Nephros Announces First Commercial Placement of its FDA-Cleared On-line Mid-dilution Hemodiafiltration System in the United States
RIVER EDGE, N.J., May 13, 2014 /PRNewswire/ -- Nephros, Inc. (OTCQB: 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 the treatment of chronic renal failure patients, announced today the first commercial use of its hemodiafiltration ("HDF") system in the United States.
As announced in a separate press release today, DaVita Kidney Care, a division of DaVita HealthCare Partners Inc., is now delivering HDF treatments to select patients in Colorado Springs as part of a six-month trial program. This marks the first commercial delivery of on-line HDF via the Nephros HDF system in the United States. The HDF system is comprised of Nephros' FDA-cleared OLpur MD220 Hemodiafilter and Nephros' OLpur H2H Hemodiafiltration Module. Nephros' OLpur MD220 Hemodiafilter is designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Hemodiafiltration technology. Nephros's OLpur H2H Hemodiafiltration Module is indicated for use with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure.
"Nephros offers the only FDA cleared on-line HDF therapy available in the U.S., and I am proud that select patients in this country are now being treated with this important therapy," said John C. Houghton, President & CEO of Nephros, Inc. "Today's announcement represents the first product placement in Nephros' ongoing limited launch of its HDF system. In parallel, Nephros continues to evaluate opportunities to leverage the resources of a strategic partner to most effectively expand into the broader market."
About Chronic Kidney Disease
26 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 this, 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 commonly practiced in Europe but the Nephros HDF system is the only FDA cleared device available in the U.S.
About Nephros, Inc.
Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters. Our filters, which we call ultrafilters, are primarily used in dialysis centers for the removal of biological contaminants from water, bicarbonate concentrate and/or blood.
We were 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). We have extended our filtration technologies to meet the demand for liquid purification in other areas, in particular water purification.
Presently, we offer ultrafilters for sale to customers in four markets:
- Dialysis Centers - Water/Bicarbonate: Filtration of water or bicarbonate concentrate used in hemodialysis devices
- Dialysis Centers - Blood: Clearance of toxins from blood using an alternative method to HD in patients with chronic renal failure
- Military and Outdoor Recreation: Highly compact, individual water purification devices used by soldiers and backpackers to produce drinking water in the field
- Commercial Facilities including Hospitals: Filtration of water for drinking and washing
For more information about Nephros, please visit the company's website at www.nephros.com.
Certain statements in this press release constitute "forward-looking statements". 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. 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, but are not limited to, the risks that:
- we may not be able to find a strategic partner to successfully market our HDF system;
- our HDF system may not be accepted by patients or health care providers in the U.S. marketplace;
- we may not be able to continue as a going concern;
- the voluntary recalls of point of use and DSU in-line ultrafilters used in hospital water treatment applications announced on October 30, 2013 and the related circumstances could subject us to claims or proceedings by consumers, the FDA or other regulatory authorities which may adversely impact our sales and revenues;
- we face significant challenges in obtaining market acceptance of our products, which could adversely affect our potential sales and revenues;
- there are product-related deaths or serious injuries or product malfunctions, which could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products;
- we face potential liability associated with the production, marketing and sale of our products, and/or the expense of defending against claims of product liability, could materially deplete our assets and generate negative publicity which could impair our reputation;
- to the extent our products or marketing materials are found to violate any provisions of the FDC Act or any other statutes or regulations then we could be subject to enforcement actions by the FDA or other governmental agencies;
- 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 have sufficient capital to successfully implement our business plan;
- we may not be able to effectively market our products;
- we may not be able to sell our water filtration products or chronic renal failure therapy products at competitive prices or profitably;
- we may encounter problems with our suppliers, manufacturers and distributors;
- we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures;
- we may not obtain appropriate or necessary regulatory approvals to achieve our business plan;
- 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 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 key geographic markets.
More detailed information about the company 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, 2013 and our other periodic reports filed with the SEC. We urge you 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.