NxStage Medical, a healthcare products manufacturer based in Lawrence, Massachusetts, announced that it received CE Mark approval from the European Union for nighttime use of its System 1 device. The System 1 is a home hemodialysis device. According to a press release by the company, NxStage plans to commercialize the device in the E.U. in the later part of 2013.
In its press release, the company detailed the benefits of its System 1. By operating a dialysis at night three to five times weekly, it’s possible to increase a patient’s time in dialysis while having a minimal impact on patient and caregiver quality of life. However, nocturnal dialysis does carry some risks that aren’t associated with daytime dialysis.
Jeffrey Burbank is the CEO of NxStage. In prepared remarks, he said, “NxStage's nocturnal indication shows the company's leadership in safety and ease of use by minimizing those risks to the satisfaction of regulators.” He continued, "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.”
The company also stated that it is currently pursuing approval in the United States with a clinical trial. As of now, the System 1 is cleared for daytime home dialysis by the U.S. Food and Drug Administration.
In early February, William Blair & Company increased its stake in NxStage by 20 percent. The company is slated to release its fourth quarter and annual results on February 28th.
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