Full Press Release Details
Receives Conditional Approval
the FDA of Investigational Device
Technologies Targeted to Begin Clinical Trials in First Quarter
NY--January 29, 2007 -- Nephros, Inc. (AMEX:NEP)
reported that the Company received conditional approval for its Investigational
Device Exemption (IDE) application from the Food and Drug Administration (FDA)
to begin a human clinical trial of the Company's
Hemodiafiltration Module and
Hemodiafilter. Nephros has been granted this approval on the condition that,
March 5, 2007, it will submit a response to two informational questions from
FDA. The Company has already provided a partial response to these
is also required to obtain approval from one or more Institutional Review Boards
(IRBs) in order to proceed with its clinical trial. Nephros is in the process
seeking approvals from the relevant IRBs.
plans to conduct the trial at three clinics in the Greater New York area:
University Dialysis Center (Dr. Anthony Valeri, M.D., Associate Professor of
Clinical Medicine, Columbia University, College of Physicians & Surgeons,
NY, site principal investigator);
Dialysis Center (Dr. Robert Lynn, M.D., Clinical Associate Professor of
Medicine, Albert Einstein College of Medicine, site principal investigator);
North Brunswick, New Jersey (Dr. Toros Kapoian M.D., FACP, Associate Professor
of Medicine, Robert Wood Johnson Medical School, site principal
University Dialysis Center and Bronx Dialysis Center are affiliated with or
managed by DaVita, Inc. and DCI is affiliated with or managed by Dialysis
Leonard Stern, M.D., FACP, FASN, who is an Associate Professor of Clinical
Medicine at Columbia University, College of Physicians & Surgeons in New
York, will act as Coordinating Principal Investigator during the trial.
and Dr. Stern anticipate that the introduction of online hemodiafiltration
into the clinical arena for dialysis-dependent patients will provide
improvement in dialysis care compared to conventional hemodialysis. They also
believe that this new treatment method offers the promise of improving the
quality of life for this chronically ill group, while reducing both morbidity
Kapoian from DCI stated, "Since the 1970's, we have not seen substantial
advances in the actual dialysis process here in the U.S. I believe this is
exciting opportunity to explore a new therapy for End-Stage Renal Disease
patients in the United States that may have a positive impact on patient care."
Barta, President and Chief Executive Officer of Nephros, commented, "This FDA
action is a critical step forward for Nephros, allowing us to proceed with
clinical trials on our MD and H2H
technologies. There is a growing body of evidence supporting the benefits of
hemodiafiltration therapy over hemodialysis therapy. Furthermore, studies in
Europe have demonstrated the superiority of Nephros' mid-dilution therapy over
existing hemodialysis and HDF therapies with respect to certain measures of
performance. We believe that, upon its approval, Nephros' technology will be a
vitally important addition to the physician's arsenal in treating patients with
End-Stage Renal Disease, providing potentially substantial reductions in patient
morbidity, mortality, and overall treatment costs."
Mid-Dilution Technology:
is an accepted therapy practiced widely in Europe, where HDF machines are
available. HDF is a convective-based renal replacement therapy, whereby a
negative pressure (similar to a vacuum effect) is applied to draw plasma water
and additional toxins from the blood as it passes by the hemodialyzer membrane.
In HDF, this convective process takes place at the same time that toxins are
removed by diffusion, which is the basis of hemodialysis, the renal replacement
therapy commonly practiced in the United States. By combining diffusion with
convection, HDF offers efficient removal of small solutes by diffusion, while
providing improved removal of larger substances (i.e., middle molecules) by
convection. Nephros has patented technology relating to a design and process
called Mid-Dilution Diafiltration, or MDF. MDF is a fluid management system
optimizes the removal of both small toxins and middle-molecules by offering
advantages of pre-dilution HDF and post-dilution HDF combined in a single
dialyzer cartridge. Nephros has
demonstrated through clinical trials in Europe that the MDF process provides
improved removal of certain toxins in HDF treatments, and believes this will
result in improved patient health and a concurrent reduction in healthcare
believes that its OLp r MDHDF filter series (including the OLp r MD220) are
the only filters designed specifically for HDF and offer superior toxin
clearance as well as improved performance over conventional
The Nephros OLp r MDHDF filter series, having received CE Marking in Europe, is
in clinical use in 12 European countries.
clinics a simple way to upgrade hemodialysis therapy to HDF therapy without
incurring the costs and
inconveniences generally associated with HDF machines. The OLp r H2H
add-on module that converts the most common types of hemodialysis machines
HDF-capable machines. As a result, clinics using the OLp r H2H
able to introduce patients to HDF therapy without replacing an existing dialysis
machine base or incurring large machine-replacement costs.
on the IDE approval, William Fox, Executive Chairman of Nephros, said,
"According to industry sources, the number of End-Stage
worldwide is expected to grow approximately 50% to 2.4 million by 2010. Our
blood filter, already being utilized in over 50 clinics in Europe, offers both
clinical and economic advantages over conventional dialysis treatment. Studies
of HDF therapy have shown reductions of up to 35% in mortality risk, substantial
drug reductions, fewer hospitalizations and reduced infection risks for
patients. At the same time, once our H2H
for HD machines is approved, hospitals and clinics will be able to make the
transition to Hemodiafiltration MDF therapy, while still using their existing
dialysis machines. We are excited about the opportunity to bring Nephros' MDF
innovation to the United States."
proposed trial is designed to
the safety and efficacy of the Nephros OLp r
and the Nephros MD 220 Hemodiafilter devices, which have been developed to
enable online HDF to be performed with a conventional ultrafiltration controlled
hemodialysis machine. Online HDF is a "convective" based renal replacement
therapy offering improved removal of uremic toxins, in particular
middle-molecular weight toxins such as beta-2-microglobulin (b2m). The trial
a prospective, multi-center trial whereby stable End-Stage
will be monitored during a first hemodialysis (control) period using their
current hemodialysis machine with a conventional high-flux dialyzer, followed
a second hemodiafiltration (test) period using their current hemodialysis