Chronic Kidney Disease
Chronic kidney disease (CKD) is the gradual and usually permanent loss of kidney function. According to the National Kidney Foundation, there are over 40 million adults in the U.S. with CKD with an estimated 31 million un-diagnosed and at increased risk, including African-Americans, Latinos and American Indians. CKD consists of five stages of increasing severity. The fifth stage is end-stage renal disease (ESRD). According to industry research, there were approx. 508,570 ESRD patients receiving dialysis in the U. S. early 2016 and 2.82 million total worldwide, growing 5-7% annually. The company estimates the expected Triferic U.S. addressable iron market at commercial launch to be $300-600 million and $1+ billion world-wide. All patients with ESRD will need dialysis or kidney transplantation to sustain life.
A kidney transplant often will give an ESRD patient the most nearly normal life. This is a surgical procedure where a single healthy kidney replaces a permanently damaged kidney within the patient's body. Best results are seen from a donor who is a living relative whose tissues closely match those of the recipient. Transplants from cadaver donors (individuals who have died) also are frequently successful. However, there are approximately 30,000 Americans waiting for kidney transplants. The wait can be anywhere from a few weeks to two years or more. Unfortunately, because of a shortage of suitable donors, less than half that number will receive transplants.
Even with a successful transplant operation, 10 percent of transplant patients experience rejection of the donated kidney within the first year and there is a 25 percent rejection rate in three years. To prevent rejection, strong medication will be required for the rest of the patient's life.
More than 50 percent of patients with ESRD do not meet the requirements for a successful kidney transplant. This includes most people in the elderly population, and those with multiple illnesses like heart disease, history of chronic infection, cancer or decreased immune function. For these patients, kidney function may be replaced by one of two methods of treatment - either peritoneal dialysis or hemodialysis.