RIVER EDGE, NJ / ACCESSWIRE / October 11, 2016 / Nephros, Inc. (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), is providing a general update on the Company’s activities and guidance for the third quarter of 2016. The Company is also announcing a new HDF cost-effectiveness analysis published in a peer-reviewed journal.
General Corporate Update
In the third quarter of 2016, the Company focused on two primary objectives. First, the Company worked to ramp-up production of its S100 Point-of-Use filters, and assisted distribution partners with the roll-out of this newest product in the Company’s hospital infection control portfolio. The first large production lot was successfully shipped in August. The Company is continuing to ramp up production to meet robust demand.
The second primary objective was to complete the additional analyses requested by the FDA for the both the EndoPur(TM) 10″ cartridge product for dialysis and the HydraGuard(TM) 10″ (formerly called PathoGuard(TM)) cartridge product for hospital infection control. The Company expects to be able to submit the additional information for each product by the end of October. Following the submissions, the Company will focus on validation and release to prepare for the potential commercial launch of the products late in the fourth quarter, pending FDA clearance.
In addition to these primary objectives, the Company continued to work with Vanderbilt to prepare for treatment of patients with HDF beginning in the fourth quarter and made progress toward the development of point-of-entry water filtration systems for use in homes and restaurants.
Third Quarter 2016 Revenue Guidance
The Company expects total revenue for the quarter ending September 30, 2016 to exceed $480,000, an approximately 50% increase over the same period in 2015.
“The third quarter has traditionally been Nephros’ slowest quarter of the year for product sales, reaching only $274,000 in 2015 and $298,000 in 2014,” said Daron Evans, President and Chief Executive Officer of the Nephros. “In addition to our third quarter sales, we generated a strong order backlog which will be fulfilled in the fourth quarter as we continue to ramp-up production. Once our 10″ cartridge product lines receive FDA clearance, we will be well positioned to achieve our goal of being cash flow positive.”
Recently Published Article Supporting the Economic Benefits of HDF Therapy
An article entitled “Cost-effectiveness analysis of online hemodiafiltration versus high-flux hemodialysis” was published in the September 2016 issue of ClinicoEconomics and Outcomes Research. The authors analyzed the cost-effectiveness of online hemodiafiltration (HDF) as a renal replacement therapy for patients with end-stage renal disease, versus traditional high-flux hemodialysis. The analysis utilized published literature and included improved survival data along with health-related Quality of Life (QoL) information as clinical outcome measures to balance against the possibly higher cost of HDF. This analysis showed that the probability of being cost-effective generally exceeded 80%, based on a cost-effectiveness ratio (Cost per Quality-Adjusted Life Years, or QALY) being below the commonly accepted threshold used in making healthcare decisions.
“We are pleased to see this positive analysis showing that the incremental costs of performing HDF can be offset by survival and quality of life improvements,” said Dr. Gregory Collins, Vice President Research and Development of Nephros. “This analysis compared the direct costs of treatment as it related to the QoL benefits, but did not include the potential cost differences from reduced hospitalizations, pharmaceuticals, and other complications, which are key cost components when caring for dialysis patients. We believe the potential benefit of HDF in both patient quality of life and economics could be substantial.”
The full study can be found through the following weblink:
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.
For more information about Nephros, please visit the company’s website atwww.nephros.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the expected timing of regulatory submissions and product clearance, the timing of the commercial release of the Comopany’s 10″ cartridge products, the Company’s third quarter 2016 revenue, the Company’s ability to meet future demand for its products, the Company’s ability to achieve positive cash flow from operations and the timing thereof, the cost-benefit 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.