xStage Receives FDA Clearance for Home Nocturnal Hemodialysis

NxStage Medical, Inc. (NASDAQ: NXTM), a leading manufacturer of innovative dialysis products, announced todaythat the U.S. Food and Drug Administration (FDA) has cleared its System One™to perform hemodialysis overnight while the patient is at home sleeping, knownas home nocturnal hemodialysis. NxStage's® System One is the first and onlyhemodialysis machine cleared by the FDA for this indication.NxStage Medical, Inc.Home nocturnal hemodialysis is an important patient option associated with anumber of lifestyle and clinical advantages. By doing therapy while sleeping,the patient frees up their day to pursue other activities therefore reducingthe overall burden of therapy. A longer, overnight therapy also allowsgreatly expanded flexibility in dialysis dose and schedule, better enablingphysicians to match the dialysis prescription to individual patient needs."For years, patients and physicians in the United States have been asking foran FDA-cleared home nocturnal hemodialysis option for the improved outcomesand quality of life the modality can deliver," stated Brigitte Schiller, M.D,Chief Medical Officer of Satellite Healthcare and Principal Investigator ofNxStage's home nocturnal hemodialysis trial. "I, along with my fellowinvestigators in this trailblazing trial, am pleased that we were able todemonstrate the NxStage System One can safely and effectively deliver thisimportant treatment option.""We are delighted with this milestone achievement, which we believe will openhome hemodialysis therapy to new segments of patients, and improve patientcare for ESRD patients by expanding therapeutic options and flexibility,"stated Jeffrey Burbank, Founder and Chief Executive Officer of NxStage. "This'first of its kind' clearance is the culmination of significant productinnovation, ongoing collaboration with the FDA, a rigorous clinical trial andour experience in delivering over 10 million treatments with the System Onearound the world."The Company is actively preparing for a full U.S. market launch in support ofthis expanded indication in 2015. The System One also is CE-marked for homenocturnal hemodialysis.