Nephros, Inc. Receives CE Mark Approval for the OLpur MD 190; New Product Designed to Improve Treatment for End-Stage Renal Disease; European Sales to Commence Immediately.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--Oct. 14, 2003 Nephros, Inc, an innovative developer and provider of advanced End Stage Renal Disease Renal disease Kidney disease. Mentioned in: Glycogen Storage Diseases hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg (ESRD ESRD end-stage renal disease. ESRD End-stage renal disease; chronic or permanent kidney failure. Mentioned in: Dialysis, Kidney ESRD End-stage renal disease, see there ) therapy technology and products, today announced that it has received CE Marking for its OLpur(TM) MD 190, an advanced proprietary filter designed for use in hemodiafiltration (HDF (Hierarchical Data Format) A file format for scientific data that is developed and maintained by NCSA. Governments and research organizations around the world use HDF for archiving and distributing collected data. HDF - Hierarchical Data Format ) therapy. Receipt of the CE Marking indicates that the OLpur(TM) MD 190 meets European medical device standards and allows Nephros to market the OLpur(TM) MD 190 within the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . The OLpur(TM) MD 190, an advanced proprietary filter designed for use in HDF therapy, uniquely combines post-dilution and pre-dilution diafiltration into one simple-to-use device. The OLpur(TM) MD 190 has a unique design that achieves the superior urea clearance urea clearance n. The volume of plasma or blood that would be completely cleared of urea by one minute's excretion of urine. of post-dilution hemodiafiltration, while offering unsurpassed clearance of toxins in the middle-molecule range. The OLpur(TM) MD 190 functions on all current HDF machines, with no special accommodations required. "We're pleased to have reached this significant milestone," said Norman Barta, president and chief executive officer of Nephros. "We're looking forward to providing nephrologists and their patients in the European Union with the first filter designed specifically for hemodiafiltration. Based on our initial feedback from leading nephrologists, we believe that there will be a strong reception for this innovative, easy-to-use device in light of its potential to improve survival, increase the quality of life, and reduce medical costs for the ESRD patient." Nephros expects to commence sales of the OLpur(TM) MD 190 in Europe in the 4th quarter of 2003. Additionally, Nephros expects to submit data to the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for clearance in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. in the 2nd half of 2004. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the National Institutes of Health, there were approximately 340,000 ESRD patients in the US in 2002, with more than 1 million patients worldwide. The net growth rate for ESRD is estimated at 7-9 percent per year. HDF is viewed as the most innovative treatment available for ESRD because it combines the diffusion process Diffusion process A conception of the way a stock's price changes that assumes that the price takes on all intermediate values. of hemodialysis with the convection process of hemofiltration to eliminate waste products and excess water. In earlier studies, patients on HDF have experienced improvements in blood pressure and anemia, as much as a 40 percent reduction in carpal tunnel syndrome carpal tunnel syndrome: see repetitive stress injury. carpal tunnel syndrome (CTS) Painful condition caused by repetitive stress to the wrist over time. surgeries (a marker for morbidity) and as much as a 10 percent mortality reduction versus a hemodialysis-based control group. The CE Marking for the OLpur(TM) MD 190 was supported by a clinical study performed under the supervision of Dr. Bernard Canaud and Dr. Detlef Krieter in Montpellier, France, evaluating the filter's safety and efficacy. Through the OLpur(TM) MD 190, Nephros has developed a proprietary mid-dilution HDF filter that provides higher filtration rates, superior small molecule clearance, and unsurpassed middle molecule clearance when compared to existing pre- or post-dilution HDF treatments, and offers a substantial improvement over conventional high flux hemodialysis in clearing uremic toxins. About Nephros, Inc. Nephros, Inc. has developed End Stage Renal Disease (ESRD) therapy products that dramatically improve clinical efficacy. Nephros has brought efficient mid-dilution diafiltration to the ESRD therapy domain with a unique and proprietary fluid management system offering optimized removal of renal toxins across the molecular spectrum. Nephros products also remove a range of harmful substances not effectively removed by existing dialysis methods; addressed specifically are substances that are part of a group known as middle molecules, due to their molecular weight, that contribute to such conditions as carpal tunnel syndrome, dialysis related amyloidosis Amyloidosis Definition Amyloidosis is a progressive, incurable, metabolic disease characterized by abnormal deposits of protein in one or more organs or body systems. , and degenerative bone disease in the ESRD patient. For more information, please visit the Company's website at www.nephros.com. |
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