A NEW SORBENT SYSTEM FOR HEMODIALYSIS TREATMENT

ASH MEDICAL SYSTEMS, INC. HAS DEVELOPED A NEW SORBENT-BASED,SINGLE-ACCESS HEMODIALYSIS MACHINE THAT IS SAFE, SIMPLE, AND PORTABLE. THE BIOLOGIC-HD CURRENTLY USES A PLATE DIALYZER TO ACTIVELY PUMP BLOOD WHILE DIALYZING THE BLOOD AND A REDY HISORB COLUMN TO REGENERATE DIALYSATE. PREVIOUS RESEARCH HAS PROVEN THAT A THICK SORBENT SUSPENSION CAN FLOWTHROUGH THE SCREEN SUPPORTS OF THE PLATE DIALYZER, REPLACING THE REDY COLUMN. A SORBENT SUSPENSION IN THE DIALYSATE CAN PRODUCE HIGHER CLEARANCES OF UREMIC TOXINS ANDCAN USE SORBENTS WITH LIGHT DENSITY AND SMALL PARTICLE SIZE,WHICH ARE DIFFICULT TO PUT INTO COLUMNS, SUCH AS ZEOLITES. THE CURRENT PROPOSAL IS TO FURTHER DEVELOP A SORBENT SUSPENSION THAT WILL EFFECTIVELY REMOVE UREMIC TOXINS, RELEASE APPROPRIATE SUBSTANCES, AND MINIMIZE RELEASE OF POTENTIALLY HARMFUL SUBSTANCES. THIS SORBENT SUSPENSION WILL INCLUDE POWDERED CHARCOAL AND MICROCAPSULES, WHICH INCLUDE CALCIUM-SODIUM-LOADED ZEOLITES AND UREASE. IN VITRO TESTS WILL DEMONSTRATE THE SAFETY AND EFFICACY OF THE SORBENT SUSPENSION. IF THESE TESTS ARE POSITIVE, AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) PROPOSAL WILL BE SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION TO ALLOW CLINICAL TRIALS OF THE SORBENT SUSPENSION IN THE BIOLOGIC-HD SYSTEM.