Long-Term Study of the Pillar(R) Procedure Shows Reduction of Sleep Apnea in 81 Percent of Patients and Offers New Hope to Frustrated CPAP Users.

ST. PAUL, Minn. -- Data Presented at 109th American Academy of Otolaryngology--Head and Neck Surgery Annual Meeting (AAO-HNS)

Only FDA-cleared Palatal Implant for Obstructive Sleep Apnea Proves Safe and Effective Alternative for Frustrated CPAP Users and Those Considering Invasive Surgery; Helps Improve Health and Relationships

For the millions of sleep apnea sufferers worldwide looking for an effective, one-time, minimally invasive treatment with long-term benefits, help is here. The results of a one-year clinical study of Restore Medical's Pillar palatal implants, the only FDA-cleared implantable device treatment for obstructive sleep apnea (OSA), demonstrate that the Pillar Procedure is a safe and effective first-line treatment for mild-to-moderate OSA, with more than 80 percent of study participants demonstrating a reduction of their apnea. OSA is a serious medical condition that causes people to stop breathing up to hundreds of times a night during sleep and the effects have been linked to heart disease, high blood pressure, stroke and impotency.

The study results, presented at the 109th American Academy of Otololaryngology--Head and Neck Surgery (AAO-HNS) Annual Meeting, September 25-28, 2005, give new hope to sleep apnea sufferers and their bed partners who have been unable to comply with and are searching for an alternative to the most common therapy for OSA - Continuous Positive Airway Pressure (CPAP). CPAP is a life-long therapy that delivers pressured air through a mask that must be worn all night, every night. Multiple published research studies have shown that patient compliance with CPAP therapy can be as low as 50 percent, due to the general discomfort, inconvenience, and claustrophobia that often results from wearing the mask every night. OSA sufferers who do not use their CPAP machine often disturb their bed partners with socially disruptive snoring sounds that frequently force the bed partners to sleep in separate rooms, causing additional strain and discord in relationships.

"Though CPAP seemed to help me, I was frustrated with it and couldn't comply with the regimen of using it. My daughter was afraid of me when I wore my CPAP mask, and it didn't help much with my relationship with my wife either," said sleep apnea sufferer Paul Younan of Chicago. "When my doctor told me about the surgical options, it sounded like he wanted to carve me up like a pumpkin. I decided on the Pillar Procedure, which was so simple and pain-free that I was eating pizza that night. I'm now cured of my sleep apnea and sleeping soundly - and so is my wife."

Pillar Procedure: An Effective, Safe and Less Painful Procedure than Major Surgeries

Historically, the only options for OSA patients who were not able to tolerate or comply with CPAP were aggressive and invasive surgical approaches that removed tissue. These surgeries also involve painful recoveries which often last up to two-to-four weeks before normal activities can be resumed.

The Pillar Procedure, which was cleared by the FDA for the treatment of OSA in August 2004, is a minimally invasive, first-line treatment option for patients suffering from mild-to-moderate OSA and snoring. OSA, the most common form of sleep apnea, is caused by a blockage of the airway, often when the soft tissue in the back of the throat (the palate) collapses and closes during sleep and obstructs the airway. People with untreated sleep apnea stop breathing repeatedly during sleep and may wake up 20 to 30 times or more per hour throughout the night. The Pillar Procedure involves the placement of three tiny woven implants, which are inserted into the patient's soft palate, causing the palate to stiffen. The stiffened palate helps to reduce or prevent blockages of the airway - effectively treating sleep apnea and substantially reducing the severity of snoring in most individuals.

The Pillar Procedure offers a clinically effective, safe and less painful alternative to traditional surgical approaches that involve the irreversible removal of tissue (uvulopalatopharyngoplasty, laser-assisted uvulopalatoplasty), or the scarring and burning of tissue (radiofrequency ablation), which often require multiple treatments. These more invasive surgical treatments have historically shown variable success rates, in addition to the heightened risks associated with the general anesthesia required to perform these procedures, and the increased post-operative pain, and side effects.

"The results from our long-term clinical study of the Pillar Procedure further validate our innovative approach to treating sleep-disordered breathing with a clinically effective, low cost, minimally invasive treatment with limited discomfort and recovery time for the patient," said Bob Paulson, CEO of Restore Medical. "With more than 1,000 physicians worldwide treating patients, the Pillar Procedure has already enhanced the lives of more than 10,000 patients. We look forward to building upon the clinical success of the Pillar Procedure as we help improve the health and lifestyle of patients around the globe who suffer from sleep apnea and snoring."

Long-term Efficacy, Low Cost, and Simplicity: Key Findings in Recent Study

The study, "Long-Term Follow-up of Palatal Implants for Treatment of Obstructive Sleep Apnea," conducted and authored by Stale Nordgard, MD; Gerhard Hein, MD; Brit Kari Stein, MD; Ketil Skjostad, MD; and Joachim T. Maurer, MD was presented at the 109th American Academy of Otololaryngology-Head and Neck Surgery (AAO-HNS) Annual Meeting & OTO EXPO in Los Angeles, September 25-28, 2005.

Clinical highlights of the study include:

--81 percent of the patients achieved reductions and nearly 60 percent achieved resolution of their apnea as measured by their Apnea Hypopnea Index (a measure of the average number of times a patient wakes up during each hour of sleep) to less than 10/hr;

--Results were better than or comparable to the results reported in studies of Uvulopalatopharyngoplasty (UPPP) (a surgical procedure that removes excess tissue at the back of the throat) and were achieved in a low-cost, single-procedure, outpatient office setting, with significantly less pain and morbidity than that experienced with UPPP procedures;

--The clinical effectiveness of the Pillar Procedure suggests that the Pillar treatment therapy could be considered as the first-line option for patients diagnosed with mild-to- moderate sleep apnea.

"This study demonstrated both short and long-term efficacy of the Pillar Procedure for the treatment of mild-to-moderate OSA," said Dr. Nordgard. "We also were able to prove the advantages of the procedure as a single-stage, low-cost, in-office, completely reversible treatment with minimal patient discomfort. Based on these findings, the Pillar Procedure could be considered a first-line OSA treatment and ideal for non-compliant CPAP patients."

"We're encouraged by the work being done to research alternative treatment options for the millions of sleep apnea sufferers who we support each year," said Rochelle Goldberg, MD, president of the American Sleep Apnea Association. "This most recent study of the Pillar Procedure is promising for patients seeking long-term relief from this serious medical condition."

To learn more about Restore Medical and the Pillar Procedure, or to find an ear, nose and throat (ENT) physician in your area, visit www.pillarprocedure.com.

To learn more about sleep apnea, visit the Web site of the American Sleep Apnea Association, www.sleepapnea.org.

About Restore Medical

Restore Medical is a privately-held company that develops, manufactures, and markets innovative medical devices to treat sleep disordered breathing. The Company's proprietary, patented Pillar(R) palatal implant system is cleared by the FDA for the treatment of snoring and mild-to-moderate obstructive sleep apnea. The Company's Pillar devices are implanted in a minimally invasive office procedure and are designed to provide patients suffering from these sleep breathing disorders with an effective, long-term treatment. The Pillar palatal implant system is available throughout the U.S. and multiple countries in Asia Pacific, Europe, and the Middle East. For more information about the Pillar procedure and physicians who offer the therapy, visit the Company's Web site at www.pillarprocedure.com.

PLEASE NOTE: VNR and B-roll footage of this story can be found as follows:

FEED DATE: WEDNESDAY, NOVEMBER 30, 2005

FEED TIME: 1:30 - 1:45 PM ET (FED IN ROTATION)

COORDINATES: C-BAND: IA 5 (C) /TRANSPONDER 24

DL FREQ: 4180 HORIZONTAL

RE-FEED DATE: MONDAY, DECEMBER 5, 2005

RE-FEED TIME: 1:30 - 1:45 PM ET (FED IN ROTATION)

COORDINATES: C-BAND: IA 5 (C) /TRANSPONDER 24

DL FREQ: 4180 HORIZONTAL