Full Press Release Details
Reports Preliminary 2015 Revenue and Provides Update
EDGE, NJ, February 1, 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, reports
preliminary top-line revenue for the fiscal year 2015 and provides business update.
(unaudited) 2015 Revenue
product revenue for the year ended December 31, 2015 is estimated to be approximately $1.8 million versus approximately $0.9 million
for the year ended December 31, 2014. Net licensing and royalty revenue for the year ended December 31, 2015 is estimated to be
approximately $150 thousand versus approximately $800 thousand for the year ended December 31, 2014.
Company filed for 510(k) clearance for its S100 Point of Use microfilter with the U.S. Food and Drug Administration (FDA) in late
October 2015. In late December 2015, the FDA requested additional information. The Company is currently performing the additional
testing and expects to be able to provide the needed supplemental information to the FDA in February 2016. Pending FDA clearance,
the Company aims to launch the S100 in the second quarter of 2016.
Filter Cartridge Update
Company intends to file for 510(k) clearance of its endotoxin cartridge filter in March 2016. The endotoxin cartridge filter is
designed to provide hemodialysis quality water through ultrafiltration of the water in a dialysis clinic's reverse osmosis
("RO") loop. Because the cartridge conforms to the design controls of the DSU-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 in the second quarter of 2016.
New Filtration Products
Bacterial Filter: By March 2016, the Company intends to deliver the first lot of bacterial filter cartridges to Biocon 1, LLC
for inclusion in its AETHER Water System product offering targeting the food service industry.
In March 2016, the Company intends to launch the SSUmini, a smaller version of the SSU-D, designed to provide hemodialysis quality
water as a polish filter for small, portable RO systems and to provide hemodialysis quality bicarbonate concentrate for dialysis
clinics with centralized bicarbonate systems.
Filter Cartridge, Large System: Over the last few years, the Company has been developing a high-throughput, auto-flushing filter
system capable of handling 25 gallons per minute ("GPM"), or greater, through the Company's proprietary 5 nanometer
fiber membrane. The flushable filter system is designed to remove submicron particulates in closed loop water systems, including
cooling systems for data centers and hot water return loops in commercial buildings. Initial data suggests the ability to remove
both organic and inorganic particulates. The Company intends to provide limited release of a 25 GPM system to specific customers
for additional testing and validation by the third quarter of 2016.
Filter Cartridge, Small System: In 2016, the Company intends to develop flushable filter cartridges capable to filtering 2.5,
5 and 10 GPM through the Company's proprietary 5 nanometer fiber membrane. The smaller flushable filter systems have potential
utility as a point-of-entry water purification system in restaurants, convenience stores and households. The Company intends to
provide limited release through its strategic partnership with Biocon 1, LLC in the second half of 2016.
January 2016, the Company finalized and implemented a software update to its OLp r H2H Hemodiafiltration System. The update
incorporated feedback from system users to improve the alignment of the system with standard work flows. Additionally, the Company
worked with system users to update the policies and procedures for the system, as well as the training modules for system user
the second quarter of 2016, the Company aims to launch HDF treatment at a major academic institution to begin the process of developing
observational data on the HDF experience in the US dialysis clinic setting.
continue to make progress toward our operational goals on our path to being cash flow positive by the end of this year,"
said Daron Evans, President and Chief Executive Officer of Nephros. "Our expanded ultrafilter portfolio in combination with
our strengthening distributor partnerships in the hospital, dialysis and food service industries positions us well to accelerate
our revenue growth in 2016 and beyond. We also look forward to CamelBak's release of the Microbiological Advanced Purification
System, which includes technology licensed from Nephros, later this year."
progress on the HDF system is particularly exciting. This year we hope to shift the focus from operational observation to clinical
observation, which could help further educate patients and nephrologists in the U.S. about the benefits of HDF therapy."
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.
more information about Nephros, please visit the company's website at www.nephros.com.
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; the timing
of the commercial launch of the Company's S100, endotoxin cartridge filter, and SSUmini products; the timing of the limited
release of the Company's 25 GPM auto-flushing filter and small system flushable filter cartridge products; feedback from
customers regarding our new products; the timing of the planned 510(k) submission for the Company's endotoxin cartridge
filter product; the timing of planned deliveries of products to the Company's distributors and partners; the timing of adding
additional sites to test the Company's HDF treatment; our expected financial and operational performance, including sales
momentum, in future financial periods; 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.
M. Smith, Chief Operating Officer