RIVER EDGE, N.J., Nov. 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 engaged Joseph S. Cervia, M.D. as a strategic consultant.
Joseph S. Cervia, MD, MBA, FACP, FAAP, FIDSA, AAHIVS is Clinical Professor of Medicine and Pediatrics at the Albert Einstein College of Medicine and Hofstra North Shore-LIJ School of Medicine (Division of Infectious Diseases). From 2004 to 2011, he served as Global Medical Director and Senior Vice President for Pall Corporation (NYSE: PLL) where he was responsible for supporting all aspects of the global medical enterprise, including medical and regulatory affairs, research and development, medical marketing and communications, technology assessment, and technical support. A board-certified internist, pediatrician, adult and pediatric infectious diseases and HIV medicine specialist, Dr. Cervia has dedicated much of his career to establishing and leading multi-disciplinary teams in battling infectious diseases, and to education and research in prevention, therapeutics, complicating illnesses, and quality of life issues. He has authored over 100 peer-reviewed articles, chapters, and abstracts; lectures widely; and serves as a consultant to numerous local, national, and international organizations on HIV, infectious diseases, and other health care-related issues. Dr. Cervia earned his B.S. in biology from St. Johns University, his M.D. degree from New York Medical College, and an MBA degree from Regis University. He is a board-certified diplomate in five medical specialties: Internal Medicine, Pediatrics, Adult Infectious Diseases, Pediatric Infectious Diseases and HIV Medicine.
“Nephros has a leading edge line of ultrafiltration products which addresses many important applications in which biological contaminants must be removed from fluid,” said Dr. Cervia. “I look forward to working with Nephros to increase market awareness and adoption of the company’s products.”
“Joseph Cervia is a highly regarded thought leader in the area of infection control,” said Dr. Paul Mieyal, acting CEO of Nephros. “His prior experience as Global Medical Director for Pall Corporation as well as his extensive knowledge of hospital infection control issues will be an invaluable resource for Nephros as the company continues to create value through its ultrafiltration products.”
Nephros Ultrafiltration Products
The Association for the Advancement of Medical Instruments’ (AAMI) adoption of more stringent water purity standards for dialysis applications as well as observational studies showing a significant reduction in required erythropoietin dosing when the Nephros DSU is utilized during dialysis therapy has 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 filters in hospital showers, and the SafeSpout as a convenient endpoint 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. (NYSE: STE) related to its ultrafiltration technology.
Nephros has contracted with the Office of Naval Research to develop an advanced water purification system for military field use. Nephros’s proprietary dual stage cold sterilization ultrafilter will form the basis of the portable system.
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 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 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, 2010, as amended 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.
