NxStage Medical (NSDQ:NXTM) said it won CE Mark approval in the European Union for its System 1 home hemodialysis device, saying it expects to begin marketing the device for that indication in the 2nd half of this year.
The approval is a "significant milestone" for the Lawrence, Mass.-based medical device company, CEO Jeffrey Burbank said in prepared remarks.
"This approval gives us the unique ability to offer patients and nephrologists greater therapeutic flexibility and an expanded paradigm for dialysis treatment with the System 1," Burbank said.
NxStage said nocturnal dialysis performed 3 to 5 times a week increases the time spent on dialysis without increasing its impact on patients and caregivers, conferring advantages but also carrying different risks.
"NxStage’s nocturnal indication shows the company’s leadership in safety and ease of use by minimizing those risks to the satisfaction of regulators," according to a press release.
NxStage said it’s running a U.S. clinical trial for nocturnal dialysis with the System 1, hoping for a nod from the FDA to market the device for that indication on this side of the pond. System 1 is cleared for daytime home dialysis in the U.S.
Earlier this month, William Blair & Co. added 20% to its stake in NxStage, which is slated to release its 4th-quarter and 2012 results Feb. 28. NXTM shares gained some 13% in November after it revealed record-setting Q3 numbers.
NXTM shares were trading at $11.73 as of about 11:15 this morning, up 1.0%.