Sales and Marketing

The Islet Sheet is the most practical therapy for diabetes providing euglycemia without immune suppression drugs. For the diabetic, the daily burden of carefully monitoring food intake, exercise and insulin, along with the ever-present fear of hypoglycemia, will disappear. Life then will be much like life without diabetes. For doctors and diabetes health delivery specialists the costs of ?tight? control, hospitalization, morbidity and mortality associated with diabetes, will all disappear. Health care providers will save money.

Islet Sheet Medical?s product is uniquely and literally alive because it comprises islets of Langerhans that synthesize and secrete insulin, a function of living cells only. The use of the product may require postimplantation patient monitoring and perhaps product upgrades. Sheets will be distributed directly to qualified surgeons. The patient?s diabetes will be monitored and managed before implantation. Careful control after implantation will permit reduction of insulin injections as the sheet accepts the burden of diabetes control. Regular followup will evaluate the sheet?s performance. The decision to perform a sheet implant will be made between the patient, the diabetologist/endocrinologist and the health care provider.

Pricing

As a proprietary product, the Islet Sheet will be priced by the value of the therapy rather than by the cost the manufacture. The current direct annual cost to the health care system averages $20,000 per diabetic. Adding in lost work and premature mortality, the value of a sustained euglycemia is arguably several times that. The most similar therapy, naked islet transplantation, has a total cost of the procedure (excluding physicians? fees, cost of immune suppression drugs, and follow-up) at $100,000.

We anticipate a price for sheets needed for a single implant of approximately $20,000 will be readily accepted by the market.

Margins

Introduction of the Islet Sheet will probably take place in phases. When the device is proven in allograft animal models of diabetes, clinical studies of sheets containing human islets will begin. During this first phase cooperation with human islet transplant centers will be necessary, and the Company will be able to charge for sheet fabrication only. The second phase will see Islet Sheet Medical selling bioartificial pancreases made from xenogeneic islets or cells made through islet expansion or genetic engineering.

Projected direct costs of xenograft Islet Sheet manufacture per patient (incorporating significant economies of scale) are estimated as follows.

Procurement of islets

$3,600

Manufacture of sheet and quality control

$1,800

Post-implantation monitoring

$1,600

Total
$7,000

The margin at a selling price of $20,000 would be 65%. Efficient methods for culturing islets would cost much less.