Nephros Receives FDA 510(k) Clearance of HydraGuardTM 10” UltraFilter
Expands Hospital Infection Control Product Line
RIVER EDGE, NJ, December 27, 2016 /PR Newswire-FirstCall/ — 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 that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its HydraGuardTM 10” UltraFilter.
The HydraGuardTM 10” UltraFilter is designed to provide hospitals and medical facilities with a long term solution to protect patients from bacteria that may be present in the potable water systems. Legionella and pseudomonas are common bacteria that can have a devastating impact on patients whose immune systems are compromised. The HydraGuardTM 10” UltraFilter cartridge is used with a durable 10” filter housing and provides up to 6 months of life for equipment such as ice machines, endoscope re-processors and surgical humidifiers.
“The HydraGuard is a powerful addition to our infection control portfolio, with the potential to significantly aid our customers in their constant battle against Legionella and other water borne pathogens,” said Daron Evans, President and CEO of Nephros. “With its 5 nanometer protection, its six month life, and its low annual cost versus competitive products, we believe the HydraGuard will set a new standard in performance and customer expectations.”
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 HydraGuard 10” UltraFilter, including its potential to significantly aid in reducing infection from water borne pathogens 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. 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