LAWRENCE, Mass., Nov. 22, 2010 /PRNewswire via COMTEX/ — NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today commented on the just- released findings of the Frequent Hemodialysis Network (FHN) Daily Trial that compared in-center hemodialysis administered under a three times per week schedule (conventional dialysis) versus six shorter sessions per week (short daily dialysis). The FHN Daily Trial, published in the New England Journal of Medicine, was a landmark, randomized, controlled study sponsored by the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) and the Centers for Medicare and Medicaid Services (CMS).
This study provides compelling evidence in support of more frequent hemodialysis, and of the important clinical benefits that short daily dialysis provides to dialysis patients versus the conventional dialysis schedule, said Jeffrey H. Burbank, President and Chief Executive Officer, NxStage Medical, Inc. NxStage applauds the researchers from the FHN, along with the NIDDK and CMS, for committing to this landmark comparative study. Chronic kidney failure is devastating in both human and economic terms. We are hopeful that these results will improve patient access to this important therapy and accelerate the creation of reimbursement for frequent dialysis that is simple, predictable, and appropriate.
We are pleased these findings align with the published results of our ongoing FREEDOM (Following Rehabilitation, Economics, and Everyday Dialysis Outcome Measurements, clinicaltrials.gov number NCT00288613 http://www.nxstage.com/freedomstudy/index.cfm) study of short daily dialysis using the NxStage System One® in the home, particularly with respect to physical health, improved control of hypertension, and a lower-than-expected mortality, stated Burbank.
Study results on the FHN Daily Trial (which used standard in-center dialysis equipment) were published in the New England Journal of Medicine Online First (http://www.nejm.org/doi/full/10.1056/NEJMoa1001593) on November 20 to coincide with a presentation of the data at the American Society of Nephrology’s Renal Week 2010 in Denver, Colorado.
Among its published and presented findings, the FHN Daily Trial showed that short daily dialysis resulted in significant improvements in both of the study’s co-primary endpoints, a composite of mortality and change in left ventricular mass (as measured using cardiac magnetic resonance imaging) and a composite of mortality and physical health (as measured using the Rand 36-item health survey). In addition, the Trial demonstrated that short daily dialysis was associated with improved control of hypertension and hyperphosphatemia.
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/.
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. Examples of these forward-looking statements include statements as to the anticipated impact of the FHN Daily Trial on the number of patients prescribed to receive short daily dialysis in the future. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond NxStage’s control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance or achievements including market acceptance and demand for NxStage’s System One, growth in home hemodialysis, the actual results demonstrated in the FREEDOM study, and certain other factors that may affect future operating results and which are detailed in NxStage’s filings with the Securities and Exchange Commission, including Quarterly Report on Form 10Q for the quarter ended September 30, 2010.
In addition, the statements in this press release represent NxStage’s expectations and beliefs as of the date of this press release. NxStage anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while NxStage may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events, or otherwise. These forward-looking statements should not be relied upon as representing NxStage’s expectations or beliefs as of any date subsequent to the date of this press release.
CONTACT: Kristen Sheppard of NxStage Medical, Inc., +1-978-332-5923, firstname.lastname@example.org
SOURCE NxStage Medical, Inc.