Breakthroughs in Medical Isotope Technology 2019 Mo-99 Topical Meeting Heather Murphy, Commercial Operations Manager BWXT ITG Canada, Inc. BWXT Company Overview 1) As of June 30, 2019 2 Nordion Medical Isotopes Business Acquisition . Reputation as a pioneer in reactor and cyclotron isotope and radiopharmaceutical production . Extensive infrastructure – cyclotrons, hotcells, manufacturing suites, labs . 40 year relationship with TRIUMF (Vancouver) . Highly trained, experienced, professional staff . CNSC-licensed facilities in Kanata, Ontario and Vancouver, BC . World class nuclear transport container fleet o Acquisition Closed: July 30, 2018 . Current Products Include: . Iodine-123/Oral Iodine-123 . Strontium-82 . Indium-111 . Palladium-103 . In-111 oxyquinoline (Q3, 2019) . Contract Manufacturing Tc-99m – A Powerful Diagnostic Tool Why Tc-99m is so critical? How is it made (historically)? . Physiological diagnostic technique . Supplied in a Tc-99m generator . Used in 80% of all nuclear medicine imaging . scans, 30-40M patients per year globally Decay product of Mo-99 . Applications in cardiology, GI, oncology, . Mo-99 produced from the fission of U- neurology, pulmonary 235 targets . Targets irradiated primarily in research and test reactors outside of North America Over 5,000 lives will be directly . Considered the gold standard diagnostic test impacted by Tc-99m in the next 90 min for many conditions Mo-99/Tc-99m Market Issues . Security of Supply o Desire for long term, reliable and locally manufactured supply . Reduction in use of uranium in targets o Proliferation risk, inefficient, highly active liquid waste . Sustainable economics along supply chain o Nuclear Energy Agency’s High-level Group on Security of Supply of Medical Radioisotopes (HLG-MR) full cost recovery principle . Healthcare System Cost Containment o Diagnostic reimbursement pressure Tc-99m Generator Development . Designed to be user friendly . Comparable to currently available generators • Sizes (Activity level) • Eluent volume and activity concentration • Elution time • Dimensions/weight Tc-99m Generator Prototype Darlington Nuclear Irradiation Site . A world leader in reliable operation of multiple CANDU reactors . Proven nuclear safety track record . Multiple reactors on one site . Longtime producer of radioisotopes – Co-60, Tritium Progress Update . Target Design and Manufacturing o Targets designed o Manufacturing facility constructed and initial targets manufactured for testing . Target Delivery System o Full scale mock-up facility constructed o Testing underway . Target Processing o Processing equipment designed and configured o Full scale pilot plant constructed o Test runs underway . Processing/Manufacturing Facility o Hot cell modifications underway o New hot cells designed and ordered . Tc-99m Generator o Finalizing design elements BWXT Isotope Technologies: Solving the Key Industry Issues Local irradiation, processing and manufacturing o Returning North America to a leadership role in nuclear medicine o Leveraging BWXT innovation and former Nordion assets to de-risk commercialization o Securing local supply for North American patients Uranium-free targets o Completely eliminate proliferation risk o No long-lived isotopic fission waste Reliable, redundant irradiation in multiple reactors o Utilize highly reliable reactors o Predictable, high operating schedule.
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