Navigation Links
Nephros Receives 510k Approval to Market Additional Ultrafiltration Products

RIVER EDGE, N.J., July 21, 2011 /PRNewswire/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today announced that the Company has received 510k clearance from the U.S. Food and Drug Administration to market its MSU and SSU ultrafilters to filter out biological contaminants from water and bicarbonate solution used in hemodialysis procedures.

"Nephros is pleased to have received clearance from the FDA to market the MSU and SSU for hemodialysis applications," said Dr. Paul Mieyal, Acting CEO of Nephros, Inc.  "The MSU and SSU represent extensions of the Nephros ultrafiltration product line and enable Nephros products to address a wider range of fluid flow requirements."

About Nephros Ultrafiltration Products

The Nephros DSU, MSU, and SSU are FDA cleared devices for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.  Within the U.S., there are approximately 4,500 clinics providing over 50 million dialysis treatments to 350,000 patients annually. To perform hemodialysis, ultrapure water is crucial to the production of dialysate. Dialysis clinics have water purification systems; however, microbial contaminants can originate from the water treatment system, the water distribution loop, or the dialysate concentrates.  Nephros ultrafilters filter out substances down to the 0.005 micron level and address dialysate contamination at crucial points: after the reverse osmosis module and at the dialysis machine entrance from the water distribution loop. Nephros ultrafilters can be used as the last step in the water purification process to ensure that ultrapure water is used for dialysis procedures. Regular use of Nephros ultrafilters offers an affordable safety measure when utilized with modern water treatment systems and optimally maintained hemodialysis machines.  Recent data have shown that the Nephros DSU, when used as part of the water purification system for dialysis systems, may reduce the required dosage of erythropoietin stimulating agents, which we believe will provide a unique benefit to patients.

About Nephros, Inc.

Nephros, Inc., headquartered in River Edge, 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.

The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products, which includes the MSU and SSU ultrafilters. 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. Nephros' DSU ultrafilters are being evaluated at several major U.S. medical centers for infection control. Nephros ultrafilter technology has also been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.

For more information about Nephros, please visit the company's website at

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' 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 continue as a going concern; (ii) to obtain additional funding when needed or on favorable terms; (iii) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (iv) to have its technologies and products accepted in current or future target markets; (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; or (vi) 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. Investors and security holders are encouraged to read these documents on the SEC's website at Nephros does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

SOURCE Nephros, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Nephros Completes Pivotal U.S. Clinical Trial for its Hemodiafiltration Products
2. Nephros Reports 2009 Third Quarter Financial Results
3. Nephros Signs Canadian Distribution Agreement with Bellco Health Care Inc.
4. Nephros Signs Development Agreement with STERIS
5. Nephros Reports 2010 First Quarter Financial Results
6. Nephros and AmeriWater Announce Dual Stage Ultrafilters to be a Standard Component of MRO Series Water Treatment Systems
7. Nephros Receives Formal Response from FDA for 510(k) Application for Hemodiafiltration System
8. Nephros Reports 2010 Second Quarter Financial Results
9. Nephros Completes Bridge Financing and Announces Stockholder Rights Offering
10. Nephros Reports 2010 Third Quarter Financial Results
11. Nephros Rights Offering Registration Statement Declared Effective
Post Your Comments:
(Date:12/1/2015)... Pa. , Dec. 1, 2015  Today, ... announced the launch of CareFront, a first-of-its-kind population ... patients diagnosed with cancer. Designed to be built ... diagnosed cancer patients with resources for their care ... The program also offers tools to help patients ...
(Date:12/1/2015)... , Dec. 1, 2015   Craneware, ... value cycle solutions, today announced the company will ... Pharmacy ChargeLink ® solution at the ... Midyear Clinical Meeting . The new features are ... process of monitoring and managing enterprise-wide pharmacy charges ...
(Date:12/1/2015)... 1, 2015  Booth #3506 – Claymount is featuring its ... meeting of the Radiological Society of North America ... year. Based in the Netherlands , Claymount ... Systems (NYSE: VAR ) and is one of the ... solid state automatic exposure control systems for controlling dose during ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... ... is the first health care provider in the region to offer the vBloc® Therapy ... vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients over ... to 45 kg, or a BMI of at least 35 to 39.9 kg with a ...
(Date:12/1/2015)... ... December 01, 2015 , ... Dr. Paul Vitenas, one of the ... been named by MedEsthetics magazine as the Best Single Physician Practice in the nation. ... many elite aesthetic physicians honored by the industry publication. , Dr. Vitenas said ...
(Date:12/1/2015)... Delaware (PRWEB) , ... December 01, 2015 , ... ... winner at the 7th Annual 2015 Golden Bridge Business Awards under the New ... is a zero capex web based sample management software that helps ...
(Date:12/1/2015)... ... 2015 , ... For many X-rays taken at hospitals, doctors’ ... by the radiologist. The marking utensils are so small, however, they are difficult ... way to alleviate this problem. , He developed the patent-pending MARK N SHOW ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... it has been awarded a fixed price per sprint agile development contract to ... at $34 million over five years, provides software engineering, infrastructure, as well as ...
Breaking Medicine News(10 mins):