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Data Published in the Journal of the American Society of Nephrology Shows Daily Home Hemodialysis Patients with the NxStage System One Have Significantly Lower Risk of Mortality and Improved 3-Year Survival Versus Patients on Conventional Hemodialysis

LAWRENCE, Mass., Feb. 23, 2012 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today commented on findings of the Chronic Disease Research Group (CDRG) study which shows patients using the NxStage System One™ for daily, or more frequent, home hemodialysis, experienced a 13 to 18 percent lower risk of mortality and higher 3-year survival compared with that of patients treated with center-based conventional, thrice-weekly dialysis. The CDRG paper, "Mortality in Daily Home Hemodialysis and Matched Thrice-Weekly In-center Hemodialysis Patients" was published online on the Journal of the American Society of Nephrology (JASN) website in advance of its release in print. CDRG evaluated 1,873 NxStage daily home hemodialysis patients and 9,365 in-center patients over a three year period. CDRG is a nonprofit division of the Minneapolis Medical Research Foundation committed to investigating chronic illness to improve public health.

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The retrospective cohort study is the largest to date examining all-cause and cause-specific mortality and three-year survival of daily home hemodialysis patients using the NxStage System One compared with a matched cohort of in-center hemodialysis patients from the United States Renal Data System (USRDS) database. The study is also the most rigorously matched of its kind, leveraging 17 matching criteria including first date of follow-up, demographic characteristics, disease severity measures, transplant waiting list and other severity of disease covariates that could impact mortality. The study demonstrated that in the intention-to-treat analysis:

  • the all-cause mortality hazard ratio was 0.87 (p=0.01) in as-treated patient analyses when compared with patients receiving conventional thrice-weekly in-center dialysis,
  • the cause-specific mortality hazard ratios were 0.92 (p=0.34) for cardiovascular disease; 1.13 (p=0.41) for infection; 0.63 (p=0.03) for cachexia/dialysis withdrawal; 1.06 (p=0.69) for other specified cause; and 0.59 (p<0.01) for unknown cause. For this study, hazard ratios of <1 indicate reduced risk of death, whereas ratios of >1 indicate a greater risk.  Mortality results in the study are associated with a reduced risk of death from cachexia/dialysis withdrawal and unknown causes.

"This study is the largest and most comprehensively matched to date looking at survival in the daily home hemodialysis population, and the positive results are encouraging," said Dr. Allan Collins, MD, FACP, professor of medicine, University of Minnesota, and director, Chronic Disease Research Group. "These results add to the recently published body of large, well conducted studies pointing to significant potential benefits of home and more frequent hemodialysis therapies. Going forward, we must consider the possibility that conventional thrice-weekly treatment may be inadequate for addressing the critical problems of persistent fluid overload, hypertension, and left ventricular hypertrophy, as well as the resultant complications including patient mortality."

"This study uses the best statistical methods available and clearly demonstrates that more frequent home hemodialysis with the NxStage System One can significantly lower mortality and improve survival for thousands of dialysis patients," said Jeffrey H. Burbank, Chief Executive Officer of NxStage.

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. http://www.nxstage.com/.

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, 2011. 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

SOURCE NxStage Medical, Inc.

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