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| |  Somnoplasty Treatment Provides Significant Relief Of Nasal Obstruction SUNNYVALE, CA -- December 2, 1999 -- The long-term effectiveness of treating chronic nasal obstruction with temperature-controlled radiofrequency (RF) energy is detailed in a study conducted by Dr Timothy L. Smith, and published in the November issue of The Laryngoscope. Patients reported a significant decrease in the degree and frequency of nasal obstruction that was sustained for one year following treatment. RF energy was delivered using the Somnoplasty(TM) System developed by Somnus Medical Technologies, Inc.
"Radiofrequency Tissue Ablation of the Inferior Turbinates Using a Thermocouple Feedback Electrode," was conducted by Dr. Smith and colleagues Dr. Alex J. Correa, Tim Kuo, and Dr. Lou Reinisch. The paper reports on the Somnoplasty(R) Procedure for turbinates to relieve chronic nasal obstruction, a condition affecting some 50 million Americans whom are forced to breathe through their mouths due to a constantly stuffy nose. "The Somnoplasty System's clinical foundation continues to grow with the publication of this peer-reviewed article. It is our third published paper on chronic nasal obstruction and our ninth published paper across all of our indications," said John Schulte, Somnus President and CEO. "This is the first study which demonstrates the long-term benefits of treating chronic nasal obstruction with the Somnoplasty Procedure." According to several large population surveys, approximately 20 percent of Americans suffer from a condition called "chronic rhinitis" and one of its common symptoms is nasal congestion. Chronic nasal congestion can impair normal breathing, force patients to breathe through the mouth and turn the simple acts of eating, drinking, speaking and sleeping into annoying and sometimes uncomfortable experiences. It also can also contribute to symptoms such as sleeplessness, fatigue and headaches. Nasal obstruction is typically caused by enlargement of the inferior nasal turbinates-small, shelf-like structures within the nose. Normally, turbinates swell and contract to warm and humidify air as it is inhaled. Chronic turbinate enlargement blocks the air passage and is irreversible except with surgical or medical intervention. The study was conducted at Vanderbilt University and evaluated 11 patients who had previously failed medical therapy for nasal obstruction. Each patient received a single turbinate treatment on each side of the nose. All 11 patients reported significant improvements four to eight weeks following treatment in the degree and frequency of nasal obstruction. The improvement occurred between 18-21 days post treatment and was sustained for one year in 10 patients (one patient was lost to follow-up). The Somnoplasty Procedure delivers temperature controlled radiofrequency energy which "allows the surgeon to protect nearby tissues and mucosa and potentially decrease morbidity such as crusting, pain and bleeding." The actual treatment only takes about 15 minutes and is done under local anesthesia on an outpatient basis. Only one patient required pain medication (acetaminophen) after the procedure and no post operative bleeding was reported. The investigators describe the Somnoplasty Procedure's potential advantage is a "minimally invasive technique using relatively low power and tissue temperature which could lead to reduced patient pain decreased frequency and severity of complications, avoidance of general anesthesia and cost savings. " Dr. Smith is an associate professor of Otolaryngology at the Medical College of Wisconsin and a staff physician at Froedtert Hospital, a major affiliate of the school. Dr. Smith plans to launch another, larger clinical trial at Froedtert Hospital to compare the outcomes of the Somnoplasty Procedure to long-term medication for relief of chronic nasal obstruction. Somnus' proprietary Somnoplasty System uses RF energy to provide a minimally invasive and less painful treatment of upper airway obstructions under local anesthesia. The system generates heat at temperatures between 60 degrees C (140 degrees F) and 95 degrees C (203 degrees F) for creating finely controlled lesions at precise locations within the upper airway. As the tissue heals in approximately three to eight weeks, it reduces tissue volume, opening the airway. A typical Somnoplasty Procedure is performed on an outpatient basis, takes 30 to 45 minutes, with only five to ten minutes required for RF energy delivery. One or more treatments may be required to achieve optimal results depending on the treatment site.
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