Benzinga | Jan 4, 2021 07:36AM EST

Nephros Provides Year-End Technology Update

HDF Assist Device Complete; Special 510(k) to be Filed in Early 2021

Nephros Granted Patent Covering Technology in HDF Assist Module

Nephros Expands EndoPur(r) and S100 Filter Labels to Include Heat Disinfection

SOUTH ORANGE, NJ, Jan. 04, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Nephros, Inc. (NASDAQ:NEPH), a commercial-stage company ("Nephros") that develops and sells high performance water purification products and pathogen detection systems to the medical and commercial markets, today provides an update to the second-generation HDF Assist Module program ("HDF2") being developed and commercialized through its majority-owned subsidiary, Specialty Renal Products Inc. ("SRP"), announces the granting of a patent that covers technology utilized in HDF2, and announces expanded heat disinfection product capabilities.

HDF Assist Module Status Update

"We are very pleased to announce today that the HDF2 technology is now complete, after delays in prior quarters," said Daron Evans, President of SRP. "As part of our commercial launch preparations, however, we have decided to postpone the HDF2 Special 510(k) filing a few weeks into the new year. We are scaling-up our supply chain and manufacturing capability to support expected future growth and believe that our filing will be stronger if we include details on these manufacturing plans in our submission."

Mr. Evans continued, "As a result of this decision, we will miss our self-declared deadline of filing by the end of 2020, a decision we do not take lightly. However, we do not believe this delay will materially impact either near-term revenue potential or the strategic potential of HDF2, due to the continuing impact of the COVID-19 pandemic on the dialysis industry. We believe that a commercial launch of HDF2 into dialysis clinics will not be possible until after the nation is mostly through the COVID-19 vaccination process, in mid-2021 at the earliest."

HDF Assist Module Patent

On November 3, 2020, Nephros was officially granted US Patent 10,821,216: Method and Apparatus for Hemodiafiltration Module for use with a Dialysis Machine. The patent covers certain aspects of the circuit used to generate substitution fluid from the dialysate generated by a hemodialysis machine.

"We are pleased to have been awarded a patent on our HDF2 design, providing protection on our module and disposable tube set until 2038," said Mr. Evans. "We believe that this patent also has applicability in the generation of substitution fluid for other extracorporeal circuits which may utilize substitution fluid."