Nephros Subsidiary Specialty Renal Products and HemoCleanse Announce License Agreement for Dialysate Filtration System

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.