Healthcare Industry News: obstructive sleep apnea
News Release - September 21, 2006
Vital Signs, Inc. Announces FDA Clearance to Market Sleep and Ventilation ProductsTOTOWA, NJ--(Healthcare Sales & Marketing Network)--Sep 21, 2006 -- VITAL SIGNS, INC. (NASDAQ:VITL ) today announced that Breas Medical AB, a wholly owned subsidiary of Vital Signs, has received clearance by the U.S. Food and Drug Administration to market several of Breas' iSleep(TM) sleep products for the treatment of obstructive sleep apnea and VIVO(TM) ventilation products for the treatment of respiratory disorders. The products covered by the FDA clearance action include the iSleep10; iSleep 20; and iSleep 20+ for the treatment of obstructive sleep apnea; and the VIVO 30 in addition to the previously cleared VIVO 40. The VIVO line of products is indicated for use by patients who may benefit from non-invasive ventilation. The Breas HA01 humidifier, an integral accessory for use with these sleep and ventilation products, has also been cleared separately.
Terry Wall, CEO and Chairman of Vital Signs, stated, "The clearance to market the Breas iSleep line adds significant depth to our commitment to treat obstructive sleep apnea. We plan to introduce these products through the sleep network developed by our subsidiary, Sleep Services of America, Inc. ("SSA"). These products will be offered in conjunction with the CPAP products of other manufacturers. SSA expects to begin this new business initiative in the second half of fiscal 2007. We believe this expansion opportunity will improve patient care, as well as the performance of Vital Signs' sleep business."
All non-historical statements in this press release, including any statements regarding future sales, profitability and introduction of new products, constitute Forward-Looking Statements under the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from such statements as a result of a variety of risks and uncertainties, including unanticipated delays in bringing products to market, regulatory approval of new products, market conditions, and competitive responses as well as other factors referred to by Vital Signs in its Annual Report on Form 10-K for the year ended September 30, 2005.
Vital Signs, Inc. and its subsidiaries design, manufacture and market primarily single-use medical products for the anesthesia, respiratory/critical care and sleep/ventilation markets. In addition, Vital Signs provides pharmaceutical technology services to the pharmaceutical and medical device industry. Vital Signs is ISO 13485 certified and has CE Mark approval for its products.
Source: Vital Signs, Inc.
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