Interim results from FREEDOM study announced by NxStage Medical

NxStage Medical, Inc.Oct 27 2009

LAWRENCE, Mass., Oct. 27 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim results from its ongoing FREEDOM study. The FREEDOM data will be presented in posters at the American Society of Nephrology (ASN) Renal Week 2009, from October 27th to November 1st in San Diego.

The FREEDOM analysis shows a significant reduction in the need for anti-hypertensive medications experienced by patients performing daily home hemodialysis (DHD) therapy with the NxStage System One(TM), and this reduction was maintained through the twelve month study period. These interim results from the FREEDOM study compared the number of anti-hypertensive medications (used to control blood pressure) that were prescribed at the patients' baseline (when they were on thrice-weekly, in-center hemodialysis), then at 4-months and 12-months after starting DHD. The study also looked at the number of patients who were not prescribed anti-hypertensive medications at those intervals. Key findings include:

• A nearly 50% reduction in the average number of prescribed anti-hypertensive medications over 12 months;
• 33% of patients completely discontinued anti-hypertensive medications; and,
• 56% of patients experienced a 50% or greater decrease in anti-hypertensive medications.

Additional FREEDOM data demonstrates a 40% reduction in expected mortality of patients using daily home hemodialysis (DHD) therapy with the NxStage System One when compared to patients from the United States Renal Data System (USRDS). The Standardized Mortality Ratio (SMR), calculated from actual vs. expected deaths, was 0.6 for DHD patients compared to patients from the USRDS of similar age, gender, race and primary cause of ESRD.

"In an attempt to see if the decreased morality observed in the study would remain after statistical adjustment, this analysis utilized a well-established formula with conservative assumptions to calculate a SMR. Even after correcting for these variables, patients using daily home hemodialysis therapy with the System One experienced a significantly lower rate of death when compared to similar patients from the USRDS database," stated Brent Miller, M.D., an Investigator involved with the study from Washington University in St Louis. "This is further clinical evidence that more frequent home hemodialysis can lead to better clinical outcomes. These results should help energize patients, nephrologists, healthcare providers and public policy makers to continue to invest in and advance this therapy to alleviate the burden of dialysis."

Full abstracts can be read online at www.asn-online.org.