FDA APPROVES NEPHROS' OLPUR HD190 HIGH FLUX FILTER

The FDA gave 510(k) clearance to Nephros for its OLpur HD190 high flux filter, designed for use in a variety of end-stage renal disease (ESRD) therapies, including hemodialysis (HD) and hemodiafiltration (HDF).

"This approval marks the beginning of our move into the U.S, and we believe this approval should also simplify and accelerate the 510(k) approval process for our MD190 and H2H products," said Nephros CEO Norman Barta.

Although the OLpur HD190 is not expected to offer a substantial sales opportunity in the foreseeable future, Nephros believes the approval of the OLpur HD190 is an important step in the regulatory process to gain approval for its more advanced ESRD therapies in the U.S. Nephros plans to seek FDA approval of its OLpur MD190 and OLpur H2H -- an add-on module that converts the most common types of hemodialysis machines into HDF-capable machines -- and to introduce both products in the U.S. simultaneously.