Nephros, Inc., a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration (HDF) system for use with a hemodialysis machine for the treatment of patients with end stage renal disease, announces the release of the SSUmini, a smaller version of its SSU-D medical device.
The SSUmini was developed as a compact, economical solution to provide hemodialysis quality water as a polish filter for smaller, portable reverse osmosis (“RO”) systems and to provide hemodialysis quality bicarbonate concentrate for dialysis clinics with centralized bicarbonate systems. For low-flow rate situations, the SSUmini can provide protection from bacteria, viruses and endotoxins for up to 12 months. The SSUmini is a medical device with U.S. Food and Drug Administration (“FDA”) 510(k) clearance. Details on the SSUmini can be found at www.nephros.com/dialysis.
The SSU-10 is also now available. The SSU-10 is ideal as a polish filter for smaller RO systems, either on the laboratory benchtop or in the home setting under the sink. The SSU-10 is not a medical device.
S100 510(k) Update
The Company filed for 510(k) clearance for its S100 Point of Use microfilter with the FDA in late October 2015. In late December 2015, the FDA requested additional information. On March 8, 2016, the Company submitted a package to the FDA with supplemental information. Pending FDA clearance, the Company aims to launch the S100 in the second quarter of 2016.