Landmark comparative study supports more frequent hemodialysis

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.