NxStage Announces CE Mark Approval for Nocturnal Home Hemodialysis
LAWRENCE, Mass., Feb. 19, 2013
LAWRENCE, Mass., 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.
(Logo: http://photos.prnewswire.com/prnh/20110503/MM94799LOGO )
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 theU.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
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.
Contact: Kristen Sheppard, +1-978-332-5923, firstname.lastname@example.org
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