RIVER EDGE, NJ, August 25, 2016 /Issuer Direct/ — Nephros, Inc. (OTCQB:NEPH) (the “Company”), 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 (HD) machine for the treatment of patients with End Stage Renal Disease (ESRD), announced today that it has signed an agreement to enable a Vanderbilt Dialysis Clinic to offer hemodiafiltration (HDF) to patients.
The agreement provides Vanderbilt with the Company’s OLp?r H2H Hemodiafiltration System, dialysis supplies and service support to facilitate HDF treatment. The OLp?r H2H Hemodiafiltration System is the only FDA 510(k) cleared medical device that enables nephrologists to provide HDF treatment to patients with ESRD. It is expected that Vanderbilt will be able to begin transferring selected and qualified patients over to HDF therapy in the coming months. These efforts will be lead by Dr. Jamie P. Dwyer, Associate Professor of Medicine in the Nephrology and Hypertension Division at Vanderbilt University School of Medicine and Co-Director of the Vanderbilt Nephrology Trials Center. Dr. Dwyer currently serves as Medical Director of the Vanderbilt Dialysis Clinic chosen to offer HDF treatment.
The Vanderbilt Nephrologists are globally known and respected for their on-going efforts to understand and improve the lives of their patients,” said Monet Carnahan, Director of Dialysis Products for Nephros. “And with Dr. Dwyer’s commitment to expand and explore innovative ESRD care, we look forward to supporting his effort to improve patient well-being and quality of life, and to increase the collective understanding of benefits that HDF therapy could provide to US patients.”
“Is hemodiafiltration ready for broader use?” (http://www.kidney-international.org/article/S0085-2538(15)61003-1/pdf), written by Dr. Thomas Golper, Professor of Medicine in the Nephrology and Hypertension Division at Vanderbilt University School of Medicine and published in Kidney International in 2015, was a call to action to better understand how HDF can be integrated into the US dialysis treatment paradigm. The article stated that HDF “removes uremic species more broadly than is achieved by diffusion dialysis, perhaps explaining its better outcome profile.” While Dr. Golper provides some confounding data in this article that makes a direct comparison between the US and European dialysis outcomes difficulty, the article observes that “survival of hemodialysis patients in Europe has consistently been superior to that observed in the United States.”
About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters, as well as a hemodiafiltration system for the treatment of patients with End Stage Renal Disease. Nephros filters or ultrafilters are used primarily in medical applications in various settings. These ultrafilters are used by dialysis centers for assisting in the added removal of biological contaminants from the water and bicarbonate concentrate supplied to hemodialysis machines and the patients. Additionally, Nephros ultrafilters are used in hospitals and medical clinics for added protection in retaining bacteria (i.e. Legionella, Pseudomonas), virus and endotoxin from water. These ultrafilters provide barriers that assist in improving infection control with showers, sinks, and ice machines.
Data from various European Clinical Trials show the following benefits of HDF therapy:
- Decreased patient Mortality
- Improved patient Quality of Life (QOL)
- Reduction in hospitalizations and length of stay
- Improved Anemia Management
- Enhanced clearance of middle and large molecular weight toxins
- Reduction in inflammation and oxidative stress
- Reduction in the occurrence of dialysis-related amyloidosis
Nephros has not performed clinical trials of sufficient size to validate these benefits with its HDF system in the US treatment setting.
For more information about Nephros, please visit the company’s website at www.nephros.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the benefits of HDF in dialysis treatment 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 uncertainty in clinical outcomes, potential delays in the regulatory approval process, changes in business, economic and competitive conditions, the availability of capital when needed, our dependence on third party manufacturers and researchers, regulatory reforms, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Nephros Inc.’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, 2015. Nephros, Inc. does not undertake any responsibility to update the forward-looking statements in this release.
PCG Advisory Group
Kirin M. Smith, Chief Operating Officer