Islet Technology, Inc. (ITI) is a biomedical company focused on the processing and purification of insulin-producing islets to be supplied to transplant centers, eventually worldwide. Our core technologies are islet isolation and encapsulation. We are committed to seeing a cure for diabetes happen in our lifetimes.
ITI has developed a valuable intellectual property portfolio covering both islet isolation and encapsulation, which we believe will provide the protection needed to effectively commercialize our islet processing services.
Islet transplantation is currently in the final phase of human clinical trials begun in the year 2000. For the majority of participants in the trials, the need for externally administered insulin has either been eliminated or greatly reduced, making them insulin self-sufficient. In 2004, it is expected that data from these trials will be submitted to the FDA for approval in order to begin the process of making islet transplants more broadly available.
In preparation for commercialization, ITI is in the process of establishing an islet processing center in the Minneapolis/St. Paul area of Minnesota. Once this facility is approved, ITI will be able to supply islets to transplant centers in the U.S.
Much work needs to be done in many areas to ensure the availability of islet transplants. Fortunately on the reimbursement front, the recently-passed Medicare Prescription Drug Act established an important precedent by covering islet transplants within clinical trials involving Medicare patients with end stage renal disease. Private insurance companies look to Medicare for leadership in defining new treatments to be covered, so this Medicare study is an important milestone.
Islet transplantation will grow as the source of islets expands. ITI expects that islet supply will progress from the current limited supply of deceased donors to include living donors (of partial pancreata), and eventually islets harvested from pigs - a virtually unlimited source. ITI's processing facilities will be able to handle the isolation of islets from all of these sources.
When ITI's encapsulation technology is introduced in clinical trials, islets will also be encapsulated at ITI's processing center. Encapsulation involves coating islets with Algi-pure, our proprietary biocompatible material designed to protect islets from attack by the body's immune system. Encapsulation is expected to eliminate or greatly reduce the need for the transplant recipient to take immunosuppressive drugs.
