OCCULOGIX INC. (NASDAQ:RHEO)
OccuLogix, Inc. is an ophthalmic therapeutic company founded to commercialize treatments for eye diseases, including age-related macular degeneration (AMD). The Company's product, the RHEO System, is designed to improve microcirculation in the eye by filtering high-molecular weight proteins and other macromolecules from the patient's plasma. The RHEO Therapy is used to perform Rheopheresis, which OccuLogix refers to under its trade name RHEO System. Rheopheresis is a blood filtration process that removes molecules from plasma. The RHEO System consists of the OctoNova Pump and a disposable treatment set, containing two filters, through which the patient's blood circulates. The RHEO System employs a double filtration apheresis process, whereby a pair of single use blood and plasma filters sequentially separate and partially remove the targeted plasma components. The system removes macromolecules greater than a specified size from the plasma. The RHEO System consists of two components, OctoNova pump and disposable treatment sets. The OctoNova pump is a microprocessor-controlled device used to circulate blood and plasma from the patient through the filters, and back to the patient. The OctoNova pump is complemented by single-use sterilized tubing which creates a closed-loop system. Blood is pumped through the tubing with small gear-like sprockets that create a peristaltic action in the tube similar to that which occurs in the Company's intestines. The smooth-edged teeth of the sprockets press against the outside surface of the tube pushing the blood along the length of the tube as the wheels turn all at the same rate and direction. No blood ever leaves the closed-loop system. The OctoNova pump was developed in the 1990s by Diamed and licensed to OccuLogix in 2002. The Company is seeking United States Food and Drug Administration (FDA) approval of the OctoNova pump as part of the RHEO System PMA. Disposable treatment sets consist of the tubing and two filters, the Plasmaflo filter and the Rheofilter. One treatment set is used for each treatment undertaken by the patient. The Plasmaflo filter performs the initial function of separating the blood cells from the plasma. The Rheofilter is a single-use, hollow-fiber nanopore membrane, which is used to filter specific high molecular weight proteins and other macromolecules from the plasma. Following this, the filtered plasma is reconstituted with the blood cells and returned into the patient. The tubing and the filters are easily disposed after each patient procedure by the administering nurse, providing the Company with a recurring source of revenue. The Rheofilter was developed in the early 1980s by Asahi Medical. OccuLogix is seeking FDA approval of the tubing and two filters as part of the RHEO System PMA. The Company is working to complete the PMA with Asahi Medical, and upon FDA approval of the PMA it has an agreement to transfer this FDA approval to them. Each RHEO Therapy procedure takes between two and four hours to complete and begins by placing one intravenous line in each forearm of the patient. Blood is pumped from a large vein in one arm and circulated through the filtration system where the whole blood is separated from the plasma by the Plasmaflo filter. The plasma is filtered through the Rheofilter, which filters high-molecular weight proteins and other macromolecules from the patient's plasma. The plasma is then remixed with the blood and is returned to the patient intravenously. Only approximately 1.25 pints of blood are outside the patient's body and at all times blood remains in a sterile closed circuit. Throughout the RHEO Therapy procedure, the attending nurse monitors the blood pressure, heart rate, oxygen saturation, cardiac rhythm and activated clotting time of the patient. The attending nurse also gauges the flow rates, temperature and pressures of the filters. No blood products or medications are added, other than a small amount of heparin to prevent clotting in the tubing system. The initial course of eight procedures of RHEO Therapy given
As Of: 12/31 16:00 ET
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