COMPANY CONFIDENTIAL Welcome NIST Orbital Therapy, LLC

COMPANY CONFIDENTIALCOMPANY CONFIDENTIAL

Welcome NIST

Orbital Therapy, LLC


AGENDAAGENDA

Company & ProductCompany & Product

TeamTeam

First Year PlansFirst Year Plans

Project MilestonesProject Milestones


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


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


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


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


PROCESSPROCESSSet-UpSet-Up


PROCESSPROCESSBeam-OnBeam-On


PROCESSPROCESSTreatment DeliveryTreatment Delivery








PRODUCTPRODUCTUpdated DesignUpdated Design

Table rotates 360 degrees

Fixed gantry linear accelerator

Self-shielding design


PRODUCTPRODUCTUpdated DesignUpdated Design


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


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


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


SYSTEM BLOCK DIAGRAMSYSTEM BLOCK DIAGRAM


DIGITAL CONTROL PANELDIGITAL CONTROL PANEL


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


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


Prone machine patentProne machine patent


Shielded machine patentShielded machine patent


AGENDAAGENDA


TeamTeam




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


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


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


AGENDAAGENDA


TeamTeam




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


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


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


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


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


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


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


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


AGENDAAGENDA


TeamTeam




MAJOR TASKS YRS 1 & 2MAJOR TASKS YRS 1 & 2


PROJECT TIMELINEPROJECT TIMELINE





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COMPANY CONFIDENTIAL Welcome NIST Orbital Therapy, LLC