Navigation Links
Nephros Completes Pivotal U.S. Clinical Trial for its Hemodiafiltration Products
Date:6/6/2008

NEW YORK, June 6 /PRNewswire-FirstCall/ -- Nephros, Inc. (Amex: NEP), a medical device company, announced today that it has completed the pivotal U.S. clinical trial for its OLpur(TM) H2H module and OLpur(TM) MD220 filter for End Stage Renal Disease (ESRD) therapy.

"We're excited and pleased to have reached this important milestone. There is a broad range of literature supporting the advantages of hemodiafiltration (HDF) over dialysis for the ESRD patient, including studies supporting a substantial reduction in the relative risk of mortality. While HDF is prevalent in Europe, no on-line HDF system has yet been approved for use in the U.S. We believe our mid-dilution HDF technology can offer a vital advance in therapy to U.S. ESRD patients," said Norman Barta, Nephros' CEO.

Nephros is now in the process of preparing its submission to the Food and Drug Administration under section 510(k) of the Food, Drug and Cosmetics Act to obtain approval to sell its mid-dilution HDF products in the U.S. If timely approved, Nephros believes its products will be the first on-line HDF products available to ESRD clinics and patients in the U.S.

About Nephros, Inc.

Nephros, Inc., headquartered in New York, is a medical device company developing and marketing products in End Stage Renal Disease (ESRD) therapy and water ultrafiltration.

ESRD is a disease state characterized by the irreversible loss of kidney function. Nephros' HDF products are designed to improve the quality of life for the ESRD patient, while addressing the critical financial and clinical needs of the care provider. The OLpur(TM) H2H is an add-on module that allows the most common types of hemodialysis machines to be used for on-line HDF therapy. The OLpur(TM) MD220 filter employs our proprietary Mid-Dilution diafiltration technology and is sold and distributed throughout Europe. The Nephros HDF system removes a range of harmful substances more effectively 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.

The Nephros line of water-filtration products incorporates its patented cold sterilization filtration technology, the Dual Stage Ultrafilter (DSU). The DSU has the capability to filter out bacteria, parasites, viruses and other biotoxins to produce biologically safe water, and its dual-stage design reduces the risk and facilitates detection of filter failure. With initial applications targeted at infection-control and potable water solutions, the DSU is in a pilot-use program at a major U.S. medical center and has been selected for further development by the U.S. Marine Corps.

For more information on Nephros, please visit Nephros' website at http://www.nephros.com.

Forward-Looking Statements

Statements 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.

Forward-looking 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's 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 funding if and when needed or on favorable terms; (ii) to continue as a going concern; (iii) to liquidate its short-term investments when needed to fund its operations; (iv) to maintain compliance with the AMEX's continued listing standards; (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; (vi) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (vii) to have its technologies and products accepted in current or future target markets; or (viii) 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, including Nephros' Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007, and Nephros' Quarterly Report on Form 10-Q for the period ended March 31, 2008. Investors and security holders are urged to read these documents free of charge 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.


'/>"/>
SOURCE Nephros, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Arno Therapeutics, Inc. Completes $18 Million Financing and Reverse Merger with Laurier International, Inc.
2. Jazz Pharmaceuticals, Inc. Completes Enrollment in First of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
3. NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
4. Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
5. Ikaria Completes Dosing of Phase 1a Clinical Study for IK-1001 (Sodium Sulfide) for Injection
6. Cerenis Therapeutics Completes Phase I Clinical Trial of CER-002 for Treatment of Cardiovascular Disease
7. Novavax Completes Enrollment in Phase I/IIa Pandemic Influenza Vaccine Clinical Trial
8. VIA Pharmaceuticals Completes Enrollment in Phase 2 Acute Coronary Syndrome (ACS) Trial
9. PacificGMP Completes GMP Product Fill for Trius Therapeutics
10. Cardinal Health Completes Enturia Acquisition
11. DaVita Clinical Research Completes Record Number of Renal Trials in 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Research and Markets has announced the addition of the ... ... capillary electrophoresis market to grow at a CAGR of 7.06% during ... Market 2017-2021, has been prepared based on an in-depth market analysis ... and its growth prospects over the coming years. The report also ...
(Date:3/23/2017)... 23, 2017  Drug diversion is a significant ... deadly overdoses. A new oral fluid monitoring test, ... , reports more detailed and actionable information to ... improve therapy adherence, patient safety, and help to ... Oral fluid Rx Evaluation (CORE) system is the ...
(Date:3/23/2017)... SAN DIEGO , March 23, 2017 /PRNewswire/ ... for fast and accurate identification of individuals who ... at risk for a rare yet potentially deadly ... seizures and bipolar disorder.  The gene HLA-B*15:02 ... hypersensitivity reactions such as Stevens-Johnson syndrome and toxic ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... A recent report from the National ... preparation programs. The NCTQ report suggests, based on a review of GPA and SAT/ACT ... teacher quality in the U.S. It argues that this higher bar should be set ...
(Date:3/23/2017)... ... March 23, 2017 , ... Texas Physical Therapy ... 960 Gruene Road in Building 2. The clinic is the group’s second in New ... says opening the company’s second New Braunfels location brings things full circle for the ...
(Date:3/23/2017)... and Grimsby, Ontario (PRWEB) , ... March 23, 2017 , ... The MBI “Hall of ... industry or whose acts have had a significant impact on the careers of all others ... Marketing with NRB Inc. was inducted into the MBI’s Hall of Fame. The induction ...
(Date:3/23/2017)... ... 23, 2017 , ... March is National Kidney Month – the perfect time ... to maintaining good health. Every day, two kidneys filter about 120 to 150 quarts ... your blood, eliminating waste, regulating fluid levels and blood pressure, supporting bone health and ...
(Date:3/23/2017)... ... March 23, 2017 , ... Hakim Unique Group (HUG) ... company California Healthcom Group (CHG). , The HUG investment is a landmark ... in California, CHG is a growing, internationally recognized healthcare management, technology, and services ...
Breaking Medicine News(10 mins):