VIASYS Healthcare's Respiratory Technologies Division Announces FDA clearance for ORION CPAP for the Therapeutic Treatment of Obstructive Sleep Apnea.Business Editors & Health/Medical Writers CONSHOHOCKEN, Pa.--(BW HealthWire)--May 28, 2002 VIASYS Healthcare Inc.'s (NYSE NYSE See: New York Stock Exchange :VAS) Respiratory Technologies Division today announced that it received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 510(k) clearance to market the ORION CPAP CPAP abbr. continuous positive airway pressure Continuous positive airway pressure (CPAP) A ventilation device that blows a gentle stream of air into the nose during sleep to keep the airway open. . The ORION CPAP will be marketed worldwide by VIASYS for the treatment of patients diagnosed with obstructive sleep apnea Obstructive sleep apnea (OSA) A potentially life-threatening condition characterized by episodes of breathing cessation during sleep alternating with snoring or disordered breathing. (OSA 1. OSA - Open Scripting Architecture. 2. OSA - Open System Architecture. ). According to published statistics OSA affects approximately 12 million individuals in the United States alone with more than 10 million of those undiagnosed. The sleep apnea treatment market is growing at a rate of 20% per year. VIASYS Healthcare has the #1 global market share in the fields of respiratory and neuro diagnostics and a leading share of the market in sleep diagnostics. Randy Thurman, chairman & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of VIASYS Healthcare said: "With the approval of the ORION CPAP and our existing global presence in the respiratory and neuro diagnostics marketplace, VIASYS is well positioned to be a significant competitor in the treatment of obstructive sleep apnea. "It is our goal to be able to offer comprehensive diagnostic and therapeutic support for this disorder to care providers and patients." VIASYS Healthcare is a global, research-based medical technology company focused in respiratory technology, neuro-care and medical/surgical products. VIASYS' products are marketed under well-recognized brand names such as SensorMedics, Bird, Bear, Nicolet, and Jaeger. VIASYS has headquarters in Conshohocken. More information can be found at www.viasyshealthcare.com. This news release includes a forward-looking statement within the meaning of the "Safe Harbor" provisions of Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 regarding commencement of shipments of AVEA. This forward-looking statement is based on current expectations and involves inherent risks and uncertainties, including important factors that could delay, divert, or change the expectations for AVEA and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, market factors, internal research and development initiatives, partnered research and development initiatives, competitive product development, marketing initiatives, governmental regulations and legislation, patent positions and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . For further details and a discussion other risks and uncertainties that may change VIASYS' expectations, see the company's Annual Report on Form 10-K for the year ended Dec. 29, 2001, which is on file with the Securities and Exchange Commission. VIASYS undertakes no obligation to publicly update this forward-looking statement, whether as a result of new information, future events, or otherwise. |
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