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| |  Company Founded to Develop Treatments for Snoring, Obstructive Sleep Apnea SUNNYVALE, Calif. -- April 29, 1997-- Somnus Medical Technologies, Inc. is developing unique, cost-effective treatments for upper airway disorders such as habitual snoring and obstructive sleep apnea (OSA), a disorder characterized by interrupted breathing during sleep. Somnus was founded by Stuart Edwards and David Douglass to develop, manufacture and market the least-invasive, most efficacious and most cost-effective devices to treat a range of obstructions that can block a patient's upper airway (passages in the back of the mouth, the nose and the throat). "Although the upper airway is the body's lifeline for its most vital needs, medical technology has mostly neglected this very complex and fragile anatomy," said Stuart Edwards, president, chief executive officer and chairman of Somnus. "Now, Somnus is combining extensive experience in radio-frequency technology and minimally invasive medical systems to bring to market advanced solutions for disorders such as snoring and sleep apnea." "Here in the United States and internationally, there is tremendous demand from both patients and payors for non-surgical, outpatient procedures which have the potential to minimize the pain, recovery time and cost of treating upper airway obstructions. Somnus intends to meet this demand." The company's first product line is the Somnoplasty(TM) system, a minimally invasive radio-frequency (RF)-based set of devices. Somnoplasty is currently undergoing clinical evaluation in the United States and Europe to expand current claims to include the reduction or elimination of habitual snoring and other upper airway obstructions. Habitual snoring is a form of upper airway obstruction which affects 40 million people in the United States. It is often associated with OSA, a sometimes debilitating condition suffered by approximately 20 million Americans. Epidemiological evidence suggests an association between OSA, hypertension and cardiovascular disease, and according to the National Commission on Sleep Disorders Research, OSA results in approximately 38,000 cardiovascular deaths annually in the United States. "Upper airway obstructions can destroy the restorative qualities of sleep and often severely affect the health of a vast number of people in the United States and around the world," said William Dement, M.D., Ph.D., co-director of the Stanford Sleep Research Center and professor of psychiatry and behavioral sciences at Stanford University. "There is a pressing need in the medical community and healthcare industry to develop new, minimally invasive therapies for these serious health conditions. Technological innovations can bring more tolerable and less painful treatments to millions of sufferers and help them breathe, sleep and live more healthily." Somnus recently concluded an agreement with Medtronic Inc. under which Medtronic made a minority equity investment in Somnus and gained exclusive distribution rights to the Somnoplasty system in Europe and certain Pacific Rim countries. Somnoplasty: A Simple, Minimally Invasive Therapy Somnoplasty is intended to treat upper airway obstructions by shrinking the excess tissue that causes the obstruction. Somnoplasty is designed to minimize the risk of bleeding and pain, and to shorten the patient's recovery period, by preserving the mucosa, or surface layers of tissue. Somnoplasty is intended to be performed under local anesthesia in an outpatient setting. The entire procedure, including patient preparation and administration of local anesthesia, is intended to take less than 30 minutes, with typically less than five minutes necessary for the RF ablation itself. During the somnoplasty procedure, local anesthesia is administered, after which a tiny electrode is positioned under the mucosa of the target area. The physician does not cut or slice away excess tissue. Instead, the electrode transmits very low levels of RF energy to create molecular friction within the tissue, generating heat that destroys tissue in a confined area. In animal studies of Somnoplasty, the ablated tissue was resorbed after a few weeks, resulting in a reduction in the size of the structure treated. Somnoplasty is currently undergoing clinical trials for the treatment of snoring and other upper airway obstructions at the following U.S. medical institutions: Stanford University Medical Center (Stanford, Calif.); the University of Maryland Medical Center (Baltimore, Md.); Columbia University-Presbyterian Medical Center (New York, N.Y.); Albany Medical Center (Albany, N.Y.); Candler Hospital (Savannah, Ga.); and Vanderbilt University Medical Center (Nashville, Tenn.). Clinical evaluation is also under way in Europe and Somnus plans to initiate clinical trials in Australia and Japan in 1997. "Somnus Medical Technologies has committed to a systematic, scientific approach in the investigation and development of its new radio-frequency technology," said Nelson Powell, M.D., chairman of Somnus' Scientific Advisory Board, assistant clinical professor at Stanford University and co-director of the Stanford Sleep Disorders Program. "This commitment is viewed by the Scientific Advisory Board as a major step forward in fulfilling the social responsibility of delivering new treatment options for patients with upper airway obstructions."
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