FREEDOM Study Data: Patients Experience Sustained Quality of Life Benefits with More Frequent Home Hemodialysis with the NxStage System One
LAWRENCE, Mass., May 24, 2012 /PRNewswire/ -- NxStage ® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim findings from its FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study, which found daily home hemodialysis treatments with the NxStage System One™ are associated with long-term improvements in various physical and mental quality of life measures. These interim FREEDOM Study results, "At-Home Short Daily Hemodialysis Improves the Long-Term Health-Related Quality of Life," were published online on Kidney International's website in advance of its release in print.
NxStage's FREEDOM Study is the largest prospective study of frequent home hemodialysis to date. The FREEDOM Study reported improvements in several quality of life measures in end stage renal disease (ESRD) patients at 12 months of follow-up, including:
- Sustained improvements in the physical-component summary (PCS) score and mental-component summary (MCS) score at four and 12 months;
- Significant improvements in all six PCS-specific domains (physical functioning, role physical, bodily pain, general health, vitality and social functioning) and one of two MCS-specific domains (mental health) over 12 months; and
- More than doubling the proportion of participants with a PCS score greater than or equal to 50, increasing from nine percent at baseline to 21 percent at 12 months in the as-treated cohort.
"Today's data shows more frequent home hemodialysis unlocks a variety of clinical and quality of life benefits for ESRD patients that remain over an extended period of time," said Frederic Finkelstein, MD, Chief of Nephrology at the Hospital of St. Raphael in New Haven, Conn. and Clinical Professor of Medicine at Yale University Medical School, as well as the study's primary author. "ESRD patients struggle on a daily basis with maintaining their overall health while trying to better manage their chronic condition. This data shows that more frequent home hemodialysis can have a positive impact on a patient's perception of his quality of life."
"This recent data builds upon an already robust mountain of clinical evidence pointing to the benefits of more frequent home hemodialysis," said Jeffrey H. Burbank, Chief Executive Officer of NxStage Medical, Inc. "FREEDOM continues to show that more frequent home therapy with the NxStage System One transforms patient lives for the better, resulting in healthier, happier patients who are empowered in their own healthcare."
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 ESRD and acute kidney failure. 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. 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 March 31, 2012. 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
SOURCE NxStage Medical, Inc.
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