Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today announced that on August 11, 2011 it filed a 510(k) application with the Food and Drug Administration (FDA) for clearance of its hemodiafiltration system.
On August 11, 2011 Nephros submitted a new 510(k) application to market its 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 Nephros's OLpur MD220 diafilter and Nephros's OLpur H2H Hemodiafiltration module. Nephros's OLpur MD220 is a dialyzer designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution diafiltration technology. Nephros's OLpur H2H Hemodiafiltration module is designed to enable the most common types of standard dialysis machines to perform HDF therapy. Nephros believes that, if approved, its technology would be the first approved on-line HDF therapy available in the U.S.
"Nephros is pleased to have filed this new application for clearance of its hemodiafiltration system," said Dr. Paul Mieyal, acting CEO of Nephros. "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."