Nephros’ New Filter Approved

The US Food and Drug Administration (FDA) has approved a new filter from Nephros (River Edge, NJ).

In early March 2017, Nephros received 510(k) clearance to market its EndoPur™ Endotoxin 10-Inch Filter.

The filter is designed to provide hemodialysis-quality water to dialysis machines. It fits into existing filter cartridge housings of the reverse osmosis (RO) water systems that provide dialysis clinics with high volumes of ultrapure water. The EndoPur™ has an endotoxin barrier with the smallest pore size on the market, the company announced.

“With the FDA clearance of the EndoPur, we have achieved a significant milestone in the expansion of our dialysis water filter portfolio,” said Daron Evans, president and CEO of Nephros. “We now can provide our industry-leading 5-nanometer pore-size endotoxin protection to all dialysis clinic RO systems. We expect to begin selling the EndoPur to customers in the second quarter of 2017.”

The filter can be used in large clinic-based, and small, portable machine scenarios.

Nephros’ primary objectives in the second half of 2016 were to support the commercial launch of the S100 Point-of-Use filters and to complete the regulatory process for the 10-inch filter platform. The company also focused efforts on launching its hemodiafiltration treatment at a dialysis clinic managed by Vanderbilt University, according to a corporate update announcement.

Nephros expected total revenue for fourth quarter 2016 to exceed $740,000 and predicts it will be cash flow positive by the end of the second quarter of 2017, as its 10-inch cartridge product line becomes available. Nephros ultrafilters are used by dialysis centers to assist in the added removal of biological contaminants from water and bicarbonate concentrate in hemodialysis machines.

April 2017 (Vol 9, Number 4)