UPDATED Feb. 19, 2:00 p.m. with comments from NxStage CEO Jeff Burbank.
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 in some of the 32 nations that recognize the mark.
The approval is a "great step forward" for the Lawrence, Mass.-based medical device company, CEO Jeffrey Burbank told MassDevice.com today.
"There are significant clinical advantages and lifestyle advantages that can be accrued through this therapy. In essence what it can do for patients is reduce the burden of doing it during the day. Logistically, it reduces some of the burden on patients," Burbank told us during a phone interview today. "There’s a clinical difference to it, because you deliver the therapy over a longer period of time."
"It seems to be a gentler therapy as well, he added. "In many cases, patients can have a more liberal diets and eat some foods they haven’t been able to eat."
NxStage is hoping to grab 10%-15% of the overall dialysis market, Burbank said. The CE Mark "will help to get to higher numbers," he said, noting that the company plans to roll the System 1 out for nocturnal use in "all of our CE Mark markets – the U.K., Scandinavia, the Netherlands, France, Italy and Germany.”
One risk of the nocturnal System 1 therapy compared with daytime use is that, "obviously no one is watching," Burbank said, creating the risk of an unnoticed fluid spill.
"With the technology we’ve put around this clearance, we feel those risks are appropriately mitigated," he told us.
Kristen Sheppard, NxStage’s vice president for investor relations, told MassDevice.com in an email that the company believes it’s "the 1st and only company with an indication for home hemodialysis in the EU."
Burbank wouldn’t specify how many subjects the company has enrolled in a U.S. trial aimed at an FDA OK for the sleep indication, saying that although "it’s not a tremendous amount of patients" the trial will generate "a tremendous amount of data."
"It’s a very comprehensive trial, because we’re capturing the data from each treatment," he explained. "We continue making progress and continue to see very encouraging results. We’re obviously very encouraged and excited [by the CE Mark approval] and can’t wait to finish up the trial and get the [nocturnal dialysis] technology to 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 $11.75 as of about 2 p.m. today, up 1.4%.