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New FREEDOM Data Adds to Compelling Evidence in Support of More Frequent Home Hemodialysis with NxStage System One
Date:11/10/2011

LAWRENCE, Mass. and PHILADELPHIA, Nov. 10, 2011 /PRNewswire/ -- Booth # 407 at The American Society of Nephrology (ASN)'s Kidney Week 2011 -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim results from its ongoing FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) study, showing patients experience a better overall quality of life while undergoing more frequent dialysis with the NxStage System One™, including more satisfaction with physical intimacy.  In addition, patients who had received more frequent dialysis with the System One for 12 months were clearly motivated and unlikely to consider returning to their prior dialysis modality.

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The ongoing FREEDOM study is the largest study of its kind to measure the clinical and economic benefits of daily home hemodialysis treatment, as compared to conventional, thrice-weekly in-center hemodialysis treatment for patients requiring dialysis therapy. The following interim results from the FREEDOM study were self-reported after a 12-month period. Specifically, significant improvements identified in this planned interim analysis included:

  • Patients reported a better overall quality of life (as reported on a 10-point Likert scale with 0 = worst, 10 = best).
    • The baseline score improved from 6.4 to 7.0. (Index: P<0.0001)
  • Patients reported more satisfaction with physical intimacy (as reported on a 10-point Likert scale with 0 = least satisfied, 10 = most satisfied).
    • The baseline score improved from 4.9 to 5.7. (Index: P=0.0005)
  • Finally, patients reported they are less likely to return to their prior dialysis regimen (as reported on a 10-point Likert scale with 0 = most likely to return, 10 = least likely to return).
    • The baseline score improved from 8.1 to 9.1. (Index: P=0.002)

Michael A Kraus, MD, Medical Director, Professor of Clinical Medicine and Clinical Coordinator, Division of Nephrology, Indiana University School of Medicine and Clarian Health Partners and presenter of the FREEDOM study data at Kidney Week 2011 said, "The data we presented once again show that patients benefit from daily home hemodialysis over an extended period of time. Not only is it significant that patients are seeing marked improvements in their health and quality of life, but they are making the decision to stay with this life-changing treatment option."

At this year's Kidney Week, significant attention is being paid to the growing clinical practice and need for more frequent hemodialysis. More than 20 oral presentations, posters, abstract publications and other courses of interest on topics such as prescription considerations, clinical outcomes, practical considerations and future directions will be discussed at this influential meeting.

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) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy.   When combined with the NxStage Pureflow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand.  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 vacation.

About NxStage Medical

NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative systems for the treatment of end-stage renal disease, or ESRD, and acute kidney failure. NxStage is leading the development of the home hemodialysis market in the US with the only portable hemodialysis machine, the System One, cleared for home use by the FDA. For more information on NxStage and its products, please visit the company's website at http://www.nxstage.com/.

Forward-Looking Statements

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, 20011. 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.

Kristen K. Sheppard, Esq.
VP, Investor Relations
ksheppard@nxstage.com


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SOURCE NxStage Medical, Inc.
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