How temporary or permanent would the implanted artificial kidney be?

Dr. Roy: It’s hard to say prospectively without doing the studies, but we hope that it will be one surgery to implant it, and that should be it. But we also recognize that you have to plan for maintenance or replacement: The filter could get clogged up, or the cells could die.

So, we have thought of a strategy where the artificial kidney gets implanted right underneath the skin. That way, components can be replaced in a minimally invasive procedure, which would probably be performed by a vascular surgeon. We do not anticipate the whole device having to be removed.

Based on our lab studies and what we can project, we think that no maintenance will be needed for at least one year.

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Which patients would be eligible to receive the artificial kidney?

Dr. Roy: Today, 95,000 people are on the wait list for kidney transplants, which are still the gold standard for treating end-stage renal disease. In this country we do about 17,000 or 18,000 transplants per year, meaning that more than 75,000 people who require transplants won’t get one this year.

So, the best candidates for us are probably people who are already on that list, but are low enough that the likelihood of them getting a transplant is not that great. If they are physically able to withstand the surgery for our device, they would qualify.

Where will the artificial kidney fall in terms of cost?

Dr. Roy: A typical dialysis patient today costs Medicare about $85,000 annually, and a transplant patient, after the initial surgery, costs Medicare about $30,000. Most of that $30,000 is spent on immunosuppressant medications to prevent rejection.

Our device will require surgery probably like a transplant surgery, although maybe not as complicated. But the patient will likely not require immunosuppressive drugs because our cells are protected from the patient’s immune system. Maybe our device will cost about $10,000 to $20,000 a year in maintenance. I think if we’re completely successful and enough patients on dialysis receive our device, we could lower the $30 billion Medicare currently spends on patients who have kidney failure to at least half that amount.

How do you expect survival rates to compare?

Dr. Roy: I do feel confident that our device will provide better survival than dialysis. Would it be as good as transplant? Again, prospectively it’s hard to say, but we can hope the survival rates will be closer to those seen with transplants than those seen with dialysis because our device would provide many of the functions of a transplant.