RIVER EDGE, NJ, April 21, 2016 /Issuer Direct / — 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, announced today that it has submitted a Special 510(k) application to the U.S. Food and Drug Administration (FDA) for its EndoPurTM ultrafilter designed to provide hemodialysis quality water.
The EndoPurTM ultrafilter cartridge is intended to be used as an endotoxin filter in a dialysis clinic’s reverse osmosis loop to provide ultrapure water for use in hemodialysis machines. The EndoPurTM will be offered in 10”, 20”, 30” and 40” sizes to best meet the broad needs of dialysis water treatment specialists who help maintain the water systems designed to meet the strict water quality standards required for the treatment of patients with end stage renal disease.
Because the cartridge conforms to the design controls of the SSU-D, and has the same intended use, the cartridge qualifies for the Special 510(k): Device Modification process, which has a 30 day FDA review timeline. Pending FDA clearance, the Company aims to launch the filter near the end of the second quarter of 2016.
“When approved, the EndoPur ultrafilter will round out our ultrafilter portfolio that supports dialysis clinics’ efforts to provide their patients with the highest possible level of water purity,” said Daron Evans, President and CEO of Nephros. “We look forward to working with our distributors to position the EndoPur for success in the market.”
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 (i.e. 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 EndoPurTM, including its eligibility for Special 510(k) clearance, the timing of its commercial launch, and other statements that 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 potential delays in the regulatory approval process, changes in business, economic and competitive conditions, the availability of capital when needed, our dependence on third party manufacturers, regulatory reforms, 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