Diabetes mellitus is the sixth leading cause of death by disease in the United States, afflicting approximately 16 million people. Currently, there is no cure. The disease is treated by regular, life-long injections of insulin at a large cost to patients, both economically and psychologically. Among the potential treatments being investigated, the transplantation of human islets seems to have significant advantages and could prevent many diabetic complications. Research to improve the islet isolation process is essential to the goal of metabolic control by islet transplantation. BIOMEC Systems, Inc. is combining its skills in acoustic medical device design and development with the clinical expertise and facilities within the University of Cincinnati's cellular transplantation program to establish an innovative approach to islet isolation. There are two objectives: (1) to establish that a similar islet yield can be achieved with a simplified, existing form of the novel acoustic method and (2) to perform the engineering design and evaluation of the novel system that includes the features to speed pancreas dissociation. Phase II will integrate the outcomes of the two objectives with a limited parametric study to optimize the novel system and its method of use for high islet yield.
The commercialized acoustic systems would initially be marketed to cell transplantation programs for clinical studies, trials and basic research and, as islet transplantation proliferates and the proposed method gains acceptance, to procurement and processing laboratories for the isolation of islets of Langerhans. A method that provides for rapid processing and high-yields from donor pancreases (human, porcine, et cetera) would be of significant clinical use and gain a large share of the available market. While the total market for diabetes therapies includes all 16 million Americans with the disease, the expected available market for the proposed system is based on a more conservative approach (considers only diagnosed cases). BIOMEC expects a base market for the system of 0.52 to 1.04 million patients with 39,900 to 79,800 patients added annually. Therefore, the conservative market base for the proposed system is $65 to $130 million with annual additions of between $5.0 and $10.0 million.
