Advanced Medical Isotope corp.
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www.isotopeworld.com
Advanced Medical Isotope Corporation, a late stage development company, engages primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications. The company focuses on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The company engages in the development of other medical isotopes for therapeutic and diagnostic purposes and engages in limited operations consisting of the operation of a nuclear accelerator and the sales of third party isotopes. The company’s proton linear accelerator is designed to replace large and cyclotron systems with significant infrastructure and utility requirements, such as electrical and air-handling, for the production of positron emitting isotopes. Large amounts of fluorine-18, carbon-11, nitrogen-13, and oxygen-15 can be produced for synthesis into compounds used in oncology, cardiology, neurology, and molecular imaging. New Products in Development Brachytherapy Products The company has exclusively licensed Yttrium-90 (Y-90) polymer composite technology from Battelle Memorial Institute, developed at Pacific Northwest National Laboratory, a research institute for government and commercial customers. The license agreement grants the company the exclusive right to manufacture and market products using the Yttrium-90 isotope carried by an injectable water-based biodegradable polymer. Subject to receipt of all required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, the company plans to introduce a new Y-90-based brachytherapy product line for a range of applications for the delivery of a prescribed dose of radiation to a target site. After receipt of the requisite regulatory clearances, the company plans initially to introduce three products based on the patented technologies licensed from Battelle: Y-90 RadioGel device: It combines Y-90 particles with a polymer carrier that may be injected directly into the tumor. The Y-90 RadioGel device enables delivery of higher radiation doses to tumors than can be achieved with traditional seeds and with greater sparing of nearby normal tissues. Y-90 Fast-Resorbable Polymer Seeds: Y-90 contained within a polymer seed, as opposed to metal or glass. This product would be used in place of treating cancers with marketed titanium or glass seeds. Y-90 Polymer Topical Paste: This product may be applied directly to tissue surfaces after surgical tumor removals (also referred to as resections) to treat residual tumor cells. Sales Agency Activities The company engages in sales agency activities for worldwide distribution of O-18 enriched water. In addition, the company has the ability to act as a sales agency for other stable isotopes, as well as radioactive isotopes. Strategy The business strategy results from the company’s development of a family of three brachytherapy devices. The company’s business strategy also contemplates that it would resume operation of its linear accelerator located in Kennewick, consider building a larger cyclotron production facility in Southern California in partnership with a major medical facility and continue its research and development activities for other isotopes and technologies, though the pace of all activities would be subject to its financial capabilities and the needs and performance of the company’s strategic priorities, particularly the successful launch and growth of the brachytherapy products. Customers The company’s customers for sales of stable isotopes have included a range of hospitals, universities, research centers and national laboratories, in addition to academic and government institutions. These customers are located in major U.S. and international markets. Sales of F-18 for 2013, were to two regional hospitals, Kadlec Hospital in Richland, Washington and Kennewick General Hospital in Kennewick, WA. The company anticipates that customers for its brachytherapy products would include those institutions and individuals that purchase brachytherapy products or other oncology treatment products. Government Regulation The company’s operations are subject to rules and regulations administered by the U.S. Nuclear Regulatory Commission, Department of Energy, Food and Drug Administration, Department of Transportation, Department of Homeland Security, the Washington State Department of Health and other regulatory bodies.
