New NxStage® FREEDOM Data Shows Continued, Marked Benefits for Patients Using the System One™ for Daily Home Hemodialysis Throughout a 12 Month Period
LAWRENCE, Mass. and PHOENIX, Feb. 20, 2011 /PRNewswire/ -- 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 an increase in overall quality of life benefits, significant improvement in overall sleep quality and a marked improvement in Restless Legs Syndrome (RLS) symptoms experienced by patients after 12 months of daily home hemodialysis with the NxStage System One™. The study results were presented during the Annual Dialysis Conference in Phoenix, Arizona. 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.
"These latest 12-month results are extremely encouraging. The analysis shows the quality of life benefits eligible patients experience at month four continue and sometimes strengthen by month 12. These benefits are dramatic and can be truly life-changing," said Dr. 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 an investigator on the FREEDOM study. "These improvements in mental and physical scores suggest that daily hemodialysis leads to an overall healthier and happier patient."
The interim analysis of the FREEDOM study shows that daily home hemodialysis is associated with clear improvements in quality of life benefits sustained throughout a 12-month period, as measured by the SF-36v2 Health Survey. Results show:
- Significant improvements in both mental health scores (Mental Component Summary) and physical health scores (Physical Component Summary) from baseline to month 12. (MCS: P=0.01; PCS<0.0001).
- Seven out of eight individual SF-36 domains – including physical functioning, bodily pain, general health, vitality, mental health and social functioning – showed clinically meaningful improvements.
RLS is a distressing neurological disorder characterized by an uncomfortable sensation in the legs, with an irresistible urge to move them. According to various studies, as many as 62% of end stage renal disease (ESRD) patients suffer from RLS which can disrupt their sleep. Additional 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 12 months. The 12-month data showed:
- Overall sleep quality (as measured by the MOS Sleep Problems Indices I and II) significantly improved from baseline to month 12. (Index I: P=0.001; Index II: P<0.001)
- Significant improvement in three of the individual sleep scales – sleep disturbances, daytime somnolence, and awaken short of breath or with a headache.
- A sustained improvement in the IRLS global score at four and 12 months compared to baseline (P<0.001).
- A significant reduction in the percentage of patients who experienced RLS after 12 months (35% vs 26%, p = 0.05). Of those patients experiencing RLS, there was a trend towards a reduction in the percentage of patients with moderate to severe RLS (59% vs 43%, p=0.06).
"The FREEDOM study is an important part of our ongoing commitment to enhance access to home hemodialysis," stated Joseph Turk, President North America of NxStage Medical. "We are delighted that the results continue to reinforce the life-changing benefits of daily home hemodialysis with the NxStage System One."
These 12-month interim results from the FREEDOM study have been accepted for publication in the Clinical Journal of the American Society of Nephrology (CJASN).
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.
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. For more information on NxStage and its products, please visit NxStage's website at 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 positive impact of the FREEDOM study on improving patient access to home and daily hemodialysis. 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, these and other factors are detailed in NxStage's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 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.
Kristen K. Sheppard, Esq.
SOURCE NxStage Medical, Inc.