NxStage Medical, Inc. (NXTM) Announces CE Mark Approval for Nocturnal Home Hemodialysis
2/21/2013 7:23:00 AM
LAWRENCE, Mass., Feb. 21, 2013 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced CE Mark approval for new high flow capabilities with the NxStage System One. With this approval, the Company expects to bring this advancement to customers in countries that recognize the CE Mark approval process later this year.
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The new high flow capabilities for the System One will enable dialysate flow rates which allow nephrologists expanded possibilities to adjust the duration and frequency of patient prescriptions with greater flexibility than they have today.
"Our new high flow capabilities advance the therapeutic flexibility of the System One as well as NxStage's leadership in home therapies," said Jeffrey Burbank, Chief Executive Officer, NxStage Medical, Inc. "By providing expanded therapy options, high flow enables NxStage therapy to be even better tailored to the clinical and lifestyle needs of a broader range of patients."
About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration (FDA). Its simplicity and revolutionary size (just over a foot tall) provide convenient use in patients' homes and give patients the freedom to travel with their therapy. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, at home or on the road.
About NxStage Medical Inc.
NxStage is a medical device company, headquartered in Lawrence, MA, USA, which develops, manufactures, and markets innovative systems for the treatment of end-stage renal disease (ESRD), and acute kidney failure. The System One home hemodialysis device developed by NxStage is the only FDA approved portable hemodialysis machine cleared for home use. For more information on NxStage, or NxStage products, visit, http://www.nxstage.com.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage's filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE NxStage Medical, Inc.
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