Nephros Provides Year-End Technology Update, Including HDF Program Status

Rhea-AI Summary

Nephros (NASDAQ: NEPH) has completed its second-generation HDF Assist Module (HDF2) technology and will file a Special 510(k) with the FDA in early 2021, delaying its original timeline. The company has also been granted a patent for the HDF2 design, which will protect its technology until 2038. Additionally, Nephros has enhanced the EndoPur and S100 product lines to withstand heat disinfection, potentially doubling their market reach. Nephros anticipates that commercial launches for the HDF2 module will occur after COVID-19 vaccinations are largely completed.

Positive

• Completion of HDF2 technology enhances product offerings.
• Patent granted for HDF2 design, protecting technology until 2038.
• Expansion of heat disinfection capabilities potentially doubles market addressability for EndoPur and S100 product lines.

Negative

• Delay in filing the Special 510(k) could stall product launch.
• COVID-19 pandemic continues to hinder dialysis industry growth.

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® 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.”

EndoPur® and S100 Heat Disinfection

The EndoPur product line was launched in 2019 to provide ultrafiltration to large loop dialysis clinic water systems. At the time of launch, Nephros validated the product only for cold-water systems that use chemicals for routine water line disinfection. Nephros announced today that we have updated the EndoPur product to withstand routine heat disinfection up to 85ºC (185ºF). Since cold-water disinfection is used in less than half of dialysis clinics, this product update has the potential to double the addressable market for these filtration solutions.

Nephros announced today that the S100 product line has also been validated for heat disinfection. S100 filters provide protection from legionella and other harmful waterborne pathogens at sinks and showers. At hospitals and other medical facilities, they are used to retain these waterborne pathogens and to purify water used for washing and drinking. Hot water lines are particularly susceptible to pathogen growth because heat reduces chlorine levels, which otherwise provide chemical prevention from bacterial growth. By validating heat disinfection on our S100 product line, Nephros provides additional confidence to customers that Nephros products withstand the rigors of the real-world environment, including heat disinfection.

About Nephros

Nephros is a commercial-stage company that develops and markets high performance water purification products and pathogen detection systems for medical and commercial markets.

Nephros ultrafilters are used in hospitals, medical clinics, and commercial facilities to retain bacteria – including Legionella and other pathogens – and viruses from water, providing an important aid in infection control for showers, sinks, and ice machines. Nephros ultrafilters are also used in dialysis centers to aid in the removal of endotoxins and other biological contaminants from water and bicarbonate concentrate in hemodialysis machines.

Nephros pathogen detection systems, including the PluraPath™, SequaPath™, and DialyPath™ systems, provide data on waterborne biological content to medical and water quality professionals. Our products integrate Nephros ultrafilters with quantitative polymerase chain reaction (qPCR) technology to deliver actionable water pathogen information in real time.

Nephros commercial filters, including AETHER™ brand filters, improve the taste and odor of water, and reduce scale build-up in downstream equipment. Nephros and AETHER™ products are used in the health care, food service, hospitality, and convenience store markets.

For more information about Nephros, please visit its website at www.nephros.com.

About Specialty Renal Products

Specialty Renal Products, a majority-owned subsidiary of Nephros, is a development-stage company that intends to commercialize the second-generation HDF Assist Module to enable hemodialysis machines to also provide hemodiafiltration therapy.

Forward-Looking Statements

This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the timing for Nephros’s submission of the FDA Special 510(k) filing and subsequent launch of HDF2, the expected benefits of Nephros’s patents, the expected benefits of heat validation for the EndoPur and S100 product lines, and other statements that are not historical facts, including statements that 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 delays in receipt of required regulatory approvals, lower customer acceptance of new products than otherwise expected, changes in business, competitive and economic conditions, particularly the continued impact of the COVID-19 pandemic on the U.S. economy, and the availability of financing or other capital when needed. These and other risks and uncertainties are detailed in Nephros’s reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019. Nephros does not undertake any responsibility to update the forward-looking statements in this release.

Investor Relations Contact:
Kirin Smith, President
PCG Advisory, Inc.
(646) 863-6519
ksmith@pcgadvisory.com

Company Contact:
Andy Astor, CEO
Nephros, Inc.
(201) 345-0824
andy@nephros.com

FAQ

What is the status of Nephros's HDF Assist Module (NEPH)?

Nephros has completed its HDF2 technology and plans to file a Special 510(k) with the FDA in early 2021.

What patent has Nephros been granted?

Nephros was granted US Patent 10,821,216 for its HDF2 technology, which protects its design until 2038.

How has Nephros expanded its product capabilities?

Nephros has updated its EndoPur and S100 product lines to include heat disinfection, potentially doubling market opportunities.

What impact will COVID-19 have on Nephros's product launch?

Nephros believes the COVID-19 pandemic will delay the commercial launch of HDF2 until after vaccinations are largely completed.