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New Data Show Improved Survival, Reduced Cardiovascular Hospital Readmissions, and Increased Transplantation on Home Hemodialysis with the NxStage System One
Date:3/25/2015

LAWRENCE, Mass., March 25, 2015 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq:  NXTM), a leading manufacturer of dialysis products, today announced the presentation of four new abstracts demonstrating clinical outcomes during the National Kidney Foundation's Spring Clinical Meeting in Dallas, Texas. Three of the abstracts highlight improved survival, reduced cardiovascular hospital readmissions, and increased transplantation for daily home hemodialysis (DHHD) patients using the NxStage® System One™ versus other modalities. The fourth abstract details results from the Company's groundbreaking study that led to the clearance of the System One as the first and only hemodialysis machine cleared for home nocturnal hemodialysis (home NHD).

The first three abstracts derive from work conducted by Eric Weinhandl, MS, PhD candidate and Dr. Allan Collins of the Chronic Disease Research Group (CDRG), funded by NxStage. These show:

  • 29% lower risk of death for incident patients using DHHD vs. patients receiving conventional in-center hemodialysis (IHD),
  • 15% lower risk of 30-day readmission after hospitalization for heart failure than peritoneal dialysis (PD) patients and 27% lower than IHD patients, and
  • 37% greater incidence of transplant for DHHD patients than PD patients, and 22% greater than IHD patients.

The fourth abstract presented at the meeting, from a NxStage-funded registration trial led by Dr. Brigitte Schiller of Satellite Healthcare and Dr. Brent W. Miller of Washington University in Saint Louis, Missouri, details favorable results of 58 ESRD patients receiving home NHD with the NxStage System One. The study demonstrated results of increased clearance, improved phosphorus control, and comparable safety and efficacy to DHHD. The open-label, prospective, two-treatment, two period crossover, non-inferiority study enrolled, trained, and transitioned DHHD patients to home NHD, and subsequently treated them for eight weeks on home NHD.

"These new data continue to highlight the benefits, safety, and efficacy of daily home hemodialysis with respect to important, long intractable challenges not fully addressed by conventional dialysis.  The complete alignment of randomized, observational, and epidemiological studies with respect to daily hemodialysis benefits is compelling," said Collins, Director of the Chronic Disease Research Group and Senior Medical Advisor for NxStage. "Moreover, showing that nocturnal hemodialysis may be administered in the home with relative safety and efficacy to gain the first-ever clearance in the U.S. for this indication represents a major milestone in the treatment of kidney disease."

"NxStage has long been committed to product innovation and quality clinical research to help improve the lives of patients with kidney failure," said Joe Turk, President of NxStage Medical. "We are delighted that these data will be shared in these important clinical sessions, so that awareness and understanding increase and more patients and their families may ultimately gain access to this life-changing therapy."

The posters, numbers 278, 279, 280, and 338, will be presented on Thursday, March 26, 2015 from 6:00 - 7:30pm and remain on display at the Gaylord Texan through Saturday, March 28, 2015.

Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.

Additional Risks Associated with Nocturnal Home Hemodialysis Therapy
The NxStage System One may be used at night while the patient and care partner are sleeping. Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow or increased treatment time or both, and delayed response to alarms when waking from sleep. Ancillary anticoagulant infusion pumps and fluid leak detection devices may be used to decrease certain risks for home hemodialysis treatments performed at any time, but NxStage requires the use of fluid leak detectors to identify leaks from the vascular access, Cycler and Cartridge when performing nocturnal therapy with the NxStage System One.

About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system 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 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, including while they are sleeping - at home or on vacation and at a medically appropriate treatment frequency. 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 Annual Report on Form 10-K for the year ended December 31, 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.                                   

Media contact: 
Kristen K. Sheppard, Esq.
ksheppard@nxstage.com
Tel: (978) 332-5923

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