Full Press Release Details
Provides Corporate Update
NY--(PR NEWSWIRE)--November 20, 2008 -- Nephros, Inc. (AMEX:NEP - News), a
medical device company developing and marketing filtration products for
therapeutic applications, infection control, and water purification, today
provided an update on its operations and strategy.
Highlights and Events
has undergone major changes in its management structure and operational
activities this year. We felt it was important to provide shareholders an
overview of these changes and of our strategy for the future," said Ernest A.
Elgin, President and CEO of Nephros.
MD220 Dialyzers and H2H Hemodiafiltration Module
has submitted a 510k application to the FDA for approval to market its
leading-edge hemodiafiltration ("HDF") products for end-stage renal disease
(ESRD) in the U.S. The application details Nephros's OLpur MD220 diafilter and
Nephros's OLpur H2H Hemodiafiltration module. Nephros's OLpur MD220 is a filter
designed expressly for HDF therapy that employs Nephros's proprietary
Mid-Dilution Diafiltration technology. Nephros's OLpur H2H Hemodiafiltration
module enables the most common types of dialysis machines to be used for HDF
therapy. Nephros believes that, if approved in 2009, its technology would be
first approved on-line HDF therapy available in the U.S.
OLpur MD220 diafilters are currently approved in the European Union and Canada.
Net diafilter revenues for the nine months ended September 30, 2008 were
$920,000 compared to $755,000 in the corresponding period of 2007, an increase
of approximately $165,000 or 22%. The increase is due to increased sales of
OLpur MD190 and MD220 diafilters in Europe.
interest in the Nephros ESRD products continues to be strong; the 510k
submission for FDA approval of Nephros's products represents an important
milestone toward bringing HDF therapy to the U.S.," said Eric A. Rose, M.D., a
member of Nephros's Board of Directors.
has filed a 510k application for approval to market its Dual Stage Ultrafilters
(DSU) to dialysis clinics. "We are seeing a great interest for ultra pure water
in dialysis centers for water polishing applications," said Mr.
is developing improvements to the functionality of its water ultrafiltration
products and has applied for water filter performance certifications from NSF
International, an independent non-profit product evaluation laboratory. Nephros
currently anticipates completion of required NSF testing in early
third quarter, Nephros recorded initial revenues of $9,000 from the sale of
water filtration products in the U.S. Nephros expects DSU sales to represent
increasing percentage of Nephros's revenue mix going forward.
has launched two new products aimed at preventing the risk of water borne
diseases at the point of use. The Nephros Protect! Kit, for showers and sinks,
and the Nephros Prevent! Kit, for in-line applications such as ice machines
clinical equipment, provide immediate risk mitigation. There have been multiple
reported outbreaks and deaths due to Legionnaire's disease this year in
institutional facilities in the U.S. Legionnaire's disease is caused by a
bacterium known as legionella pneumophila. Legionella can live in water and
often found in the plumbing systems of buildings such as hospitals, nursing
personal care facilities, ambulatory facilities and medical and dental
practices. In cases where the levels of these pathogens may not pose much threat
to healthy water users, immuno-compromised patients such as cancer, cystic
fibrosis, HIV, organ transplant, and burn patients may have a substantial risk
of infection. Nephros's DSU filtration products are an effective solution which
can provide immediate safety from water borne pathogens including
has contracted with the Office of Naval Research to develop an advanced water
purification system for military field use. Nephros's proprietary dual stage
cold sterilization ultrafilter will form the basis of the portable system.
Nephros is continuing the development of its dual stage ultra reliable personal
water filtration system under support from its U.S. Department of Defense (DoD)
appropriation and has completed initial concept development. Initial prototypes
are anticipated to be completed in the first half of 2009. With the additional
appropriation from the DoD, Nephros will expand the program and plans to
conclude development and to conduct limited field testing in 2009. Nephros
generated approximately $50,000 of revenue in the third quarter of 2008 and
$103,000 of revenue during the nine months ended September 30, 2008 from its
U.S. Defense Department project.
has initiated actions to aggressively reduce operating expenses and preserve
cash resources. Nephros has reduced its R&D staff to reflect the completion
of its U.S. clinical trial and submission of the 510k application for the
associated products.
taken difficult, but necessary actions, to reduce fixed costs and redirect
valuable cash resources to our revenue generating efforts. We appreciate the
dedication and past efforts of those employees affected by this transition
thank them for their contributions," said Mr. Elgin.
Nephros has signed a lease for a new, less costly location in River Edge, NJ.
Nephros has applied, and has been approved, for a grant from New Jersey's
Business Employment Incentive Program (BEIP). The BEIP is an incentive grant
from the State of New Jersey's Business Development Agency to help offset
overhead expenses to attract companies to move to New Jersey. As a result of
this program, Nephros will receive annual cash grants based on the number of
jobs it moves to New Jersey and all new jobs created by Nephros in the State
New Jersey for a ten year period. Nephros's relocation is anticipated to be
completed by year-end.
combined benefits of the reduction in headcount and the relocation of Nephros's
offices will significantly reduce Nephros's fixed expenses going
for Fourth Quarter and 2009
remainder of 2008, Nephros plans to focus its efforts on commercialization
activities. Primary goals for Nephros in 2009 include expansion of DSU product
sales for institutional infection control and preparation for the anticipated
launch of Nephros's OLpur MD 220 Hemodiafilter, OLpur H2H Hemodiafiltration
Module, and DSU products for dialysis centers in the U.S.
immediate future, we are taking steps to increase our DSU marketing efforts
sales to hospitals, assisted living facilities, and related domains in the
and abroad," said Mr. Elgin. "To that end, we will seek to expand our
distribution network and leverage strategic relationship opportunities to
generate greater access to these markets."
Board of Directors applauds Mr. Elgin's efforts to reduce costs and maximize
value for Nephros shareholders. We believe that the aggressive changes that
Nephros's new CEO has implemented will help position Nephros for long-term
success," said James S. Scibetta, Chairman of Nephros.
Inc., headquartered in New York, is a medical device company developing and