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Nephros Receives Initial FDA Response to 510(k) Application for Hemodiafiltration System
Date:11/10/2011

" or similar words. For such statements, we claim 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 our 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:

  • we may not be able to continue as a going concern;
  • we may not be able to obtain funding if and when needed or on terms favorable to us in order to continue operations;
  • we may not obtain appropriate or necessary regulatory approvals to achieve our business plan or effectively market our products including, without limitation, FDA approval of our HDF system;
  • products that appeared promising to us in research or clinical trials may not demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials;
  • we may encounter problems with our suppliers and manufacturers;
  • we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures;
  • HDF therapy may not be accepted in the United States and/or our technology and products may not be accepted in current or future target markets, which could lead to failure to achieve market penetration of our products;
  • we may not be able to sell our ESRD therapy or water filtration products at competitive prices or profitably;
  • we may not be able to secure or enforce adequate legal protection, including patent protection, for our products; and
  • we may not be able to achieve sales growth in Europe and Canada or expand into other key geographic markets.

More detailed information about us and the risk factors that may affect the
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SOURCE Nephros, Inc.
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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
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