NxStage: FDA Clearance for New High Flow Capabilities with NxStage System

[Zach]

NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One

http://ir.nxstage.com/releasedetail.cfm?ReleaseID=760385


April 30, 2013
NxStage Announces FDA Clearance for New High Flow Capabilities with NxStage System One
Product provides patients with benefits of home hemodialysis and greater treatment flexibility based on their clinical and lifestyle needs
LAWRENCE, Mass., April 30, 2013 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced that the U.S. Food and Drug Administration (FDA) has cleared new high flow capabilities with the NxStage System One™, the only truly portable hemodialysis system cleared for home use. With this clearance, the Company expects to begin offering its System One with new higher flow capabilities in the United States later this year.

(Logo:  http://photos.prnewswire.com/prnh/20110503/MM94799LOGO)

The new higher flow capabilities for the System One enable increased dialysate flow rates, allowing nephrologists expanded possibilities to adjust the duration and frequency of patient prescriptions. Patients can now enjoy the benefits of home hemodialysis and have even greater treatment flexibility based on their clinical and lifestyle needs.

"This latest regulatory milestone reflects strong and systematic execution against our product pipeline," said Jeffrey Burbank, Chief Executive Officer, NxStage Medical, Inc. "With this new capability, NxStage therapy may be prescribed less frequently, for example 3 times per week or every other day, at treatment times consistent with those that patients and physicians experience in-center today.  We're strong believers in longer and more frequent dialysis for the clinical benefits; still, high flow opens the NxStage solution more broadly to the patient segment that wants the benefits of home, but at in-center frequency."

NxStage's high flow capabilities also received CE mark approval in February 2013.

About NxStage Medical Inc.

NxStage is a medical device company, headquartered in Lawrence, MA, USA, which develops, manufactures, and markets innovative systems for the treatment of end-stage renal disease (ESRD), and acute kidney failure. The System One home hemodialysis device developed by NxStage is the only FDA approved portable hemodialysis machine cleared for home use. For more information on NxStage, or NxStage products, visit, 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. 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 Annual Report on Form 10-K for the year ended December 31, 2012. 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 Sheppard
ksheppard@nxstage.com

SOURCE NxStage Medical, Inc.

[Bill Peckham]

Interesting Zach, this is a good development.  I'm not sure what the dialysate flow rates will be with the new settings. From the press release they seem to suggest that they'll be able to provide the standard two times the blood flow rate - up to 800 ml/min which is standard on incenter machines.

If for instance you wanted to run for four hours every other day at a 350 ml/min blood pump speed, you'd want the machine to use a 700ml/min dialysate flow rate. That works out to the treatment using 168 liters of dialysate per treatment ... how are they going to provide 168 liters of dialysate. Hanging 34 bags seems impractical lol

In a perfect world the PureFlow would somehow be able to produce 700ml of ultrapure dialysate per minute but I can';t imagine how that could be done with the current device. I need more info.