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New Data from KIHDNEy Cohort Shows Improved Biochemical Outcomes and Broad Range Patient Suitability with More Frequent Hemodialysis Using the NxStage System One

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News provided by

NxStage Medical, Inc.

02 Jun, 2017, 12:00 GMT

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Data presentations to be showcased at the 54th ERA-EDTA Congress

LAWRENCE, Massachusetts, June 2, 2017 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading medical technology company focused on advancing renal care, today announced new findings demonstrating positive biochemical outcomes related to more frequent hemodialysis with the NxStage® System One™. The data will be presented at the ERA-EDTA Congress being held June 3-6, 2017, in Madrid, Spain.

The research was conducted by the Knowledge to Improve Home Dialysis Network in Europe (KIHDNEy) Cohort team with two poster presentations by lead authors Drs. Maxence Ficheux, Nephrologist, CHR Clémenceau, Caen, France and Roberto Corciulo Nephrologist, Azienda Ospedaliero-Universitaria Policlinico, Bari, Italy, as well as, symposium presentations by Dr. Sunita Nair, Consultant Nephrologist and Clinical Lead, Home Dialysis Therapy Shrewsbury and Telford NHS Trust, UK, outlining the KIHDNEy Cohort, 12-month results, and Pr. Eric Goffin Nephrologist and Clinical Lead, Cliniques Universitaires Saint Luc, Brussels, Belgium, focusing on mineral and bone disorders. Conference attendees can meet with NxStage representatives in booth 3.155.

Oral presentations will occur on Sunday, June 4th at 6:45 p.m. CEST during the symposium, More Frequent HD Improved Outcomes: The Wish Comes True At Home, chaired by Drs. Natalie Borman, Medical Director, Consultant Nephrologist, Wessex Renal and Transplantation Unit, Portsmouth, UK, and Maria-Auxiliadora-Bajo, Nephrologist, Hospital Universitario La Paz, Madrid, Spain. Also during the symposium, Matthew Herbert, a NxStage patient from the United Kingdom, will discuss his dialysis journey and experiences on home nocturnal hemodialysis with the NxStage System One.

Of the 11 KIHDNEy researchers 3 of the contributors will be in attendance to present data, from the 182 patients across 9 renal units in 5 countries, highlighting the clinical benefits of more frequent home hemodialysis, including:

  • Improved control of fluid volume and good clearance of solutes:
    • Low ultrafiltration rate,
    • Reduction in antihypertensive medications,
    • Adequate dose of dialysis.
  • Stable mineral and bone disease parameters, along with improved albumin
  • Good preservation of residual renal function

"Data continues to reaffirm that more frequent hemodialysis with the System One provides better health outcomes for a broad spectrum of dialysis patients," said Allan Collins, Chief Medical Officer, NxStage Medical. "We are excited to be sharing this data with the international renal care community and look forward to working together to provide greater patient access to this life-changing therapy option."

The NxStage System One is a simple, flexible and portable hemodialysis system that provides a wide range of dialysis therapy options, including home, more frequent, and nocturnal dialysis. Visit nxstage.com for more information on therapy options with the System One.

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.

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. The 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-site on-demand. Unlike conventional hemodialysis systems, the System One family of products 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. In addition, NxStage's Nx2me Connected Health® platform collects important NxStage System One and patient information for flexible viewing, monitoring and reporting that may improve patient management and patient retention, as well as simplify alternative site care. 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 performance have been demonstrated by experience with more than 14 million treatments with over 30 thousand patients around the world. www.nxstage.com.

About NxStage Medical
NxStage Medical, Inc. (Nasdaq: NXTM) is a leading medical technology company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of end-stage renal disease (ESRD) and acute kidney failure. NxStage also has established a small number of dialysis clinics committed to the development of innovative care delivery models for patients with ESRD. For more information on NxStage and its products and services, please visit the Company's websites at www.nxstage.com and www.nxstagekidneycare.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 its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. 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 

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