Nephros, Inc. announced that on August 11, 2011 they filed a 510(k) application with the Food and Drug Administration (FDA) for clearance of their hemodiafiltration system. Nephros is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification. Nephros, Inc. has their headquarters in River Edge, New Jersey.
Dr. Paul Mieyal, acting CEO of Nephros, Inc., said, “Nephros is pleased to have filed this new application for clearance of its hemodiafiltration system. We thank King & Spalding for the firm’s counsel during the process, and we look forward to the FDA’s review of the new application.”
On August 11, 2011, Nephros submitted a new 510(k) application to market their hemodiafiltration (HDF) system for end-stage renal disease. Upon issuance of a 510(k) application tracking number, the application will be subject to the FDA’s standard 90-day review period. The application details the Company’s OLpur MD220 diafilter and their OLpur H2H Hemodiafiltration module. Their OLpur MD220 is a dialyzer designed expressly for HDF therapy that employs the Company’s proprietary Mid-Dilution diafiltration technology. The design of their OLpur H2H Hemodiafiltration module is to enable the most common types of standard dialysis machines to perform HDF therapy. Nephros believes that, if approved, their technology would be the first approved online HDF therapy available in the United States.
The design of the Nephros hemodiafiltration (HDF) system is to improve the quality of life for the End-Stage Renal Disease (ESRD) patient. This is while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods. This is particularly with respect to substances known collectively as “middle molecules.” These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient.
The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products. This includes the MSU and SSU ultrafilters. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria. Due to its exceptional filtration levels, it also has the capability to filter out many viruses, parasites and biotoxins. The Nephros DSU, MSU, and SSU are FDA cleared for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. The Company’s DSU ultrafilters are undergoing evaluation at several major U.S. medical centers for infection control. Additionally, Nephros ultrafilter technology has been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.
For more information visit: www.nephros.com
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