, Feb. 19, 2013
/PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced CE Mark approval for nocturnal home hemodialysis with the NxStage System One. With CE Mark approval, the NxStage System One is continuing its leadership in home hemodialysis technology. NxStage expects to begin marketing the System One for nocturnal dialysis in countries that recognize the CE Mark approval process in the second half of 2013.
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Nocturnal dialysis, performed while the patient is sleeping, usually between three and five nights per week, allows much greater time on dialysis without additional inconvenience to the patient or their family. Dialyzing while sleeping has many benefits, but also unique risks; NxStage's nocturnal indication shows the Company's leadership in safety and ease of use by minimizing those risks to the satisfaction of regulators.
"This is an important milestone for NxStage as it provides another example of our leadership in home hemodialysis," said Jeffrey Burbank, Chief Executive Officer, NxStage Medical, Inc. "This approval gives us the unique ability to offer patients and nephrologists greater therapeutic flexibility and an expanded paradigm for dialysis treatment with the System One."
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.
The NxStage System One is not specifically cleared in the US for nocturnal home hemodialysis. The Company is currently in a trial to support this indication.
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.
SOURCE NxStage Medical, Inc.