Posts
Nephros, Inc. (NEPH), a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration system for use with a hemodialysis machine for the treatment of chronic renal failure patients, announced today that the Renal Research Institute (“RRI”) is conducting an evaluation of the company’s hemodiafiltration (“HDF”) system.
The Nephros HDF system is comprised of Nephros’ patented OLpur MD220 Mid-Dilution Hemodiafilter and OLpur H2H Hemodiafiltration Module. The module is designed for use with a standard hemodialysis machine to enable hemodiafiltration treatment of patients with chronic renal failure.
“RRI is a recognized leader in evaluating new technologies for dialysis practice,” stated Dr. Paul Mieyal, acting CEO of Nephros. “We are gaining valuable insights and feedback from RRI’s ongoing product evaluation as Nephros continues to explore all opportunities to make this important therapy broadly available to patients in this country. Evaluations by sophisticated partners such as RRI are helping us to define our best path forward.”
Paul M. Zabetakis, MD, President of RRI, noted that “since its inception in 1997, RRI has served as a platform for research on innovative technologies and novel clinical approaches aimed at improving the lives of patients on dialysis. We look forward to participating in a thorough evaluation of hemodiafiltration and the Nephros HDF system.”
About Chronic Kidney Disease
Twenty-six million American adults have Chronic Kidney Disease (“CKD”) and millions of others are at increased risk. CKD is a progressive disease which ultimately leads to kidney failure. There are more than half a million patients whose kidneys have failed, requiring them to seek treatment. Of these patients, approximately 370,000 are receiving hemodialysis and this number is growing year on year. In 2011, the total medical care costs for Chronic Renal Failure reached an estimated $49.2 billion. On-line HDF represents an alternative treatment option for chronic renal failure with potential advantages over standard hemodialysis. On-line HDF is practiced in certain countries outside the U.S.; however, the Nephros HDF system is the only FDA cleared device currently available in the U.S.
About RRI
Renal Research Institute (RRI) was established in 1997 as a research division of Fresenius Medical Care AG & Co. KGaA. It is an administratively distinct institution which collaborates with a select group of US based dialysis facilities with strong ties to academic research centers. RRI trains research fellows from countries around the world in kidney disease-related clinical research. Its research spans a full spectrum of interests from molecular biology, clinical research, and pharmaceutical trials to epidemiology. The network of international collaborators has made it a global research institution with ties to Europe, Asia, Central and South America and Africa. RRI’s primary goal is to produce measurable improvements in patient outcomes by building on a solid foundation of clinical research in nephrology. RRI evaluates the development and application of new technology to enhance the quality of patient care.
About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters. Its filters, which it calls ultrafilters, are primarily used in dialysis centers for the removal of biological contaminants from water, bicarbonate concentrate and/or blood.
Nephros was founded in 1997 by healthcare professionals affiliated with Columbia University Medical Center/New York-Presbyterian Hospital to develop and commercialize an alternative method to hemodialysis (HD). The company has extended its filtration technologies to meet the demand for liquid purification in other areas, in particular water purification.
For more information about Nephros and its products, please visit the company’s website at www.nephros.com.
Forward-Looking Statements
This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the ongoing development and evaluation of Nephros’ HDF system and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Nephros Inc.’s or Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission, including with respect to Nephros, its Annual Report on Form 10-K for the year ended December 31, 2013. Nephros, Inc. and Fresenius Medical Care AG & Co. KGaA, together or separately, do not undertake any responsibility to update the forward-looking statements in this release.
Contact:
- See more at: PCG Advisory