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PHYX Physiometrix (MM)

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Physiometrix (MM) NASDAQ:PHYX NASDAQ Common Stock
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Physiometrix, Inc., Announces FDA Clearance Of Its Next Generation Monitor

10/02/2004 1:00pm

PR Newswire (US)


Physiometrix (NASDAQ:PHYX)
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Physiometrix, Inc., Announces FDA Clearance Of Its Next Generation Monitor NO. BILLERICA, Mass., Feb. 10 /PRNewswire-FirstCall/ -- Physiometrix, Inc. announced today that it has received clearance from the Food and Drug Administration (FDA) for commercial distribution of its PSA 5000 next generation monitor. The PSA 5000 is a new state of the art monitor that is more powerful, cost effective and ergonomic than it's predecessor the PSA 4000. The company anticipates launch of the product through its exclusive distribution partner, Baxter Healthcare, later this year. "This very rapid response by FDA reflects positively on the strength of our regulatory team at Physiometrix and we are most enthusiastic about the potential of our new next generation monitor," said John A. Williams, president and chief executive officer. "This innovative new platform allows level of consciousness monitoring to be done conveniently anywhere in the hospital setting, including the operating room and intensive care unit. Feedback from clinicians has been superlative and we eagerly await the launch with our partners at Baxter Healthcare," Williams concluded. Designed for use by anesthesiologists, the PSA 4000 / 5000 is a device that enables an anesthesiologist to monitor and manage a patient's level of consciousness under anesthesia in the operating room and intensive care unit. The PSA 4000 / 5000 has the potential to enhance patient care and improve recovery times in hospitals across the U.S. and around the world. Physiometrix, Inc. designs, manufactures and markets noninvasive medical products -- based on novel gel materials, sophisticated signal-processing electronics technologies, and proprietary software -- for use in anesthesia- monitoring during surgical procedures. Safe Harbor Statement Statements in this press release regarding Physiometrix's growth and future business results of the Company are "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. Such statements are based upon management's current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors that could cause actual results to differ materially from any forward-looking statements made by the Company include, among others, revenue estimates, dependence on existing and future products, uncertainty of market acceptance, intense competition, partnership agreements, and government regulations, especially regulatory approvals. Other relevant risks are described in the Company's Form 10-K filed March 28, 2003 and Form 10Q dated November 14, 2003, with the SEC. CONTACT: Daniel W. Muehl, CFO Physiometrix Inc. 978-670-2422 DATASOURCE: Physiometrix, Inc. CONTACT: Daniel W. Muehl, CFO, Physiometrix Inc., +1-978-670-2422 Web site: http://physiometrix.com/

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