Nephroshas received approval from the Therapeutic Products Directorate of Health Canada, the Canadian health regulatory agency, to market its Dual Stage Ultrafilters (DSU).
The Nephros DSU is an FDA cleared device for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.
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.
The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins.
Nephros CEO Paul Mieya said recent data have shown that the Nephros DSU, when used as part of the water purification system for dialysis systems, reduces the required dosage of erythropoietin stimulating agents, which they believe will provide benefits to patients.