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Nephros Announces FDA 510(k) Submission of S100 Ultrafilter

RIVER EDGE, NJ, October 27, 2015 /Businesswire/ — Nephros, Inc. (OTCQB:NEPH), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration system for the treatment of chronic renal failure patients, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) for 510(k) clearance, the S100 Point of Use filter designed to filter Environmental Protection Agency (EPA) quality drinking water to retain waterborne bacteria to assist in infection control.

The S100 ultrafilter is designed to assist hospitals and medical facilities with temporary protection from bacteria that may be dispersed into the water from biofilm growing in a building’s piping infrastructure. Legionella and pseudomonas are common bacteria that can have a devastating impact on patients whose immune systems are compromised. The S100 Point of Use filter attaches to the end of a sink faucet and was designed and tested to provide 3 months of protection.

“During a water borne pathogen outbreak, it is vital that medical professionals have the ability to quickly contain the bacteria and provide for patient safety while the building engineers and water treatment professionals undertake the arduous task of cleaning the building’s piping,” said Daron Evans, President and CEO of Nephros. “Subject to FDA clearance, the S100 will add another product to our infection control portfolio targeted at providing bacteria free water for patient washing and drinking.”

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 kidney 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 concentratefeeding 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.

Forward-Looking Statements

This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding whether the FDA will grant 510(k) clearance of the S100filter, the effectiveness of the S100 filter to retain waterborne bacteria and aid in infection control, 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 changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. In particular, there can be no assurance that the S100 filter will receive FDA clearance. 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, 2014. Nephros, Inc. does not undertake any responsibility to update the forward-looking statements in this release.

Contact:

 

Investor:
PCG Advisory Group
Kirin M. Smith, Chief Operating Officer
Direct: 646-863-6519
www.pcgadvisory.com
 
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