SOURCE: Nephros, Inc.

March 01, 2007 08:30 ET

Nephros Completes Informational Request From the FDA on Investigational Device Exemption Application

Nephros MD and H2H Technologies Clinical Trials Expected to Commence in March 2007

NEW YORK, NY -- (MARKET WIRE) -- March 1, 2007 -- Nephros, Inc. (AMEX: NEP) today reported that the Company has completed and submitted its response to the Food and Drug Administration (FDA) for the two informational requests related to the conditional approval of the Company's Investigational Device Exemption (IDE) Application to begin a human clinical trial of the Company's OLpur™ H2H™ Hemodiafiltration Module and OLpur™ MD 220 Hemodiafilter. The Company believes it has completed the regulatory filings required to commence its clinical trials in March. The Company also noted that it is in the final stages of gaining approval from one or more Institutional Review Boards (IRBs), the final step in the process before the commencement of its clinical trial.

Trial:

The proposed trial is designed to assess the safety and efficacy of the Nephros OLpur™ H2H™ Module and the Nephros MD 220 Hemodiafilter devices, which have been developed to enable online hemodiafiltration ("HDF") 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). 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 complete a quality of life survey at the end of each study period as a means to better assess patient perceptions during treatment. Upon successful completion of the trial, the Company plans to seek FDA 510(k) approval to market both the H2H Module and the MD 220 Hemodiafilter. The Company currently anticipates seeking such approval in early 2008.

About Nephros, Inc.

Nephros, Inc., headquartered in New York, is a medical device company developing and marketing products 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. Nephros believes that its products, particularly its Mid-Dilution Hemodiafiltration ("MDHDF") therapy, are designed to remove a range of harmful substances more effectively, and more cost-effectively, than existing ESRD treatment methods; particularly with respect to substances known collectively as "middle molecules," due to their molecular weight, that 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 MDHDF products are currently being used in over fifty clinics in Europe, and are distributed by Bellco SpA in Italy, France, Spain and Belgium.

Nephros also markets a line of water filtration products, the Dual Stage Ultrafilter ("DSU"). The Company's patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses and parasites. The DSU proprietary design provides dual-stage filtration reducing the risk of filtration failure. With initial focus on health care, the DSU is in a pilot-use program at a major medical center and has been selected for further development by the US Marine Corps. The Company considers the DSU a significant breakthrough in providing affordable and reliable water filtration. The DSU is based on Nephros' proprietary water filtration technology originally designed for medical use in its H2H machine, and is a complimentary product line to the Company's main focus, the End Stage Renal Disease therapy business.

For more information, please visit the Company's website, www.nephros.com.

Forward-Looking Statements

This news release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements may include statements regarding the efficacy and intended use of Nephros' technologies, 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 preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. For such statements, Nephros claims the protection of the Private Securities Litigation Reform Act of 1995.

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 the control of Nephros. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that: (i) products that appeared promising to Nephros in research or clinical trials may not demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials; (ii) Nephros may not obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (iii) product orders may be cancelled, patients or customers currently using Nephros' products may cease to do so and patients or customers expected to begin using Nephros' products may not; (iv) Nephros' technology and products may not be accepted in current or future target markets, which could lead to the failure to achieve market penetration of Nephros' products; (v) Nephros may not be able to sell its ESRD or water filtration products at competitive prices or profitably; (vi) Nephros may not be able to satisfy its debt obligations when they become due and payable; (vii) Nephros may not be able to build key relationships with physicians, clinical groups and government agencies, pursue or increase sales opportunities in Europe or elsewhere, or be the first to introduce hemodiafiltration therapy in the United States; (viii) Nephros may not be able to secure or enforce adequate legal protection, including patent protection, for its products; (ix) Nephros' water filtration products and technologies may not achieve expected reliability, performance and endurance standards; (x) Nephros' water filtration products and technology may not achieve market acceptance, including among hospitals, or may not be deemed suitable for other commercial, industrial or retail applications; and (xi) Nephros may be unable to show progress consistent with its plan of compliance to meet the American Stock Exchange's continued listing standards or may be otherwise unable to timely regain compliance with the AMEX listing standards. 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 Securities and Exchange Commission, including Nephros' Annual Report on Form 10-KSB filed with the SEC for the fiscal year ended December 31, 2005 and its Quarterly Report on Form 10-QSB filed with the SEC for the fiscal quarter ended September 30, 2006. Investors and security holders are urged to read those documents free of charge on the SEC's web site at 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.

Contact Information


  • CONTACTS:

    Norman Barta
    Nephros, Inc.
    212-781-5113

    Paul G. Henning
    Cameron Associates
    212 554-5462
    Email Contact