Nephros Receives Approval to Market Dual Stage Ultrafilters in Canada
Filters are engineered for use in water purification for dialysis procedures
Nephros Inc. announced that on May 10 it received approval from the Therapeutic Products Directorate of Health Canada, the Canadian health regulatory agency, to market its Dual Stage Ultrafilters (DSU) in Canada to filter out biological contaminants from water and bicarbonate solution used in hemodialysis procedures.
"Nephros is pleased to have received approval from the Therapeutic Products Directorate to market its Dual Stage Ultrafilters in Canada," said Dr. Paul Mieyal, acting CEO of Nephros Inc. "Recent data have shown that the Nephros DSU, when used as part of the water purification system for dialysis systems, may reduce the required dosage of erythropoietin stimulating agents, which we believe will provide a unique benefit to patients. We are proud to have the opportunity to introduce this important product to dialysis patients in Canada."
According to the Canadian Organ Replacement Registry, in 2009 there were approximately 38,000 patients with end-stage renal disease in Canada.
The Nephros DSU is an FDA-cleared device for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Within the U.S., there are approximately 4,500 clinics providing more than 50 million dialysis treatments to 350,000 patients annually. To perform hemodialysis, ultrapure water is crucial to the production of dialysate. Dialysis clinics have water purification systems; however, microbial contaminants can originate from the water treatment system, the water distribution loop or the dialysate concentrates. The Nephros DSU filters out substances down to the 0.005-micron level and addresses dialysate contamination at crucial points: after the reverse osmosis module and at the dialysis machine entrance from the water distribution loop. The DSU filter can be used as the last step in the water purification process to ensure that ultrapure water is used for dialysis procedures.