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Somnoplasty(R) Procedure Clinical Foundation Grows Significantly -- Five Peer Reviewed Articles Published in March.

SUNNYVALE, Calif., April 12 /PRNewswire/ --

Somnus Medical Technologies, Inc. (Nasdaq: SOMN), announced today that in the month of March, five peer reviewed journal articles were published documenting the safety and effectiveness of the Somnoplasty(R) Procedure in the treatment of sleep disordered breathing, including snoring.

"The extensive clinical foundation of the Somnoplasty(R) System grew significantly with the publication of five peer reviewed studies -- three in one journal, Otolaryngology - Head and Neck Surgery," said John Schulte, President and CEO of Somnus Medical Technologies, Inc. "A key element of our overall strategy to drive the adoption of the Somnoplasty Procedure is to conduct high caliber clinical studies that are able to withstand peer review and ultimately be published. There are now a total of fifteen published articles on the Somnoplasty system, with many additional studies in the pipeline, which will continue to demonstrate the effectiveness of our procedure and expand our market potential," he added.

Initially thought to be nothing more than embarrassing for snorers and irritating to their bed partners, snoring is now recognized as a symptom of sleep-related breathing disorders including obstructive sleep apnea syndrome and upper airway resistance syndrome. These conditions occur when throat muscles relax during sleep, causing tissues in the back of the mouth and throat to collapse and block the airway.

The Somnoplasty(R) System, developed by Somnus Medical Technologies, Inc., is the only treatment available that uses temperature controlled radiofrequency (TCRF) energy to shrink and tighten enlarged tissues that cause upper airway obstruction including the inferior turbinates, soft palate/uvula and base of tongue. Controlled thermal energy is delivered to precise locations within the upper airway using an electrode. This process creates coagulative lesions that are naturally resorbed in approximately three to eight weeks, reducing excess tissue volume and opening the airway.

Published in Otolaryngology -- Head and Neck Surgery, March 2000

The first study, a prospective, nonrandomized clinical trial completed by Coleman and Smith of the Vanderbilt Bill Wilkerson Center for Otolaryngology and Communication Sciences, Department of Otolaryngology, confirmed the Somnoplasty Procedure safe and effective for tissue reduction of the soft palate to treat bothersome snoring and sleep-disordered breathing.

Twelve healthy volunteers with socially disruptive snoring underwent the Somnoplasty Procedure in an approved outpatient treatment facility. Three to four months after RF tissue reduction, a significant reduction in the level of snoring occurred in all twelve patients as rated by the bed partner. Daytime sleepiness index scores also decreased and no significant adverse events or complications were reported.

The second article was a comparative pain study conducted at the Stanford University Sleep Disorders Clinic, Center of Excellence, by Troell, et. al. It found that TCRF energy for treatment of the soft palate produced significantly less post treatment pain than laser-assisted uvulopalatoplasty (LAUP) or uvulopalatopharyngoplasty (UPPP). Narcotic analgesics were used in 100% of patients in the UPPP and LAUP groups for an average of 12 days while only 9% of the TCRF patients used narcotic analgesics for only 3 days.

Also published was an extended follow-up study for patients treated with the Somnoplasty System for habitual snoring, published by Li, et. al. of the Stanford University Sleep Disorders and Research Center. Twelve to eighteen months after treatment, the relapse in snoring was comparable to the more invasive procedures of UPPP and LAUP. However, the minimally invasive nature of TCRF treatment provided high patient acceptance for retreatment and the relapse of snoring was improved with further treatment.

Published in Operative Techniques in Otolaryngology-Head and Neck Surgery,

March 2000

An article by T. L. Smith, MD, MPH and J. M. Smith, PhD, describes the role of temperature-controlled RF energy delivery for tissue volume reduction in the treatment of upper airway obstruction. This article reviews the history, techniques, biophysics and histological effects of RF needle ablation and describes temperature control as a recent advance in electrosurgery technology that optimizes tissue volume reduction.

Published in HNO, March 2000

In a German study conducted by Fischer Y of the Universitats-HNO-Klinik Mainz the Somnoplasty Procedure was used for reduction of the soft palate in the treatment of snoring and obstructive sleep apnea syndrome. Twenty-nine patients with habitual snoring underwent treatment. Eight received TCRF energy exclusively and in the remaining 21 it was combined with other surgery of the upper airway. The study concluded TCRF tissue volume reduction of the soft palate is successful in the treatment of snoring and may be helpful in the treatment of mild obstructive sleep apnea syndrome.

About the Somnoplasty System and Its Applications

Somnus Medical Technologies, Inc. is pioneering a new standard of care for the treatment of upper airway disorders. The company's Somnoplasty System provides physicians with a suite of products that utilize its proprietary temperature-controlled radiofrequency (TCRF) technology to reduce tissue in the upper airway with a minimally invasive procedure. In 1998, the company received 510(k) clearance for the use of the Somnoplasty System in the treatment of obstructive sleep apnea syndrome and upper airway resistance syndrome. The Somnoplasty System is also cleared to treat habitual snoring (soft palate/uvula) and chronic nasal obstruction (enlarged inferior turbinates). Clinical evaluations are underway to further expand the indications for the treatment of other upper airway obstructions.

Forward-Looking Statements

This news release contains forward-looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, the risks and uncertainties associated with the nature and timing of reimbursement, product acceptance and adoption, consumption rates, outcome of clinical trials and the strength of the patent portfolio, as well as those set forth in the company's latest annual report on Form 10-K filed with the Securities and Exchange Commission. Copies of the annual report on Form 10-K are available by calling the company's investor relations contact, Janet Nelson, at 415-296-2274.

Somnus is headquartered in Sunnyvale, Calif., and its stock is traded on the Nasdaq National Market System under the symbol SOMN. The company's Web site addresses are and For information on Somnus via fax at no cost, dial 800/PRO-INFO (+732-544-2850 outside the United States).

Somnus, Somnoplasty and the Somnus Medical Technologies logo are registered trademarks or service marks of Somnus Medical Technologies, Inc. Patents pending.
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Publication:PR Newswire
Geographic Code:1USA
Date:Apr 12, 2000
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