Navigation Links
Nephros Provides Update on 510k Applications
Date:2/24/2009

RIVER EDGE, N.J., Feb. 24 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that is has received initial responses from the FDA's review of the company's 510(k) submissions for dialysis devices.

510k Application for OLpur MD220 Dialyzers and H2H Hemodiafiltration Module

On November 14, 2008, Nephros submitted a 510k application to the FDA for approval to market its leading-edge hemodiafiltration ("HDF") products for end-stage renal disease in the U.S. The application details Nephros's OLpur MD220 diafilter and Nephros's OLpur H2H Hemodiafiltration module. Following its review of the application, the FDA has requested additional information. Nephros intends to provide a formal response to the FDA's questions prior to the deadline of March 15, 2009. Per FDA guidelines, once submitted, the FDA will have 90 days to review the additional information provided by the company.

Nephros's OLpur MD220 filter is designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Diafiltration technology. Nephros's OLpur H2H Hemodiafiltration module enables existing dialysis machines to be used for HDF therapy. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.

510k Application for Dual Stage Ultrafilters

On October 7, 2008, Nephros filed a 510k application for approval to market its Dual Stage Ultrafilters (DSU) to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA has requested additional information. The company today provided a formal response to the FDA. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the company.

About Nephros, Inc.

Nephros, Inc., headquartered in New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.

The Nephros hemodiafiltration ("HDF") system is 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. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, 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. Nephros ESRD products are sold and distributed throughout Europe and are currently being used in over fifty clinics in Europe.

The Nephros Dual Stage Ultra-filter (DSU) is the basis for Nephros's line of water filtration products. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. Sale of the DSU has begun at several major U.S. medical centers for infection control and has been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.

For more information on Nephros, please visit its 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 maintain compliance with the AMEX's continued listing standards; (ii) to obtain funding if and when needed or on favorable terms; (iii) to continue as a going concern; (iv) 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; (v) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (vi) 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's filings with the SEC, including Nephros's Annual Report on Form 10-KSB filed with the SEC for the fiscal year ended December 31, 2007, and Nephros's Quarterly Report on Form 10-Q for the periods ended September 30, 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©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Nephros Common Stock Now Quoted in Pink Sheets
2. Nephros Receives Notice of Intention to Delist from AMEX
3. Nephros, Inc. Receives the 2009 Frost & Sullivan Medical Device Patient Care Company of the Year Award
4. Nephros Exhibiting at Denver, Colorado APIC Conference June 15th-19th
5. Nephros Reports 2008 First Quarter Financial Results
6. Nephros Exhibits at the XLV ERA-EDTA Congress in Stockholm, Sweden, May 10-13, 2008
7. Nephros Strengthens Commercialization Team with Addition of Marketing Executive
8. CRH provides Partnership Program update
9. Medicsight PLC Provides Business Update
10. The Journal of Nutrition Publishes Study Indicating that AHCC(R) Provides Immune Support against West Nile Virus
11. eFoodSafety.com Provides Revenue Guidance for FY 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... ... May 24, 2016 , ... ... managed services today announced a strategic partnership with Five9 (Nasdaq: FIVN), a ... Altura, one of Avaya’s largest Platinum Business Partners, is a leading provider ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... Center at Sentara Northern Virginia Medical Center located in Woodbridge, VA. The ... surgical services into a single site. , The new 2 story building houses ...
(Date:5/24/2016)... ... May 24, 2016 , ... New Brunswick, New Jersey: This year marks Children’s ... fullest potential. To commemorate the anniversary, the hospital has themed the milestone “Hats Off” ... Children’s Specialized Hospital Foundation on Saturday, May 21, at Johnson Park in Piscataway, New ...
(Date:5/24/2016)... Bahama (PRWEB) , ... May 24, 2016 , ... Regenerative ... Such breakthroughs in adult stem cell therapy technology, protocols and patient results as have ... emerging field to become a more accessible standard of care for patients worldwide. , ...
(Date:5/24/2016)... ... , ... Loma Linda University Health (LLUH) has officially broken ground on the ... 3,000 people looked on as the shovels hit the dirt at the community groundbreaking ... During the program, Richard H. Hart, MD, DrPH, president, LLUH, recapped the history of ...
Breaking Medicine News(10 mins):
(Date:5/23/2016)... --Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today the start ... hands-on learning experience is a 12-week summer program, May ... and Internship programs bring participants to ... are provided optional housing free of charge through Diplomat ... Riverfront Residence Hall to foster communication and collaboration among ...
(Date:5/23/2016)... , May 23, 2016 ... Market Size, Share, Development, Growth and Demand Forecast ... Single and Other), by Application (Drug Discovery and ... End Users (Pharmaceuticals, Life Science and Biotechnology, Academic ... P&S Market Research, the global mass spectrometry ...
(Date:5/23/2016)... 2016 The World Health Organization (WHO) expanded the ... include adolescents aged 13 years, and above. Effective immediately, the ... adult and adolescent males in the 14 priority countries in ... the first male circumcision device to receive WHO Prequalification on ... Horowitz said: " The expanded use of ...
Breaking Medicine Technology: