We plan to make the IAK-1 available worldwide.
We estimate that human trials will begin in approximately 5-6 years.
We estimate that it will take about 1 ½ – 2 years before animal trails begin. Before animal trials take place the IAK-1 will need further development and testing. Upon completion and before animal trials begin; the IAK-1 implantable artificial kidney prototype will be upgraded to commercial medical standards that meet FDA requirements. Animal trials will take approximately one year to complete.
We are focusing our design efforts explicitly on the ion, water, and waste removal functions of the kidney. The kidney also makes 1,25 vitaminD and erythropoietin. These 2 hormones will be administered as needed in the clinic as they are currently to patients on dialysis.
No. The IAK-1 will be made from materials that the body will not reject.
The cost has not yet been determined.
In the United States, we believe that the U.S. government will get involved since the IAK-1 could reduce dialysis expenditures by Medicare significantly. In other countries insurance coverage may or may not be available. We will encourage other governments to address this issue and work with them to implement approaches that will reduce the cost to patients.
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