Nephros, Inc. (NEPH: OTCQB) | Nephros Clarifies the Status of Evaluation of its Hemodiafiltration System


Nephros Clarifies the Status of Evaluation of its Hemodiafiltration System

Feb 13, 2015

OTC Disclosure News Service

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
use with a hemodialysis machine for the treatment of chronic renal
failure patients, today provided an update on the status of an
evaluation of its on-line mid-dilution hemodiafiltration system.

As previously announced, DaVita Kidney Care, a division of DaVita
HealthCare Partners Inc., initiated a product evaluation of the Nephros
hemodiafiltration system. In the course of the evaluation, DaVita
informed Nephros that they would require additional validation of the
system. Nephros and DaVita agreed upon a protocol for the additional
validation work which is projected to be completed in approximately 4-6
weeks. Upon satisfactory completion of the additional validation work,
it is anticipated that DaVita will continue its evaluation. The details
of DaVita’s product evaluation remain confidential.

To clarify a comment made by DaVita’s VP of Investor Relations, Jim
Gustafson, Shaun Collard, VP of Clinical Operations for DaVita noted
that “It was incorrect to say that the hemodiafiltration evaluation at
DaVita was stopped because we did not see it as promising. It was
interrupted for technical reasons, and Nephros and DaVita are working to
address those issues with the intent that the evaluation can resume.”

“DaVita is a leading dialysis provider, and Nephros has had a
long-standing interaction with the company,” stated Dr. Paul Mieyal,
acting CEO of Nephros. “The Nephros H2H system is the only FDA-cleared
hemodiafiltration system available in the U.S., and we value the
feedback from DaVita’s product evaluation. Nephros continues to explore
all opportunities to make this important therapy broadly available to
patients in this country, and evaluations like DaVita’s are helping us
to define our best path forward.”

About Nephros, Inc.

Nephros is a commercial stage medical device company that develops and
sells high performance liquid purification filters. Our filters, which
we call ultrafilters, are primarily used in dialysis centers for the
removal of biological contaminants from water, bicarbonate concentrate
and/or blood.

We were founded in 1997 by healthcare professionals affiliated with
Columbia University Medical Center/New York-Presbyterian Hospital to
develop and commercialize an alternative method to hemodialysis (HD). We
have extended our filtration technologies to meet the demand for liquid
purification in other areas, in particular water purification.

Presently, we offer ultrafilters for sale to customers in five markets:

  • Dialysis Centers – Water/Bicarbonate: Filtration of water or
    bicarbonate concentrate used in hemodialysis devices
  • Dialysis Centers – Blood: Treatment of patients with chronic
    renal failure using the OLPūr H2H Hemodiafiltration (“HDF”) Module in
    conjunction with a UF controlled hemodialysis machine and its
    accessories, the H2H Module accessories, appropriately prepared water
    and ultrapure dialysate for hemodialysis and the OLPūr MD 220
  • Hospitals and Other Healthcare Facilities: Filtration of water
    to be used for patient washing and drinking as an aid in infection
    control. The filters also produce water that is suitable for wound
    cleansing, cleaning of equipment used in medical procedures and
    washing of surgeon’s hands
  • Military and Outdoor Recreation: Highly compact, individual
    water purification devices used by soldiers and backpackers to produce
    drinking water in the field
  • Commercial Facilities: Filtration of water for washing and
    drinking including use in ice machines and soda fountains

For more information about Nephros, please visit the company’s website

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking
statements.” Such statements include statements regarding the
expectation that DaVita will continue to evaluate our on-line
mid-dilution hemodiafiltration system and the expected timeline for
doing so, the efficacy and intended use of our technologies under
development, the timelines for bringing such products to market and the
availability of funding sources for continued development of such
products 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.
Forward-looking statements are not guarantees of future performance, are
based on certain assumptions and are subject to various known and
unknown risks and uncertainties, many of which are beyond our control.
Actual results may differ materially from the expectations contained in
the forward-looking statements. Factors that may cause such differences
include, but are not limited to, the risks that: (i) we may not be able
to continue as a going concern; (ii) we may not be able to obtain
funding if and when needed or on terms favorable to us in order to
continue operations and successfully implement our business plan; (iii)
we face significant challenges in obtaining market acceptance of our
products and sales growth in key geographic areas, which could adversely
affect our potential sales and revenues; (iv) a default under the terms
of the secured note with Lambda Investors LLC would result in the lender
foreclosing upon substantially all of our assets and could result in our
inability to continue business operations and restrictions in the
secured note and related security agreement may restrict our ability to
operate our business, sell the company or sell our assets;; (v) we face
potential liability associated with the production, marketing and sale
of our products including with respect to potential serious injuries,
product-related deaths or product malfunctions, product recalls, product
liability claims, class action lawsuits or other events that could cause
us to incur expenses and may also limit our ability to generate revenues
from such products; (vi) to the extent our products or marketing
materials are found to violate any provisions of the FDC Act or any
other statutes or regulations then we could be subject to enforcement
actions by the FDA or other governmental agencies; (vii) the voluntary
recalls of point of use and DSU in-line ultrafilters used in hospital
water treatment applications announced on October 30, 2013 and the
related circumstances could subject us to claims or proceedings by
consumers, the FDA or other regulatory authorities which may adversely
impact our sales and revenues; (viii) we may encounter problems with our
suppliers, manufacturers and distributors; (ix) we may encounter
unanticipated internal control deficiencies or weaknesses or ineffective
disclosure controls and procedures; and (x) we may not be able to secure
or enforce adequate legal protection, including patent protection, for
our products.

More detailed information about us and the risk factors that may affect
the realization of forward-looking statements, including the
forward-looking statements contained in this press release, is set forth
in our filings with the SEC, including our Annual Report on Form 10-K
for the fiscal year ended December 31, 2013, and our other periodic
reports filed with the SEC. We urge investors and security holders to
read those documents free of charge at the SEC’s website at
We do not undertake to publicly update or revise our forward-looking
statements as a result of new information, future events or otherwise,
except as required by law.

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