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SOUTH ORANGE, NJ, Oct. 13, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Nephros, Inc. (Nasdaq: NEPH), a commercial-stage firm that develops and sells excessive efficiency water purification merchandise and pathogen detection programs to the medical and industrial markets, as we speak introduced availability of DialyPath™, an assay that estimates endotoxin ranges in dialysis water samples.
Water sampling is mostly required in dialysis clinics to make sure that no waterborne contamination is current. Of specific curiosity are endotoxins, that are gram-negative bacterial fragments that may trigger irritation and different problems in dialysis sufferers. DialyPath is an on-site check that measures endotoxin ranges in about two hours.
DialyPath outcomes correlate extremely (R2>0.95) with knowledge from the limulus amebocyte lysate (LAL) assay, at present the business customary for endotoxin measurement (EU/ml). DialyPath makes use of qPCR know-how to quantify DNA goal segments in a water pattern, that are matched to a DNA section that’s present in all gram-negative micro organism. From these outcomes, DialyPath makes use of proprietary algorithms to estimate the variety of endotoxin models in a dialysis water pattern.
“We’re very excited to launch DialyPath,” stated Kimothy Smith, DVM, PhD, Vice President of Pathogen Detection Techniques at Nephros. “It’s a particularly delicate assay, with a 0.001 EU/ml decrease restrict of quantification (LLOQ), in comparison with an LLOQ of 0.1 EU/ml for many LAL assays.”
Dr. Smith continued, “Water sampling as we speak is essentially carried out at off-site laboratories, sometimes requiring 2-Three days to supply actionable outcomes. By comparability, DialyPath is an on-site check, offering outcomes inside 2 hours. This may enable biomedical engineers to extra shortly diagnose, appropriate and recommission dialysis water therapy programs. ”
DialyPath was designed to ship real-time endotoxin knowledge to biomedical engineers in dialysis clinics and hospitals, who must make choices on dialysis water programs for affected person well-being. With broader market expertise and validation, Nephros believes that DialyPath might change the LAL assay for the routine testing of dialysis water and dialysate. Nephros is at present producing a big knowledge set to validate DialyPath for a variety of on-site circumstances and water samples and plans to publish this knowledge in a peer-reviewed journal sooner or later.
Additionally it is value noting that the LAL assay requires using blood cells from the Atlantic horseshoe crab, which is an endangered species. DialyPath doesn’t require using horseshoe crabs. It makes use of solely supplies from artificial chemistry and bacterial cell tradition extractions.
Nephros is a commercial-stage firm that develops and markets excessive efficiency water purification merchandise and pathogen detection programs for medical and industrial markets.
Nephros ultrafilters are utilized in hospitals, medical clinics, and industrial services to retain micro organism – together with Legionella and different pathogens – and viruses from water, offering an necessary support in an infection management for showers, sinks, and ice machines. Nephros ultrafilters are additionally utilized in dialysis facilities to assist within the elimination of endotoxins and different organic contaminants from water and bicarbonate focus in hemodialysis machines.
Nephros pathogen detection programs, together with the PluraPath™, SequaPath™, and DialyPath™ programs, present knowledge on waterborne organic content material to medical and water high quality professionals. Our merchandise combine Nephros ultrafilters with quantitative polymerase chain response (qPCR) know-how to ship actionable water pathogen data in actual time.
Nephros industrial filters, together with AETHER™ model filters, enhance the style and odor of water, and cut back scale build-up in downstream tools. Nephros and AETHER™ merchandise are used within the well being care, meals service, hospitality, and comfort retailer markets.
For extra details about Nephros, please go to its web site at www.nephros.com.
This launch comprises forward-looking statements which might be topic to varied dangers and uncertainties. Such statements embody statements relating to Nephros’s expectations that its DialyPath product might change the LAL assay for routine testing of dialysis water, its plans to publish knowledge from testing of its DialyPath product, anticipated demand for the DialyPath product, and different statements that aren’t historic info, together with statements that could be accompanied by the phrases “intends,” “could,” “will,” “plans,” “expects,” “anticipates,” “tasks,” “predicts,” “estimates,” “goals,” “believes,” “hopes,” “potential” or related phrases. Precise outcomes might differ materially from these described in these forward-looking statements because of sure components, together with modifications in enterprise, aggressive and financial circumstances, significantly the continued affect of the COVID-19 pandemic on the U.S. financial system, and the provision of financing or different capital when wanted. These and different dangers and uncertainties are detailed in Nephros’s studies filed with the U.S. Securities and Alternate Fee, together with its Annual Report on Type 10-Ok for the yr ended December 31, 2019. Nephros doesn’t undertake any accountability to replace the forward-looking statements on this launch.
Investor Relations Contact:
Kirin Smith, President
PCG Advisory, Inc.
Gotham Communications, LLC
Andy Astor, COO & CFO
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