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
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
HDF Assist Module Patent
On
“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
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
Investor Relations Contact:
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Company Contact:
(201) 345-0824
andy@nephros.com
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