LAWRENCE, Mass., April 12 /PRNewswire-FirstCall/ -- NxStage Medical, Inc. , -- today announced that it has received Food and Drug Administration (FDA) 510(k) clearance to market its PureFlow SL product and its first clinical use. This first generation device prepares high purity dialysate, which meets and exceeds dialysis industry standards for purity, from ordinary tap water in the dialysis patient’s home. This product is designed to help patients with end-stage renal disease more conveniently and effectively manage their home hemodialysis therapy by eliminating the need for bagged fluids.
“The PureFlow SL helps NxStage and our partners achieve a core objective -- making home hemodialysis therapy even more practical for all patients who might benefit. We are very pleased the FDA has cleared this novel technology and we look forward to its potential to improve quality of life and ease of use for patients performing home hemodialysis with the NxStage System One(TM),” said Mr. Jeff Burbank, President and Chief Executive Officer. “Initial patients began using the system this week, and we continue to be on track for a broad commercial release in July 2006,” continued Mr. Burbank.
“We applaud NxStage for continuing to innovate in ways that help us bring home hemodialysis to more patients,” said Cathy Cox, Home Program Coordinator at Clarian-Indiana University Hospital in Indianapolis, Indiana. “With this new product, NxStage has once again found a way to make it easier for patients to take control of their own therapy in the comfort of their own homes. This will be an essential part of how we treat patients at home -- patients will no longer need to store and hang bagged fluid with the PureFlow SL and with the System One’s portability, they can still travel using dialysate in bags.”
The NxStage PureFlow SL is an accessory to the NxStage System One designed to prepare ultra pure water from ordinary tap water, and mix this water with concentrate to produce high purity dialysate. With the push of a button, the PureFlow SL automatically produces a batch of dialysate fluid ready to use with the System One to perform home hemodialysis. The product is small in size (about the size of an end table) and is uniquely configured to overcome the ease of use, infrastructure, and purity limitations of more traditional water treatment systems.
The NxStage management will hold its next conference call starting at 9:00 am (EST) on Tuesday, April 25, 2006 to discuss the financial results for the first quarter as well as this and other commercial developments. To listen to the conference call, please dial (866) 831-5605 for domestic callers and (617) 213-8851 for international callers. The passcode is 45138569. A replay of the conference call will be available through May 2, 2006 by dialing 888-286-8010 (domestic) and 617-801-6888 (international), passcode 45742183. An online archive of the conference call will also be available by accessing the Investor Relations section of the company’s website at http://www.nxstage.com.
About NxStage Medical
NxStage Medical, Inc. 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 the company’s website at http://www.nxstage.com.
About End-Stage Renal Disease (ESRD)
End-stage renal disease (ESRD) is the permanent failure of the kidneys to filter the body’s wastes. It is most commonly caused by diabetes, hypertension, or genetic disorders. In order to survive, ESRD patients must use some form of therapy to replace the function of the kidneys for the rest of their lives. Currently, over 450,000 patients in the United States suffer from ESRD, and the costs of treating ESRD patients are over $20 billion annually in the U.S. Due to increases in diabetes, hypertension, and the aging of the U.S. population, those figures are projected to double within the next 10-15 years. The most common form of kidney replacement therapy in the United States today is hemodialysis, which is used by over 350,000 patients. The great majority of these patients are treated with conventional, in-center hemodialysis, in which they must travel to a nearby dialysis center three times per week, where they are connected to dialysis machines for treatments lasting approximately three to four hours, to cleanse their blood.
About Hemodialysis
Today, most patients undergo hemodialysis therapy three times a week in outpatient dialysis centers. This differs significantly from the 24/7 workings of the naturally functioning kidney. Increasingly, clinicians and patients have recognized opportunities for therapy improvements with more frequent, or daily, dialysis. Hundreds of clinical papers have reported on the health and quality of life benefits of hemodialysis done more frequently. The reported benefits include reduced hypertension, reduced cardiac strain and left ventricular hypertrophy, reduced amyloid disease, and improved anemia status, appetite, and quality of life, including the ability to return to work. A summary of the literature discussing these benefits can be found on NxStage’s website, http://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. Examples of these forward-looking statements include statements as to the anticipated commercial release date of the PureFlow SL, the anticipated design, features and benefits of the PureFlow SL, the anticipated market acceptance for the PureFlow SL, the growth of the ESRD patient population, the anticipated demand for home dialysis products, including NxStage’s products, and NxStage’s plans to hold a conference call on Tuesday April 26. 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, performance or achievements, including market acceptance and demand for the PureFlow SL or the NxStage System One, growth in home hemodialysis, and certain other factors that may affect future operating results and which are detailed in NxStage’s filings with the Securities and Exchange Commission, including Annual Report on Form 10K for the year ended December 31, 2005. 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.
Contact David N. Gill Senior Vice President & Chief Financial Officer 978-687-4700 dgill@nxstage.com
NxStage Medical, Inc.
CONTACT: David N. Gill, Senior Vice President & Chief Financial Officer ofNxStage Medical, Inc., +1-978-687-4700, dgill@nxstage.com
Web site: http://www.nxstage.com//
