Vital Signs, Inc., has received clearance from the US Food and Drug Administration to market several of Breas' iSleep sleep products for the treatment of obstructive sleep apnea and VIVO 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.