Full Press Release Details
Receives Formal Response from FDA for 510(k) Application for Hemodiafiltration
EDGE, N.J., July 7, 2010 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin
Board:NEPH - News), a medical device company developing and marketing filtration
products for therapeutic applications, infection control, and water
purification, today reported that the U.S. Food and Drug Administration has
issued a formal response to the company's 510(k) application.
30, Nephros received a final decision letter from the FDA for the company's
510(k) submission which stated that the FDA could not reach a substantial
equivalence determination for the company's hemodiafiltration (HDF)
disappointed both by the FDA's decision to reject our application and by the
fact that the company was not provided an opportunity to address the current
comments prior to a final decision being rendered," said Paul A. Mieyal, acting
CEO of Nephros. "After more than 15 months without a substantive
communication, the company expected either an approval or further dialogue as
the next step in the process. We feel that the issues raised in the
current letter are addressable and have requested an in-person meeting with the
review team to discuss options for moving forward."
of the United States, hemodiafiltration is widely regarded by nephrologists as
the gold standard therapy for dialysis patients. We are disappointed
that the availability of HDF therapy in the U.S. has been further delayed,"
commented Lawrence J. Centella, a member of Nephros's Board of Directors and
former Chief Operating Officer of Gambro Healthcare, Inc.
has requested an in-person meeting to discuss the issues raised in the current
FDA letter as well as the process for moving forward.
upon the in-person meeting with the FDA reviewers, the company will determine
the appropriate course of action, which could include filing a new 510(k) application or filing an appeal related to the current application.
has engaged King & Spalding LLP as regulatory counsel to advise the company
in its next interactions with the FDA. The company also intends to
utilize the FDA's Ombudsman process.
current decision by the U.S. FDA with regard to Nephros's HDF system does not
impact the ability of the company to market and sell its mid-dilution (MD)
filters for hemodiafiltration procedures outside of the U.S.
Nephros dual stage ultrafilter (DSU) received 510(k) marketing clearance from
the FDA in 2009 to be used to filter biological contaminants from water and
bicarbonate concentrate used in hemodialysis procedures. The 510(k)
approval for the DSU filters is unrelated to the 510(k) application for the
company's HDF system.
continues to work with STERIS Corporation under the development agreement
executed in March 2010.
is continuing the development of its dual stage ultra reliable personal water
filtration system under support from its U.S. Department of Defense
Inc., headquartered in River Edge, New Jersey, is a medical device company
developing and marketing filtration products for therapeutic applications,
infection control, and water purification.
Nephros hemodiafiltration (HDF) system is designed to improve the quality of
life for the End-Stage Renal Disease (ESRD) patient while addressing the
critical financial and clinical needs of the care provider. ESRD is a disease
state characterized by the irreversible loss of kidney function. The Nephros HDF
system removes a range of harmful substances more effectively, and with greater
capacity, than existing ESRD treatment methods, particularly with respect to
substances known collectively as "middle molecules." These molecules have been
found to contribute to such conditions as dialysis-related amyloidosis, carpal
tunnel syndrome, degenerative bone disease and, ultimately, mortality in the
ESRD patient. Nephros ESRD products are sold and distributed throughout
Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water
filtration products. The patented dual stage cold sterilization ultrafilter has
the capability to filter out bacteria and, due to its exceptional filtration
levels, filter out many viruses, parasites and biotoxins. Nephros's DSUs are
being evaluated at several major U.S. medical centers for infection control. The
DSU has also been selected for further development by the U.S. Marine Corps for
purification of drinking water by soldiers in the field.
information about Nephros, please visit our website at
in this news release that are not historical facts constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995 (the "PSLRA"). Such statements may be preceded by words such as "may,"
"plans," "expects," "believes," "hopes," "potential" or similar words. For such
statements, Nephros claims the protection of the PSLRA.
statements are not guarantees of future performance, are based on assumptions
and are subject to various known and unknown risks and uncertainties, many of
which are beyond Nephros' control. Actual results may differ materially from the
expectations contained in the forward-looking statements. Factors that may cause
such differences include the risks that Nephros may not be able: (i) to obtain
appropriate or necessary governmental approvals to achieve its business plan or
effectively market its products; (ii) to obtain additional funding when needed
or on favorable terms; (iii) to continue as a going concern; (iv) to have its
technologies and products accepted in current or future target markets; (v) to
demonstrate in pre-clinical or clinical trials the anticipated efficacy, safety
or cost savings of products that appeared promising to Nephros in research or
clinical trials; or (vi) to secure or enforce adequate legal protection,
including patent protection, for its products. More detailed information about
Nephros and the risk factors that may affect the realization of forward-looking
statements is set forth in Nephros' filings with the SEC. Investors
and security holders are encouraged to read these documents on the SEC's website
at http://www.sec.gov/. Nephros does not undertake to publicly update or revise
its forward-looking statements as a result of new information, future events or
otherwise except as required by law.