Massachusetts-based dialysis devices maker NxStage Medical (NSDQ:NXTM) won FDA clearance for its OneSite technology, cutting down on the number of needles dialysis patients must endure during therapy.
The OneSite needle features a dual lumen design that eliminates the need for a 2nd needle during hemodialysis. The system also features an alert system and sounds an alarm and shuts off therapy if the needle becomes dislodged.
"FDA clearance for OneSite is another significant milestone that illustrates the success of our innovation strategy. It represents a meaningful step forward in advancing the care of dialysis patients and will enhance the safety for our home dialysis patients," company president Joseph Turk said in prepared remarks. "Building on our breadth of technology and expertise in fistula needles, we’re bringing to market an elegant single needle solution that does not have the complexity and complications of other common approaches."
NxStage calls its flagship System One the "1st and only truly portable hemodialysis system" on the U.S. market. The device is indicated for home use and is designed to be portable, allowing patients to take their therapy with them when they travel.
The company has had a few strong quarters, reporting record results in Q2 2014 and boosting its full-year guidance.
NXTM shares have been going strong as well. The stock was up 3.7% today to trade at $13.97 as of about 4:30 p.m. EST. NXTM shares have gained nearly 40% since the start of this year.