FDA Gives Thumbs Up to Water Cleansing System (OTC:NEPH) - SmallCap Network Print

Congratulations are in order for management and staff and long-term shareholders of Nephros, Inc. (OTC:NEPH) who have brought an important treatment on-line for people afflicted with kidney disease.

Nephros, is a medical device company that makes and sells filtration products for therapeutic applications, infection control, and water purification. The Company’s hemodiafiltration (HDF), system is designed for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. 

The Nephros HDF system removes a range of substances known as middle molecules. These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. 

Nephros ESRD products are sold and distributed throughout Europe and are being used in over 50 clinics in Europe.

And now it’s onward to opening up the market in the U.S. 

The Company announced yesterday it has received 510(k) clearance from the Food and Drug Administration ("FDA") to market its Hemodiafiltration ("HDF") system for the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards in the United States.

"HDF represents an alternative treatment option for chronic renal failure, and I am excited that patients in the United States will now have the opportunity to be treated with this important therapy," said Leonard Stern, M.D., Medical Director at Columbia University Dialysis Center, and Associate Clinical Professor of Medicine, Columbia University, College of Physician and Surgeons. 

"Nephros can now offer the only on-line HDF therapy available in the U.S.," said John C. Houghton, President and CEO of Nephros, Inc. "Nephros will first pursue a limited launch of its HDF system before expanding into the broader market. In parallel, Nephros will evaluate opportunities to leverage the resources of a strategic partner to most effectively address the market."

Not just another mouthwash; I really like bio-tech when companies bring an “Important Treatment Device” to market that will make a big difference in the lives of patients. That’s what NEPH has done.

Shares are trading today on the news at $1.70. 

I haven’t, don’t, and do not intend on holding any of the companies mentioned in this article.

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