NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis

First-ever clearance of its kind in the US creates an important new option for patients and providers to perform home hemodialysis overnight while sleeping

Dec 22, 2014, 07:07 ET from NxStage Medical, Inc.

LAWRENCE, Mass., Dec. 22, 2014 /PRNewswire/ -- NxStage Medical, Inc. (NASDAQ: NXTM), a leading manufacturer of innovative dialysis products, announced today that the U.S. Food and Drug Administration (FDA) has cleared its System One™ to perform hemodialysis overnight while the patient is at home sleeping, known as home nocturnal hemodialysis. NxStage's® System One is the first and only hemodialysis machine cleared by the FDA for this indication.

Home nocturnal hemodialysis is an important patient option associated with a number of lifestyle and clinical advantages. By doing therapy while sleeping, the patient frees up their day to pursue other activities therefore reducing the overall burden of therapy.  A longer, overnight therapy also allows greatly expanded flexibility in dialysis dose and schedule, better enabling physicians to match the dialysis prescription to individual patient needs.

"For years, patients and physicians in the United States have been asking for an FDA-cleared home nocturnal hemodialysis option for the improved outcomes and quality of life the modality can deliver," stated Brigitte Schiller, M.D, Chief Medical Officer of Satellite Healthcare and Principal Investigator of NxStage's home nocturnal hemodialysis trial. "I, along with my fellow investigators in this trailblazing trial, am pleased that we were able to demonstrate the NxStage System One can safely and effectively deliver this important treatment option."

"We are delighted with this milestone achievement, which we believe will open home hemodialysis therapy to new segments of patients, and improve patient care for ESRD patients by expanding therapeutic options and flexibility," stated Jeffrey Burbank, Founder and Chief Executive Officer of NxStage. "This 'first of its kind' clearance is the culmination of significant product innovation, ongoing collaboration with the FDA, a rigorous clinical  trial and our experience in delivering over 10 million treatments with the System One around the world."

The Company is actively preparing for a full U.S. market launch in support of this expanded indication in 2015.  The System One also is CE-marked for home nocturnal hemodialysis.

About the NxStage System One
The NxStage System One is the first and only portable hemodialysis machine cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. 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. 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, including while they are sleeping - at home or on vacation and at a medically appropriate treatment frequency. The System One is also used to provide a range of flexible therapy options in more traditional care settings such as hospitals and dialysis centers. Its safety and efficacy have been demonstrated by experience with more than 10 million treatments with thousands of patients around the world. 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 products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at www.nxstage.com.

Forward-Looking Statements
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 September 30, 2014. 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 
ksheppard@nxstage.com

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SOURCE NxStage Medical, Inc.



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