Positive interim results from NxStage Medical's FREEDOM study in RLS

Booths # 23-25 at the Annual Dialysis Conference -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim results from its ongoing FREEDOM study, which show the significant improvement of overall sleep quality and marked improvement in Restless Legs Syndrome (RLS) experienced by patients after four months of daily home hemodialysis therapy with the NxStage System One™.

These interim results from the FREEDOM study compared patients' responses to the Medical Outcomes Study (MOS) Sleep Survey and the International RLS Study Group Rating Scale (IRLS) at baseline and four months. Specifically, significant improvements identified in this planned interim analysis included:

  • Overall sleep quality (as measure by the MOS Sleep Problems Indices I and II) significantly improved from baseline to month four. (Index I:>
  • Four of the 5 individual sleep scale s– sleep adequacy, daytime somnolence (or "drowsiness"), sleep initiation and maintenance, and respiratory disturbances – displayed significant improvement.
  • There was a significant reduction in the number of patients reporting RLS at 4 months compared to baseline.>
  • Of those patients who experienced RLS at baseline>

Dr. Brigitte Schiller, MD, Acting Chief Medical Officer and Vice President of Scientific Affairs for Satellite Healthcare headquartered in Mountain View, CA, is one of the presenters of FREEDOM study data during the 30th Annual Dialysis Conference in Seattle.

"Various studies suggest a high prevalence of sleep-related disorders and RLS, among End-stage Renal Disease (ESRD) patients. These interim results from the ongoing FREEDOM study demonstrate the positive impact of daily home hemodialysis on these disorders, which can have a significant impact on patients' quality of life," says Dr. Schiller. "Quality sleep is essential, and to ESRD patients in particular, as it has been proven to affect other areas of patients' overall health. Although these findings are only at four months, longer-term follow up is underway to determine whether the positive impact of daily home dialysis on sleep patterns and RLS persists at one year."

"NxStage continues to invest in proving the wide range of clinical and quality of life benefits possible with more frequent hemodialysis," says Jeff Burbank, CEO of NxStage Medical, Inc. "These results add to the growing evidence supporting daily home hemodialysis with our System One versus conventional, thrice-weekly in-center therapy."

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. All daily home hemodialysis patients in the FREEDOM study use the NxStage System One as their treatment delivery system, and all have Medicare as their primary insurance payer.

SOURCE NxStage Medical, Inc.

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