Nephros Eyes Larger Markets

Nephros Inc. (OTC Bulletin Board: NEPH) has been busy lately. First, it arranged for global marketing of ultrafiltration (UF) technology products under an agreement made April 23 with an Italian firm, Medical S.p.A.

On April 30, Nephros announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its hemodiafiltration (HDF) system for the treatment of chronic renal failure when used with UF-controlled dialysis machines that provide ultrapure dialysate. The company noted that the system is in accordance with current standards of the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute, and the International Organization for Standardization in the United States.

The company’s latest 510(k) clearance is for a system comprising a hemodiafilter and a hemodiafiltration module, Nephros’s OLpur MD220 Hemodiafilter and Nephros’s OLpur H2H Hemodiafiltration module, which are designed to work together.

“Nephros can now offer the only on-line HDF therapy available in the U.S.,” said John C. Houghton, who was appointed president and chief executive officer of Nephros, Inc., on April 20, 2012. “Nephros will first pursue a limited launch of its HDF system before expanding into the broader market. In parallel, Nephros will evaluate opportunities to leverage the resources of a strategic partner to most effectively address the market.”

Houghton most recently served as president and chief executive officer of CorMedix Inc., a pharmaceutical company focused on therapeutic products for the treatment of cardiorenal disease.

In 2011, Nephros positioned itself for its new efforts by completing $3.2 million in financing and raising ultrafiltration product revenues to approximately $618,000, an increase of 24 percent from the year before.

Two years earlier, Nephros marketed its first FDA-cleared product, Dual Stage Ultrafilters (DSU) for in-line purification of dialysate water and bicarbonate solution for hemodialysis.

The AAMI had adopted more stringent water purity standards for dialysis applications. Nephros noted that the new AAMI standards combined with “significant observational studies showing a substantial reduction in required erythropoietin” dosing when the Nephros DSU is used in dialysis accounted for increased interest in Nephros ultrafiltration products recently, according to

June 2012 (Vol. 4, Number 6)