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COMPANY CONFIDENTIAL Welcome NIST Orbital Therapy, LLC
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COMPANY CONFIDENTIAL AGENDA Company & Product Team First Year Plans Project Milestones
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COMPANY CONFIDENTIAL COMPANY OVERVIEW Massachusetts LLC entity established in 2007 Holding company DE S-corporation established in 2006 Registered in the State of MA in 2006 Supported by a $2M ATP/NIST grant & private funds Equal equity split between 2 founders (Koshnitsky/Sliski) Provisional patent filed in Q1, 2006 Utility patent application filed in Q3, 2006 2 additional provisional patents filed in Q3, 2007 3 man-years plus $30K invested to-date between partners Dedicated Radiotherapy Device for the Treatment of Breast Cancer
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COMPANY CONFIDENTIAL External Radiation CLASSIC TX Current/Classic Treatment Technique Patient in supine position (back) Whole breast is treated Lung and heart are effected Multi-purpose linear accelerator used
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COMPANY CONFIDENTIAL CURRENT TX OPTIONS Pros: 5 day treatment Minimal dose to lung Cons: Very select patient group(<1cm, deep seated) Limited volumetric coverage – poor initial clinical results starting to surface clinical results starting to surface No long-term data Limited to one technique Invasive Infections due to invasive technique Pros: Proven gold standard treatment Complete volume treated Non-invasive Cons: 6 week regiment Dose to lung and heart Hard to perform partial breast RT Limited to technique used 2 extremes Very Little or All Balloon RTExternal RT
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COMPANY CONFIDENTIAL Dedicated Radiotherapy Device for the Treatment of Breast Cancer 510K FDA clearance – predicate device is a linear accelerator* Will NOT require clinical trials* Patient in prone position (face down) to isolate the treatment site Commercial accelerator sub-system (Siemens, Varian, other) Maintain and improve on current standard of care (skin sparing, homogeneous dose, whole or partial breast RT) Capable of delivering new emerging techniques (partial breast, accelerated, stereotactic radiosurgery, intensity modulated, etc) Machine is self-shielding not requiring primary beam shielding Compatible with existing, approved Treatment Planning SW from multiple vendors PRODUCT Source: NYU * Confirmed by an FDA expert
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COMPANY CONFIDENTIAL PROCESS Set-Up
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COMPANY CONFIDENTIAL PROCESS Beam-On
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COMPANY CONFIDENTIAL PROCESS Treatment Delivery
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COMPANY CONFIDENTIAL PROCESS Treatment Delivery
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COMPANY CONFIDENTIAL PROCESS Treatment Delivery
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COMPANY CONFIDENTIAL PROCESS Treatment Delivery
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COMPANY CONFIDENTIAL PRODUCT Updated Design Table rotates 360 degrees Fixed gantry linear accelerator Self-shielding design
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COMPANY CONFIDENTIAL PRODUCT Updated Design
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COMPANY CONFIDENTIAL KEY BENEFITS Patient Reduced dose to lung and heart – reduced long term complications Better separation of target volume from critical structures – less adverse effects Receive whole or partial breast irradiation – pathology specific treatment Much less (or none) dose caused by scatter to eyes, skin and other organsClinic Savings compared to purchase of a new linac > $1M No bunker needed - savings >$1M Free up space on already busy linac Reduced planning & treatment time due to elimination of target motionPhysician Ability to use advanced treatment techniques (IMRT, SRS, PBI) Chose better treatment strategy depending on patient Limit exposure to healthy organs
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COMPANY CONFIDENTIAL REIMBURSEMENT BE at 125 pts (~15/d for 1YR)
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COMPANY CONFIDENTIAL REIMBURSEMENT 10 pts/day for 1 YR BE ~ 1.7 yrs 20 pts/day for 1 YR BE < 1 yr
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COMPANY CONFIDENTIAL SYSTEM BLOCK DIAGRAM
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COMPANY CONFIDENTIAL DIGITAL CONTROL PANEL
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COMPANY CONFIDENTIAL MammoKnife core patent filed and additional 2 patents submitted Awarded a $2M ATP/NIST Grant Applied for $300K SBIR Grant in collaboration with CTRC San Antonio (U of Texas) Legal entity and structure established Concept validated with leading scientists and physicians Management team with relevant experience and track record in place Core European team recruited and headquarters with service center established Medical Advisory Board headed by Dr. Formenti of NYU (pioneer of prone breast RT) Letters of Intent received from clinical collaborators European and US distribution and service organizations identified Component suppliers and production facilities identified and contacted KEY ACHIEVEMENTS
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COMPANY CONFIDENTIAL IP Review 1 utility, 2 provisional filings 1 utility, 2 provisional filings 1 st covers prone, shielded, table or source rotating 1 st covers prone, shielded, table or source rotating 2 nd covers a prone table top for standard linacs for improved coverage 2 nd covers a prone table top for standard linacs for improved coverage 3 rd covers a shielded therapy machine generally 3 rd covers a shielded therapy machine generally
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COMPANY CONFIDENTIAL Prone machine patent
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COMPANY CONFIDENTIAL Shielded machine patent
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COMPANY CONFIDENTIAL AGENDA Company & Product Team First Year Plans Project Milestones
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COMPANY CONFIDENTIAL EMPLOYEES Jason Koshnitsky - CEO 16 years of experience in the area of radiation oncology radiology Held Sr. Mgmt roles in American, European and Israeli companies including Guidant, Philips and Orex/Kodak Co-founder of Bioropa, an internet portal for life science products Lived in Italy, Belgium, Ukraine, Germany and Netherlands B.S. in Medical Physics from State University of New York ESC M.B.A. from SDA Bocconi (Milan, Italy). Alan Sliski - CTO 17 years of experience in radiotherapy device business Co-founder of Photoelectron Corp, a Thermo Electron spin-off Co-founder of Still River Systems, a start-up building proton therapy systems Start-up experience in the Boston area doing electron beam lithography and magnetic measuring instruments B.S. in physics from the University of Massachusetts in Amherst 24 patents issued, several pending and many publications in various fields Michael Dalterio – Experimental Physicist xxxxxxx xxxxxxxx
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COMPANY CONFIDENTIAL ADVISORS Clinical/Scientific Participants & Advisors Silvia Formenti, M.D. Professor and Chief Radiation Oncologist – New York University, NY, NY Pioneer and key opinion leader in the area of prone breast radiotherapy Chandan Guha, Ph.D., M.D. Associate Professor and Chief Radiation Oncologist – Montefiore Medical Center, Bronx, NY Using prone treatments in his department Alan Alfieri, M.S. Chief Radiobiologist and Associate Professor – Montefiore/Albert Einstein College of Medicine, Bronx, NY 30 years of research and business consulting experience in the area of radiation therapy Peter Biggs, Ph.D. Chief Physicist of Photon Radiotherapy and Shielding – Mass General Hospital, Boston, MA AAPM instructor on radiation shielding and protection IEC committee member Niko Papanikolaou, Ph.D. Professor and Director of Cancer Therapy Research Center at San Antonio, University of Texas Expert in Monte Carlo simulations, oncology imaging and treatment planning software
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COMPANY CONFIDENTIAL CONSULTANTS Clinical/Scientific Participants & Advisors Ken Hart, Ph.D. >>>>>>>>>>>>>>> >>>>>>>>>>>>>> Paul Sebring, M.E. >>>>>>>>>>>>>> Paul Boisseau, Ph.D. >>>>>>>>>>>>>> >>>>>>>>>>>>>>>>> Peter Biggs, Ph.D. Chief Physicist of Photon Radiotherapy and Shielding – Mass General Hospital, Boston, MA AAPM instructor on radiation shielding and protection IEC committee member Jacquelyn Yanch, Ph.D. Professor of Nuclear Engineering, MIT Monte Carlo simulation and analysis
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COMPANY CONFIDENTIAL AGENDA Company & Product Team First Year Plans Project Milestones
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COMPANY CONFIDENTIAL QUESTIONS from NIST Status of the project as it starts First year plans for the project Project milestones go/no-go points Updates or changes to the technical work plans – none to date Company’s business status and update – LLC formation
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COMPANY CONFIDENTIAL Q4/Q1 (07/08) Key Goals Generate first system specifications Overall configuration Functional specification Identify all applicable standards and regulations Set-up Monte Carlo model – first results Obtain linac monte carlo model Model basic shielding properties Generate first pass mechanical design Design for first full-scale model Design first shielding experiment Mechanical design and materials identified Equipment specified and test plan written
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COMPANY CONFIDENTIAL System Features 4-6MV LINAC source from Siemens or Varian 4-6MV LINAC source from Siemens or Varian 20x20cm field size at isocenter 20x20cm field size at isocenter Multileaf collimator customized to this application, 40+40 leaves Multileaf collimator customized to this application, 40+40 leaves Rotating patient table Rotating patient table Optical patient alignment Optical patient alignment Granular shielding material for ease of transport, installation, decommissioning Granular shielding material for ease of transport, installation, decommissioning Integrated shielding Integrated shielding
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COMPANY CONFIDENTIAL Monte Carlo system model Model 6MV accelerator Model 6MV accelerator Generate rough estimate of how much shielding is required around LINAC, collimator, beam dump Generate rough estimate of how much shielding is required around LINAC, collimator, beam dump Explore beam dump concepts: geometry, materials Explore beam dump concepts: geometry, materials
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COMPANY CONFIDENTIAL Experimental shielding validation Design test configuration for different materials Design test configuration for different materials Choose detector for good sensitivity, some spectral information Choose detector for good sensitivity, some spectral information Order heavy stuff, build test fixture Order heavy stuff, build test fixture Measure results with local LINAC Measure results with local LINAC
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COMPANY CONFIDENTIAL Near term technical focus Monte Carlo modeling of system elements Monte Carlo modeling of system elements Experimental validation of shielding Experimental validation of shielding Samples: solid lead, lead shot, tungsten powder Samples: solid lead, lead shot, tungsten powder Generate first-pass mechanical design Generate first-pass mechanical design Build a full scale model to visualize concepts Build a full scale model to visualize concepts
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COMPANY CONFIDENTIAL Full scale model Build first pass mechanical design for visual concept introduction to customers, collaborators Build first pass mechanical design for visual concept introduction to customers, collaborators Include linac, collimator model, rotating table top Include linac, collimator model, rotating table top Aluminum framing, acrylic and plywood Aluminum framing, acrylic and plywood
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COMPANY CONFIDENTIAL First pass mechanical design Incorporate linac, collimator, table top with rotation, cameras, beam dump Incorporate linac, collimator, table top with rotation, cameras, beam dump Present design concept to MDs Present design concept to MDs Generate 3D videos/images for presentations Generate 3D videos/images for presentations
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COMPANY CONFIDENTIAL AGENDA Company & Product Team First Year Plans Project Milestones
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COMPANY CONFIDENTIAL MAJOR TASKS YRS 1 & 2
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COMPANY CONFIDENTIAL PROJECT TIMELINE
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COMPANY CONFIDENTIAL PROJECT TIMELINE
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COMPANY CONFIDENTIAL PROJECT TIMELINE
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