Post on 12-Jan-2016
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Welcome NIST
Orbital Therapy, LLC
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COMPANY OVERVIEWCOMPANY 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 CancerDedicated Radiotherapy Device for the Treatment of Breast Cancer
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External Radiation
CLASSIC TXCLASSIC TX
Current/Classic Treatment TechniqueCurrent/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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CURRENT TX OPTIONSCURRENT TX OPTIONS
Pros:Pros: 5 day treatment5 day treatment Minimal dose to lungMinimal dose to lung
Cons:Cons: Very select patient group(<1cm, deep seated)Very select patient group(<1cm, deep seated) Limited volumetric coverage – poor initial Limited volumetric coverage – poor initial clinical results starting to surface clinical results starting to surface No long-term dataNo long-term data Limited to one techniqueLimited to one technique InvasiveInvasive Infections due to invasive techniqueInfections due to invasive technique
Pros:Pros: Proven gold standard treatment Proven gold standard treatment Complete volume treated Complete volume treated Non-invasiveNon-invasive
Cons:Cons: 6 week regiment6 week regiment Dose to lung and heartDose to lung and heart Hard to perform partial breast RTHard to perform partial breast RT Limited to technique usedLimited to technique used
2 extremes
Very Little or All
Balloon RT External RT
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Dedicated Radiotherapy Device for the Treatment of Breast Dedicated Radiotherapy Device for the Treatment of Breast CancerCancer 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
PRODUCTPRODUCT
Source: NYU
* Confirmed by an FDA expert
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PROCESSPROCESSSet-UpSet-Up
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PROCESSPROCESSBeam-OnBeam-On
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PROCESSPROCESSTreatment DeliveryTreatment Delivery
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PROCESSPROCESSTreatment DeliveryTreatment Delivery
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PROCESSPROCESSTreatment DeliveryTreatment Delivery
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PROCESSPROCESSTreatment DeliveryTreatment Delivery
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PRODUCTPRODUCTUpdated DesignUpdated Design
Table rotates 360 degrees
Fixed gantry linear accelerator
Self-shielding design
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PRODUCTPRODUCTUpdated DesignUpdated Design
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KEY BENEFITSKEY BENEFITS
PatientPatient 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 organs
ClinicClinic 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 motion
PhysicianPhysician 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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REIMBURSEMENTREIMBURSEMENTBE at 125 pts (~15/d for 1YR)BE at 125 pts (~15/d for 1YR)
Cost AssumptionsProperty 200000Equipment (MammoKnife) 2000000Extended Warranty (after yr 1) 150000Staff 200000
Amt PCH codePort film (weekly) 24 77417IMRT per fraction 688 77418IMRT planning 1114 77301
IMRT Whole BreastFractions (average) 30Port films 5
Total per patient 21874
Patient Based Break Even
-$3,000,000
-$2,000,000
-$1,000,000
$0
$1,000,000
$2,000,000
$3,000,000
0 10 25 50 75 100 150 200 250
Patients
Pro
fit
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REIMBURSEMENTREIMBURSEMENT
10 pts/day for 1 YRBE ~ 1.7 yrs
20 pts/day for 1 YRBE < 1 yr
Lifecycle Pro forma
-$4,000,000
-$2,000,000
$0
$2,000,000
$4,000,000
$6,000,000
$8,000,000
$10,000,000
$12,000,000
$14,000,000
0 1 2 3 4 5 6 7 8 9 10
Year
Pro
fit
Lifecycle Pro forma
-$5,000,000
$0
$5,000,000
$10,000,000
$15,000,000
$20,000,000
$25,000,000
$30,000,000
$35,000,000
0 1 2 3 4 5 6 7 8 9 10
Year
Pro
fit
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SYSTEM BLOCK DIAGRAMSYSTEM BLOCK DIAGRAM
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DIGITAL CONTROL PANELDIGITAL CONTROL PANEL
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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 ACHIEVEMENTSKEY ACHIEVEMENTS
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IP ReviewIP Review
1 utility, 2 provisional filings1 utility, 2 provisional filings
11stst covers prone, shielded, table or source covers prone, shielded, table or source rotatingrotating
22ndnd covers a prone table top for standard covers a prone table top for standard linacs for improved coveragelinacs for improved coverage
33rdrd covers a shielded therapy machine covers a shielded therapy machine generallygenerally
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Prone machine patentProne machine patent
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Shielded machine patentShielded machine patent
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AGENDAAGENDA
Company & ProductCompany & Product
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First Year PlansFirst Year Plans
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EMPLOYEESEMPLOYEES
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 xxxxxxx xxxxxxxx
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ADVISORSADVISORS
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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CONSULTANTSCONSULTANTS
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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AGENDAAGENDA
Company & ProductCompany & Product
TeamTeam
First Year PlansFirst Year Plans
Project MilestonesProject Milestones
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QUESTIONS from NISTQUESTIONS 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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Q4/Q1 (07/08) Key GoalsQ4/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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System FeaturesSystem Features
4-6MV LINAC source from Siemens or Varian4-6MV LINAC source from Siemens or Varian
20x20cm field size at isocenter20x20cm field size at isocenter
Multileaf collimator customized to this application, Multileaf collimator customized to this application, 40+40 leaves40+40 leaves
Rotating patient tableRotating patient table
Optical patient alignmentOptical patient alignment
Granular shielding material for ease of transport, Granular shielding material for ease of transport, installation, decommissioning installation, decommissioning
Integrated shieldingIntegrated shielding
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Monte Carlo system modelMonte Carlo system model
Model 6MV acceleratorModel 6MV accelerator
Generate rough estimate of how much shielding is Generate rough estimate of how much shielding is required around LINAC, collimator, beam dumprequired around LINAC, collimator, beam dump
Explore beam dump concepts: geometry, materialsExplore beam dump concepts: geometry, materials
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Experimental shielding validationExperimental shielding validation
Design test configuration for different materialsDesign test configuration for different materials
Choose detector for good sensitivity, some Choose detector for good sensitivity, some spectral informationspectral information
Order heavy stuff, build test fixtureOrder heavy stuff, build test fixture
Measure results with local LINACMeasure results with local LINAC
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Near term technical focusNear term technical focus
Monte Carlo modeling of system elementsMonte Carlo modeling of system elements
Experimental validation of shieldingExperimental validation of shielding
Samples: solid lead, lead shot, tungsten powderSamples: solid lead, lead shot, tungsten powder
Generate first-pass mechanical designGenerate first-pass mechanical design
Build a full scale model to visualize conceptsBuild a full scale model to visualize concepts
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Full scale modelFull scale model
Build first pass mechanical design for visual Build first pass mechanical design for visual concept introduction to customers, collaboratorsconcept introduction to customers, collaborators
Include linac, collimator model, rotating table topInclude linac, collimator model, rotating table top
Aluminum framing, acrylic and plywoodAluminum framing, acrylic and plywood
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First pass mechanical designFirst pass mechanical design
Incorporate linac, collimator, table top with Incorporate linac, collimator, table top with rotation, cameras, beam dumprotation, cameras, beam dump
Present design concept to MDsPresent design concept to MDs
Generate 3D videos/images for presentationsGenerate 3D videos/images for presentations
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MAJOR TASKS YRS 1 & 2MAJOR TASKS YRS 1 & 2
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PROJECT TIMELINEPROJECT TIMELINE
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PROJECT TIMELINEPROJECT TIMELINE
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PROJECT TIMELINEPROJECT TIMELINE