Cerco Medical has established a significant intellectual property barrier through its patents, both issued and applied for, as well as numerous trade secrets which will raise an even higher barrier to competitive devices utilizing the same materials or thin-sheet approach to diabetes treatment. This protection will also apply to many potential other uses of alginate in medical products with flat sheet format. This protection is paramount to the Company and receives the highest attention in its operational plans.
Cerco Medical’s key patent (U.S. 6,165,225, issue date December 26, 2000) includes claims which cover all thin-sheet devices with high cell density in the thin sheet format larger than 6mm in diameter. (Note size comparison of 6mm to a "dime").
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6mm disc
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Cerco Medical achieved this broad coverage through a precise IP strategy. Prior art is limited to membrane “sandwiches” in the form of two membranes stretched over a metal ring. In functional terms these devices (called “Boggs chambers”) are limited by widths which are less than 6mm: if larger, the membranes bow or pillow, causing centrally located cells to die. The Islet Sheet can be made in shapes and sizes that vary widely, but consistently have uniform thicknesses in the 0.3 millimeter range.
The patent claims do not specify the types of cells incorporated into the delivery system which means Cerco Medical is not limited to islets, per se, as the sole cellular basis of its products. Cerco Medical is able to utilize its technology to deliver a variety of therapeutic molecules produced by cells.
In addition, the patent claims in the U.S. are not limited by material (e.g., alginate), so thin sheets made from any material are covered. In short, Cerco Medical has a patent monopoly on all workable thin-sheet bio-artificial organs.
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