Full Press Release Details
Receives FDA 510(k) Clearance for HDF Assist Module
First and Only FDA-Cleared Device Available in the United States to Provide Hemodiafiltration
Therapy to Dialysis Patients
ORANGE, NJ, May 17, 2022 - Nephros, Inc. (Nasdaq: NEPH), a leading water technology company providing filtration and pathogen
detection solutions to the medical and commercial markets, today announced that it has received FDA 510(k) clearance for its patented,
second-generation HDF Assist Module. The HDF Assist Module is the first and only device in the United States cleared to provide hemodiafiltration
(HDF) therapy to patients with End-Stage Renal Disease (ESRD).
510(k) clearance is truly a milestone moment for Nephros and Specialty Renal Products (SRP), our majority-owned subsidiary. Nephros was
founded with the goal of providing solutions for patients with ESRD, and today is a big step forward in the process," said Andy
Astor, President and Chief Executive Officer of both Nephros and SRP. "The receipt of FDA clearance for our HDF Assist Module enables
us to provide ESRD patients with a new therapeutic option."
HDF Assist Module is an innovation that offers practitioners the opportunity to use an existing hemodialysis (HD) machine to provide
HDF therapy without the purchase of a new, costly machine," continued Mr. Astor. "SRP's Director of Commercial Operations,
David Lee, an engineer and dialysis nurse with many years of clinical operations responsibility, will lead our initial focus on piloting
the HDF Assist Module within select dialysis clinics."
first goal in any given dialysis clinic will be to support the development of internal procedures for operation of the HDF Assist Module,
and the training of personnel to seamlessly execute those procedures," said Mr. Lee. "Once the procedures are established
and tested within the select clinics, we will then be able to work with additional clinics to roll out HDF as a therapeutic option for
more dialysis patients."
Inc. is a company committed to improving the human relationship with water through leading, accessible technology. We provide innovative
filtration and pathogen detection as part of an integrated approach to water safety that combines science, solutions, and support services.
Nephros products serve the needs of customers within the healthcare and commercial markets, offering both proactive and emergency responses
for water management.
more information about Nephros, please visit nephros.com.
Specialty Renal Products
Renal Products, Inc. (SRP) is a development-stage company focused on the advancement of hemodiafiltration (HDF) technology for patients
with End-Stage Renal Disease (ESRD). SRP is committed to commercializing the second-generation Nephros HDF Assist Module to enable hemodialysis
machines to also provide hemodiafiltration therapy.
release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding
the anticipated market acceptance of the HDF Assist Module, Nephros' and SRP's ability to commercialize the HDF Assist Module,
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 Nephros' and SRP's ability to achieve market acceptance of the HDF Assist Module, SRP's lack of experience
in commercializing technologies, the impact of the ongoing COVID-19 pandemic, uncertainty in clinical outcomes, changes in business,
economic and competitive conditions, the availability of capital when needed, 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' reports filed with the U.S. Securities and Exchange Commission. Nephros does not undertake
any responsibility to update the forward-looking statements in this release.