Nephros Receives Conditional Approval From The FDA Of IDE Application

New York - Nephros, Inc. recently 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 OLpûr H₂H Hemodiafiltration Module and OLpûr MD 220 Hemodiafilter. Nephros has been granted this approval on the condition that, by March 5, 2007, it will submit a response to two informational questions from the FDA. The Company has already provided a partial response to these questions. Nephros 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 of seeking approvals from the relevant IRBs.

Nephros plans to conduct the trial at three clinics in the Greater New York area:

• Columbia University Dialysis Center (Dr. Anthony Valeri, M.D., Associate Professor of Clinical Medicine, Columbia University, College of Physicians & Surgeons, NY, site principal investigator);
• Bronx Dialysis Center (Dr. Robert Lynn, M.D., Clinical Associate Professor of Medicine, Albert Einstein College of Medicine, site principal investigator); and
• DCI, North Brunswick, New Jersey (Dr. Toros Kapoian M.D., FACP, Associate Professor of Medicine, Robert Wood Johnson Medical School, site principal investigator).

Columbia University Dialysis Center and Bronx Dialysis Center are affiliated with or managed by DaVita, Inc. and DCI is affiliated with or managed by Dialysis Clinic, Inc.

Dr. 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.

Nephros and Dr. Stern anticipate that the introduction of online hemodiafiltration (HDF) into the clinical arena for dialysis-dependent patients will provide a significant 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 and mortality. Dr. 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 an 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."

Norman 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."

Nephros Mid-Dilution Technology:

Hemodiafiltration 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 that optimizes the removal of both small toxins and middle-molecules by offering the 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 costs.

Nephros believes that its OLpûr MDHDF filter series (including the OLpûr MD220) are the only filters designed specifically for HDF and offer superior toxin clearance as well as improved performance over conventional hemodialyzers. The Nephros OLpûr MDHDF filter series, having received CE Marking in Europe, is in clinical use in 12 European countries. The OLpûr H₂H offers clinics a simple way to upgrade hemodialysis therapy to HDF therapy without incurring the costs and inconveniences generally associated with HDF machines. The OLpûr H₂H is an add-on module that converts the most common types of hemodialysis machines into HDF-capable machines. As a result, clinics using the OLpûr H₂H will be able to introduce patients to HDF therapy without replacing an existing dialysis machine base or incurring large machine-replacement costs.

Commenting on the IDE approval, William Fox, Executive Chairman of Nephros, said, "According to industry sources, the number of End-Stage Renal Disease patients worldwide is expected to grow approximately 50% to 2.4 million by 2010. Our MD 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 Module 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."

Trial:

The proposed trial is designed to assess the safety and efficacy of the Nephros OLpûr H₂/H Module 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 is a prospective, multi-center trial whereby stable End-Stage Renal Disease patients will be monitored during a first hemodialysis (control) period using their current hemodialysis machine with a conventional high-flux dialyzer, followed by a second hemodiafiltration (test) period using their current hemodialysis machine, the Nephros H₂H Module, and the Nephros MD 220 Hemodiafilter. During the trial, the occurrence of adverse events and adverse symptoms will be recorded as primary study endpoints, while blood chemistries (including b2m and C-reactive protein) and quality of the online infusion fluid will be measured as secondary endpoints. In addition, patients will fill out a quality of life survey at the end of each study period as a means to assess if they are feeling better on either of the two treatments methods. Upon successful completion of the trial, the Company plans to seek FDA approval to market both the H₂H Module and the MD 220 Hemodiafilter. The Company currently anticipates seeking such approval in early 2008.

For more information on Nephros you can visit the Company's website, www.nephros.com

SOURCE: Nephros, Inc.