Nephros Launches SSUmini and Provides S100 Update
RIVER EDGE, NJ, March 16, 2016 /Businesswire/ — 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, announces the release of the SSUmini, a smaller version of its SSU-D medical device.
The SSUmini was developed as a compact, economical solution to provide hemodialysis quality water as a polish filter for smaller, portable reverse osmosis (“RO”) systems and to provide hemodialysis quality bicarbonate concentrate for dialysis clinics with centralized bicarbonate systems. For low-flow rate situations, the SSUmini can provide protection from bacteria, viruses and endotoxins for up to 12 months. The SSUmini is a medical device with U.S. Food and Drug Administration (“FDA”) 510(k) clearance. Details on the SSUmini can be found at www.nephros.com/dialysis.
“We have been working with multiple dialysis water system suppliers and have identified an area where we believe our filter technology could add additional value,” said Monet Carnahan, Director of Dialysis Products at Nephros. “The SSUmini is small enough to fit inside most portable RO systems, enabling our partners to supply the product as an OEM part. It also provides a low-cost, long-life polish filter for those dialysis clinics that centrally mix their bicarbonate concentrate.”
The SSU-10 is also now available. The SSU-10 is ideal as a polish filter for smaller RO systems, either on the laboratory benchtop or in the home setting under the sink. The SSU-10 is not a medical device.
S100 510(k) Update
The Company filed for 510(k) clearance for its S100 Point of Use microfilter with the FDA in late October 2015. In late December 2015, the FDA requested additional information. On March 8, 2016, the Company submitted a package to the FDA with supplemental information. Pending FDA clearance, the Company aims to launch the S100 in the second quarter of 2016.
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 timing of the Company’s responses to the FDA relating to its 510(k) submission for its S100 product; feedback from customers regarding our new products; the timing of planned deliveries of products to the Company’s distributors and partners; our plans to expand our product line, our expectations related to the receipt of FDA clearance on new products; our plan to expand into additional market segments; our plan to grow revenues sufficient to generate positive cash flow, 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, uncertainties in the FDA clearance process, the acceptance of our product offerings by customers and end users, and the availability of sufficient capital to fund our operating activities. 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.
PCG Advisory Group
Kirin M. Smith, Chief Operating Officer