Nephros Receives FDA 510(k) Clearance of EndoPurTM Endotoxin 10” Filter
Launch Expected in Second Quarter of 2017
RIVER EDGE, NJ, March 6, 2017 /MarketWired/ — Nephros, Inc. (OTCQB:NEPH) (the “Company”), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration (“HDF”) system for use with a hemodialysis machine for the treatment of patients with end stage renal disease, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its EndoPurTM Endotoxin 10” Filter.
The EndoPurTM Endotoxin 10” Filter is designed to provide hemodialysis quality water to dialysis machines. This new product fits into existing filter cartridge housings of the reverse osmosis (“RO”) water systems that provide dialysis clinics with high volumes of ultrapure water. The EndoPurTM offers dialysis clinics an endotoxin barrier with the smallest pore size on the market.
“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, both large clinic-based and small portable. We expect to begin selling the EndoPur to customers in the second quarter of 2017.”
About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters, as well as a hemodiafiltration system for the treatment of patients with end stage renal disease. Its filters, which it calls ultrafilters, are used primarily in medical applications. Nephros ultrafilters are used by dialysis centers for the removal of biological contaminants from the water and bicarbonate concentrate feeding hemodialysis devices. Additionally, Nephros ultrafilters are used in hospitals and medical clinics as an aid in infection control by retaining bacteria (e.g., Legionella, Pseudomonas), virus and endotoxin from water used by patients.
For more information about Nephros, please visit the company’s website at www.nephros.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the EndoPur Endotoxin 10” Filter, including its potential to provide hemodialysis quality water and the expected timing of our first customer sales, are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Nephros Inc.’s reports filed with the U.S. Securities and Exchange Commission, including with respect to Nephros, its Annual Report on Form 10-K for the year ended December 31, 2015. Nephros, Inc. does not undertake any responsibility to update the forward-looking statements in this release.
PCG Advisory Group
Kirin M. Smith, Chief Operating Officer