Source: Nephros, Inc.-August 14, 2018
Pioneering HemoCleanse CEO to Join Specialty Renal Products Board of Directors
Specialty
Renal Products, Inc. (SRP), a subsidiary of Nephros, Inc. (OTCQB:NEPH),
a medical device company that develops and sells a hemodiafiltration
system for the treatment of patients with End Stage Renal Disease
(ESRD), and HemoCleanse Technologies, LLC, (HCT) a medical device
company focused on the development of sorbent products to improve
outcomes for patients on hemodialysis (HD), announced today that they
have entered into an exclusive agreement to develop and commercialize a
dialysate regeneration and filtration system.
Under
the agreement, SRP has obtained the worldwide development and
commercialization rights to patents, know-how and improvements relating
to carbon-based sorbent technology intended for use in the field of the
treatment of renal disease. HCT retains the commercialization rights to
the carbon-based sorbent technology in fields outside of the treatment
of renal disease. In addition, SRP has agreed to be the manufacturer of
record for licensors of the technology outside of the field of the
treatment of renal disease. Additional terms were not disclosed.
SRP
intends to develop and market a filtration system for use in
conjunction with the disposable tubing circuit sets used in treatments
that provide continuous renal replacement therapy (CRRT). The system
will apply to patients who present in the intensive care unit with acute
kidney injury (AKI). CRRT allows the clinician the ability to manage
unstable AKI patients by offering slower ultrafiltration and solute
removal. Some advantages with performing CRRT continuously (24 hours per
day) include improved hemodynamic tolerance and more control over the
total volumes given and removed from unstable AKI patients.
Additionally,
Dr. Stephen Ash, CEO and Medical Director of HCT, has agreed to join
the board of directors of SRP. Dr. Ash has been a pioneer and innovation
leader in the nephrology field for over 30 years. Dr. Ash is a
practicing Nephrologist at Indiana University Health Arnett in
Lafayette, Indiana. In addition to his role at HCT, Dr. Ash is Chairman
of the Board of Ash Access Technology and co-founder of several spin-off
biotechnology firms. He has a long history of research and product
development in the field of sorbents, resulting in devices for the
treatment of kidney failure (Allient™ by Renal Solutions) and liver
failure (Liver Dialysis by HemoTherapies). For hyperkalemia, he was
instrumental in development of an orally ingested sorbent (ZS-9 by ZS
Pharma, now part of Astra Zeneca). Dr. Ash has also invented many new
catheters for dialysis access, including the Ash Split Cath®,
CentrosFLO® and Advantage™ PD Catheter.
“This is
an exciting opportunity for SRP and we look forward to working with Dr.
Ash to bring this promising therapy to market,” said Monet Carnahan,
R.N., Director of Dialysis Products at Nephros. “SRP is focused on
improving the lives of patients with renal disease, and this technology
provides an innovative solution that may improve continuous veno-venous
hemodialysis therapy, both in terms of ease-of-use for nurses and
improved patient outcomes.”
“I have been
impressed with the Nephros team and believe they are the right partners
to develop and commercialize the dialysate regeneration and filtration
system,” said Dr. Stephen Ash, co-founder of HemoCleanse Technologies.
“In addition, I am excited to join the SRP board, and help bring
additional therapies to patients with renal disease. SRP’s
hemodiafiltration system has a unique opportunity to potentially change
the quality of life and outcomes for some ESRD patients.”
CRRT Background
Technologically,
CRRT is different from standard HD in that CRRT devices rely on bags of
dialysate to provide the treatment, while HD devices generate dialysate
in real-time from ultrapure water and dialysate concentrate.
Achieving
the treatment goal for AKI without causing the patient to become
hemodynamically unstable requires the removal of the water and toxins to
be much slower, and to take place over an extended period of time. One
treatment modality of CRRT is continuous veno-venous hemodialysis
(CVVHD), which provides continuous therapy, maximizes the amount of
ultrafiltration possible per day, and removes middle molecules (similar
to hemodiafiltration). The disadvantages of CVVHD include the labor and
cost associated with replacing the dialysate bag up to 8 times per day
to provide up to 40 liters of fresh fluid, the low dialysate flow rate,
and the excessive removal of small molecules, which can require hospital
pharmacies to add supplements to the dialysate bags prior to use,
further increasing the cost of treatment. SRP and HCT believe that a
carbon-based filtration system inserted into the disposable CVVHD
circuit may enable the regeneration of patient’s sterile dialysate,
reducing the overall total sterile fluid usage. In addition, by removing
more uremic toxins and middle molecules, the system may improve the
clinical response seen with patients and allow for higher dialysate flow
rates.
About Specialty Renal Products, Inc. and Nephros, Inc.
Specialty
Renal Products, a subsidiary of Nephros, is focused on the development
of medical device products for patients with renal disease, including a
hemodiafiltration system for the treatment of patients with ESRD.
Nephros
is a commercial stage medical device company that develops and sells
high performance liquid purification filters. Nephros filters – known as
ultrafilters – are used primarily in medical applications in various
settings. These ultrafilters are used by dialysis centers for assisting
in the added removal of biological contaminants from the water and
bicarbonate concentrate supplied to hemodialysis machines and the
patients. Additionally, Nephros ultrafilters are used in hospitals and
medical clinics for added protection in retaining bacteria (i.e.
Legionella, Pseudomonas), virus and endotoxin from water. These
ultrafilters provide barriers that assist in improving infection control
with showers, sinks, and ice machines.
For more information about Nephros, please visit its website at www.nephros.com.