FDA-cleared indications. Results from this study showed that patients who received an additional fourth or fifth Pillar implant(s) achieved a clinically and statistically significant decrease in ESS and VAS:
  • ESS decreased after additional implants from 7.4 to 4.6
  • VAS rated for 31 patients following fourth implant decreased from 6.4 to 4.6
  • VAS rated for 10 patients following fifth implant decreased from 6.4 to 4.1
Restore has received an Investigational Device Exemption (IDE) from the Food & Drug Administration to further study the use of a fourth and/or fifth Pillar implant to reduce snoring intensity in patients who did not achieve sufficient relief following the currently indicated three Pillar implants. The Company expects enrollment in this study to begin in the fourth quarter of 2006.

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.

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 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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