Dialysis world news


Renal Ventures Management Reopens Somerville Dialysis Clinic After Hurricane ... - MarketWatch (press release)

SOMERVILLE, N.J., Apr 23, 2012 (BUSINESS WIRE) -- Renal Ventures Management LLC, a leading provider of dialysis services for patients suffering from chronic kidney failure, announced today that it has reopened its state-of-the-art outpatient dialysis facility located in Somerville, N.J. The Renal Center of Somerville LLC, which was damaged due to flooding from Hurricane Irene in August 2011, officially began treating patients on March 30, 2012.

"With the help of a dedicated construction team and cooperation from local government officials, the $1 million renovation was completed in just six months for a project that would typically take nearly a year," said Karen Marcus, Divisional Director of Operations East.

"The re-opening of the Somerville clinic is a momentous occasion for our community. The new clinic represents the pinnacle of renal care in a warm and inviting environment; it is something we are truly proud of. We look forward to welcoming back our patients," said Dr. Eric Manning, Joint Venture Partner and Medical Director.

Renal Ventures Management said over 45 patients have resumed their weekly dialysis treatments. That represents an increase from the number of patients receiving treatment at the clinic prior to the storm. The company credits the strong show of patient support to its qualified staff and history of quality care.

"Undergoing dialysis is a life-long commitment for me to maintain my health and well-being," said Joanne Servino, Renal Center of Somerville LLC patient since 2009. "It can also be physically and emotionally challenging. The people at the Somerville clinic have always eased the burden of dialysis by taking the time to get to know me as a person and not just treating me as another patient. I look forward to getting back to the familiar and friendly faces."

Renal Ventures Management operates 10 outpatient dialysis facilities in New Jersey. The company has developed a reputation as a first choice provider of dialysis services in the area as a result of its industry-leading clinical care outcomes and proactive collaboration with its hospital and physician partners.

The Renal Center of Somerville LLC provides in-center hemodialysis and home peritoneal dialysis services to its patients. Currently, the facility operates Monday, Wednesday and Friday from 5 a.m. to 9 p.m. To schedule an appointment or facility tour, contact Digna Gutierrez, the facility's clinic coordinator, at 908-450-0396.

Renal Center of Somerville LLC 1 Route 206 North Somerville, NJ 08876 Phone: 908-450-0396 Fax: 908-450-0399

About Renal Ventures Management LLC

Renal Ventures Management LLC is a leading provider of dialysis services in the U.S. The company partners with hospitals and physicians to provide patients suffering from chronic kidney failure with knowledgeable, compassionate and quality-focused care in comfortable clinic settings. For its hospital and nephrologist partners, Renal Ventures Management provides management expertise and patient-focused care operations which center around collaboration, quality and effectiveness. Headquartered in Lakewood, Colorado, the company operates 33 dialysis centers and manages 18 acute contracts in six states. For more information, visit www.renalventures.com .

SOURCE: Renal Ventures Management LLC




        
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Nephros Appoints John C. Houghton as President and Chief Executive Officer - MarketWatch (press release)

RIVER EDGE, N.J., April 23, 2012 /PRNewswire via COMTEX/ -- Nephros, Inc. /quotes/zigman/4348490 NEPH -2.06% , a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today announced that effective April 20, 2012, John C. Houghton has been appointed as President and Chief Executive Officer. In addition, Mr. Houghton is expected to be appointed to the board of directors of Nephros. Effective upon Mr. Houghton's appointment, Dr. Paul Mieyal stepped down as acting CEO of Nephros and will remain as a member of the board of directors of Nephros.

Mr. Houghton has over 25 years of commercialization experience in the pharmaceutical and medical device fields. He has direct experience in building out global commercial organizations including marketing, sales, sales operations, customer service, business analytics and new product development and has also been directly responsible for successfully licensing products and leading joint ventures and partnerships.

Mr. Houghton most recently served as President and CEO of CorMedix Inc., a pharmaceutical company focused on therapeutic products for the treatment of cardio-renal disease. While President and CEO, Mr. Houghton led the acquisition of the company's product candidates and the completion of its initial public offering. Prior to assuming the role of President and CEO, he was the Chief Business Officer for CorMedix. Before joining CorMedix, Mr. Houghton established the global sales and marketing infrastructure for the Biotech division of Stryker Corp. Prior to Stryker, he worked with Aventis and predecessor companies for more than 14 years. During his time at Aventis he led the global marketing of Nasacort, served as commercial lead on the Aventis-Millennium inflammation collaboration, and functioned as the global new products commercialization head for respiratory, inflammation, cardiovascular, and metabolism products. Mr. Houghton received his B.Sc. from Liverpool John Moores University, United Kingdom.

"After an extensive search process, we look forward to having John in place and driving the company's growth," said James S. Scibetta, Chairman of Nephros. "John's strengths in commercialization and business development are attractive assets which the board feels can add significant value to Nephros."

"I am excited to be joining the Nephros team, and I believe that the company has a very promising future," said Mr. Houghton. "My immediate goals are to focus on leveraging the just announced agreement with Medica to pursue an aggressive strategy aimed at expansion of Nephros's ultrafiltration product sales and to continue ongoing communication with the FDA with the intent of obtaining clearance for the company's hemodiafiltration system. In the intermediate term, Nephros will explore and pursue additional market opportunities for its products and technology while seeking to meet the requirements for relisting of the company's stock on a national exchange."

DHR International provided executive search services for the recruitment of Mr. Houghton to Nephros.

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. The Nephros DSU, MSU, and SSU are FDA cleared for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Nephros' DSU ultrafilters are being evaluated at several major U.S. medical centers for infection control. Nephros has also developed its UF-40 ultrafilter for purification of drinking water by soldiers in the field.

For more information about Nephros, please visit the company's website at www.nephros.com .

Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements include statements regarding the efficacy and intended use of our technologies under development, 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, 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 realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our other periodic reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC's web site at www.sec.gov . We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

SOURCE Nephros, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

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Keryx Biopharmaceuticals Announces Positive Top-Line Results from Phase 3 ... - MarketWatch (press release)

NEW YORK, April 23, 2012 /PRNewswire via COMTEX/ -- Keryx Biopharmaceuticals, Inc. /quotes/zigman/83561/quotes/nls/kerx KERX +2.26% , announced today that its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), has announced positive top-line results from a Phase 3 study of ferric citrate in Japan for the treatment of hyperphosphatemia in end-stage renal disease patients on hemodialysis. This study is part of an ongoing Phase 3 program for ferric citrate in Japan for the treatment of hyperphosphatemia.

The Phase 3 study, conducted in Japan, was an open-label, randomized study evaluating the efficacy and safety of ferric citrate against an active control, sevelamer hydrochloride, over 12 weeks in hemodialysis patients with hyperphosphatemia. In the top-line results, which evaluated the change of serum phosphorus from baseline, the primary endpoint of efficacy met non-inferiority to sevelamer hydrochloride. Furthermore, there were no clinically significant findings on safety and tolerability of ferric citrate within the treatment period.

JT/Torii stated that it is aiming to submit the marketing application for ferric citrate in Japan in the fiscal year ending March 31, 2013.

Ron Bentsur, Chief Executive Officer of Keryx, said, "We congratulate our partner, JT/Torii, on their successful Phase 3 study and we are excited by their progress. We are also encouraged about our partner's plans to file their marketing application in Japan within less than a year, similar to our expected timelines for the U.S. NDA and European MAA filings." Mr. Bentsur added, "We are enthusiastic about Zerenex's potential differentiated product profile and its prospects for becoming an important part of the treatment of hyperphosphatemia in dialysis patients worldwide."

Zerenex(TM) (ferric citrate), a ferric iron-based phosphate binder, is also in a Phase 3 clinical program in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis, which is being conducted pursuant to a Special Protocol Assessment agreement with the FDA.

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc.

Sublicense Agreement with Japan Tobacco & Torii Pharmaceutical

In September 2007, Keryx sublicensed to JT/Torii the exclusive rights for the development and commercialization of its hyperphosphatemia drug, Zerenex (ferric citrate), in Japan. The licensing arrangement calls for JT/Torii to pay to Keryx up to $100 million in up-front license fees and payments upon the achievement of specified milestones, of which $28 million has been received by Keryx to date. In addition, upon commercialization, JT/Torii will make royalty payments to Keryx on net sales of the drug in Japan. JT/Torii are responsible for all development and commercialization costs in Japan.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease and cancer. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing KRX-0401 (perifosine), which is in Phase 3 clinical development for multiple myeloma. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex(TM) (ferric citrate) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability, and our Japanese partner's ability, to successfully and cost-effectively complete clinical trials for Zerenex (ferric citrate); the risk that the data (both safety and efficacy) from the ongoing Phase 3 trials will not coincide with the data analyses from previous clinical trials reported by the Company; our ability to meet anticipated development timelines for Zerenex due to clinical trial results, manufacturing capabilities or other factors; if we determine that all trials of KRX-0401 (perifosine) should be terminated, our ability to successfully adjust our strategy and reduce our operating expenses relating to KRX-0401 clinical trials in order to properly support the trials of Zerenex; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.




        KERYX CONTACT:
        Lauren Fischer
        Director - Investor Relations
        Keryx Biopharmaceuticals, Inc.
        Tel: 212.531.5965
        E-mail: 
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SOURCE Keryx Biopharmaceuticals, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

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Nephros Announces Strategic License and Supply Agreement with Medica S.p.A for ... - MarketWatch (press release)

RIVER EDGE, N.J., April 23, 2012 /PRNewswire via COMTEX/ -- Nephros, Inc. /quotes/zigman/4348490 NEPH -2.06% , a medical device company developing and marketing filtration products for therapeutic applications, infection control, and advanced water purification solutions, today announced that the company has entered into a strategic license and supply agreement with Medica S.p.A. That agreement, which is effective April 23, 2012, grants Nephros exclusive global rights, with specific exceptions, to market products based on Medica's proprietary Medisulfone ultrafiltration technology.

MEDICA S.p.A is located in Medolla, Italy, the largest European center for developing and manufacturing of medical products. MEDICA manufactures and sells a complete range of medical devices in the areas of Chronic and Acute Dialysis, Gastroenterology, Urology, Oncology, Cardiology and microbiological water purification for use in the hospital sector. The Medica Water Division, based in Iglesias, Italy, manufactures a proprietary hollow fiber polysulfone synthetic membrane for blood and water purification in medical and industrial applications. For more information about MEDICA, please visit www.medicasrl.com

"Medica and Nephros have a long history of collaboration, and I am pleased to formalize our relationship via today's agreement which positively addresses the interests of both companies," said Luciano Fecondini, CEO of Medica.

"We are excited to solidify our relationship with Medica through this agreement," said Dr. Paul Mieyal. "The Medisulfone technology is a differentiated component of ultrafiltration applications. This agreement consolidates the ultrafiltration products and intellectual property of Nephros and Medica into a comprehensive product line and enables Nephros to market these products on an exclusive basis globally."

Summary of Terms

Under the terms of the agreement, Medica will provide an exclusive license to Nephros for its ultrafiltration technology on a worldwide basis for the period April 23, 2012 to December 31, 2022. Medica will retain certain product and marketing rights for Italy for the period from April 23, 2012 to April 23, 2015, at which time Nephros will have the option to transition Italy into the global exclusive license for no additional consideration. In exchange for the license, Nephros will pay to Medica 1.5 million euro in two installments: 500,000 euro on April 23, 2012 and 1,000,000 euro on January 25, 2013. As part of the agreement, Nephros has granted to Medica 300,000 options to purchase Nephros common stock which will vest over the first three years of the agreement. For the period April 23, 2014 through December 31, 2022, Nephros will pay to Medica a royalty of 3% of net sales.

Nephros Ultrafiltration Products

The Association for the Advancement of Medical Instruments' (AAMI) adoption of more stringent water purity standards for dialysis applications combined with significant observational studies showing a substantial reduction in required erythropoietin dosing when the Nephros DSU is utilized during dialysis therapy has led to significantly increased interest in Nephros ultrafiltration products. In addition to the DSU, Nephros has received FDA 510(k) clearance for its SSU and MSU filters to enable these additional ultrafiltration products to be used in dialysis applications.

Nephros has introduced product line extensions for the hospital infection control market which include a more durable filter design to withstand the higher pressures of hospital plumbing, filter covers to improve the aesthetics of the finished installations in hospital showers, and the SafeSpout as an effective, longer lasting, point of use filter to address acute outbreak scenarios. In a study involving two major U.S. hospitals, the Nephros DSU system was shown to be effective in reducing waterborne Legionella bacteria to undetectable levels, an effect which was sustained for the 3-month study period.

Nephros has an ongoing collaboration agreement with STERIS Corp. related to its ultrafiltration technology.

In response to a Request For Information (RFI) from the U.S. Army, Nephros submitted its UF-40 ultrafilter for consideration as part of the standard issue hydration pack for soldiers in the field. Nephros has been informed by the U.S. Army Public Health Command that its UF-40 filter has been validated to meet the military's NSF P248 standard for emergency military operations as a microbiological water purifier. Nephros believes that its UF-40 filter is the only stand-alone filter to date to have met the performance criteria of the NSF P248 standard without secondary disinfection steps. The Army has not to date issued a Request For Proposal (RFP), and Nephros has no information regarding when or if an RFP applicable to the UF-40 ultrafilter may be put forth by the U.S. Army.

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. The Nephros DSU, MSU, and SSU are FDA cleared for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Nephros' DSU ultrafilters are being evaluated at several major U.S. medical centers for infection control. Nephros has also developed its UF-40 ultrafilter for purification of drinking water by soldiers in the field.

For more information about Nephros, please visit the company's website at www.nephros.com .

Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements include statements regarding the efficacy and intended use of our technologies under development, 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, 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 realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our other periodic reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC's web site at www.sec.gov . We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

SOURCE Nephros, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

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Nephros Announces Strategic License and Supply Agreement with Medica S.p.A for ... - DigitalJournal.com (press release)

RIVER EDGE, N.J., April 23, 2012 /PRNewswire/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and advanced water purification solutions, today announced that the company has entered into a strategic license and supply agreement with Medica S.p.A.  That agreement, which is effective April 23, 2012, grants Nephros exclusive global rights, with specific exceptions, to market products based on Medica's proprietary Medisulfone ultrafiltration technology.

MEDICA S.p.A is located in Medolla, Italy, the largest European center for developing and manufacturing of medical products.  MEDICA manufactures and sells a complete range of medical devices in the areas of Chronic and Acute Dialysis, Gastroenterology, Urology, Oncology, Cardiology and microbiological water purification for use in the hospital sector.  The Medica Water Division, based in Iglesias, Italy, manufactures a proprietary hollow fiber polysulfone synthetic membrane for blood and water purification in medical and industrial applications.  For more information about MEDICA, please visit www.medicasrl.com

"Medica and Nephros have a long history of collaboration, and I am pleased to formalize our relationship via today's agreement which positively addresses the interests of both companies," said Luciano Fecondini, CEO of Medica.

"We are excited to solidify our relationship with Medica through this agreement," said Dr. Paul Mieyal. "The Medisulfone technology is a differentiated component of ultrafiltration applications. This agreement consolidates the ultrafiltration products and intellectual property of Nephros and Medica into a comprehensive product line and enables Nephros to market these products on an exclusive basis globally."

Summary of Terms

Under the terms of the agreement, Medica will provide an exclusive license to Nephros for its ultrafiltration technology on a worldwide basis for the period April 23, 2012 to December 31, 2022.  Medica will retain certain product and marketing rights for Italy for the period from April 23, 2012 to April 23, 2015, at which time Nephros will have the option to transition Italy into the global exclusive license for no additional consideration. In exchange for the license, Nephros will pay to Medica 1.5 million euro in two installments: 500,000 euro on April 23, 2012 and 1,000,000 euro on January 25, 2013.  As part of the agreement, Nephros has granted to Medica 300,000 options to purchase Nephros common stock which will vest over the first three years of the agreement.  For the period April 23, 2014 through December 31, 2022, Nephros will pay to Medica a royalty of 3% of net sales.

Nephros Ultrafiltration Products

The Association for the Advancement of Medical Instruments' (AAMI) adoption of more stringent water purity standards for dialysis applications combined with significant observational studies showing a substantial reduction in required erythropoietin dosing when the Nephros DSU is utilized during dialysis therapy has led to significantly increased interest in Nephros ultrafiltration products. In addition to the DSU, Nephros has received FDA 510(k) clearance for its SSU and MSU filters to enable these additional ultrafiltration products to be used in dialysis applications.

Nephros has introduced product line extensions for the hospital infection control market which include a more durable filter design to withstand the higher pressures of hospital plumbing, filter covers to improve the aesthetics of the finished installations in hospital showers, and the SafeSpout as an effective, longer lasting, point of use filter to address acute outbreak scenarios.  In a study involving two major U.S. hospitals, the Nephros DSU system was shown to be effective in reducing waterborne Legionella bacteria to undetectable levels, an effect which was sustained for the 3-month study period.

Nephros has an ongoing collaboration agreement with STERIS Corp. related to its ultrafiltration technology.

In response to a Request For Information (RFI) from the U.S. Army, Nephros submitted its UF-40 ultrafilter for consideration as part of the standard issue hydration pack for soldiers in the field.  Nephros has been informed by the U.S. Army Public Health Command that its UF-40 filter has been validated to meet the military's NSF P248 standard for emergency military operations as a microbiological water purifier.  Nephros believes that its UF-40 filter is the only stand-alone filter to date to have met the performance criteria of the NSF P248 standard without secondary disinfection steps.  The Army has not to date issued a Request For Proposal (RFP), and Nephros has no information regarding when or if an RFP applicable to the UF-40 ultrafilter may be put forth by the U.S. Army.

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. The Nephros DSU, MSU, and SSU are FDA cleared for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Nephros' DSU ultrafilters are being evaluated at several major U.S. medical centers for infection control. Nephros has also developed its UF-40 ultrafilter for purification of drinking water by soldiers in the field.

For more information about Nephros, please visit the company's website at www.nephros.com.

Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements include statements regarding the efficacy and intended use of our technologies under development, 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, 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 realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our other periodic reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC's web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

SOURCE Nephros, Inc.

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