COMPANY CONFIDENTIAL Jason Koshnitsky Alan Sliski (508) 202-7224

COMPANY CONFIDENTIALCOMPANY CONFIDENTIAL

Jason KoshnitskyAlan Sliski

(508) 202-7224www.orbitaltherapy.com


AGENDAAGENDA

CompanyCompany

ProjectsProjects

CollaborationCollaboration


COMPANY OVERVIEWCOMPANY OVERVIEW

Dedicated Radiotherapy Device for the Treatment of Breast CancerDedicated Radiotherapy Device for the Treatment of Breast Cancer

MammoKnifeTM


LOCATION LOCATION

8 Alfred CircleBedford, MA 01730


CORE TEAMCORE TEAM

Jason Koshnitsky - CEO 18 years of experience in the area of radiation oncology radiology Held Sr. Mgmt roles in various 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 20 years of relevant physics experience B.S. Physics from the Lowell University M.S. in Physics & Astronomy from Boston University


ConsultantsConsultants

Ken Harte, Radiation Physicist38 years experience in electron and photon beam technologyWorked and/or consulted for companies including Varian, Perkin-Elmer, Micronic Laser, and Carl ZeissExperience with electron-optical design for semiconductor lithography and radiation therapy devicesMore than 15 years experience with Monte Carlo methods for simulating radiation therapy sourcesB.S. in physics from Rensselaer Polytechnic Institute and a Ph.D. in physics from Harvard

Paul Sebring, Mechanical EngineerMore than 25 years of mechanical design experience to the medical imaging industryConsulting for clients like XRE Corporation, GE Lunar, Stereotaxis Inc, and the University of TexasExpertise in CAD-based mechanical design and manufacture of mechanical assemblies

Michael Barenboym, Industrial Design & Mechanical EngineeringPresident and founder of Baren-Boym CompanyBS & MS in Mechanical Engineering from Moscow Institute of TechnologyWorked in the medical device industry in senior engineering and managerial positions


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

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

Jacquelyn Yanch, Ph.D. Professor of Nuclear Engineering at MIT, Cambridge, MA Expert in Monte Carlo, radiation measurements and nuclear physics


AGENDAAGENDA

CompanyCompany

ProjectsProjects



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 (?)

MammoKnifeMammoKnife

Source: NYU

* Confirmed by an FDA expert


PRODUCTPRODUCTUpdated DesignUpdated Design

MammoKnifeTM

SAD approx. 2.3MNo flattening filterFixed horizontal beam


PRODUCTPRODUCTFull Scale ModelFull Scale Model


PRODUCTPRODUCTFull Scale ModelFull Scale Model


Validation of Analytical ToolsValidation of Analytical Tools


Validation of Analytical ToolsValidation of Analytical Tools


Shielding Model Shielding Model


CLEAR-VUECLEAR-VUEProne Table-Top Attachment with Multi-Angle AccessProne Table-Top Attachment with Multi-Angle Access


MARKETMARKETEmergence of Prone-Based RT Table TopsEmergence of Prone-Based RT Table Tops


CLEAR-VUECLEAR-VUEErgonomic Design Table


AGENDAAGENDA

CompanyCompany

ProjectsProjects



Potential Collaboration w/MGHPotential Collaboration w/MGH

1) Basic physics

2) Definition of treatment protocols/techniques with 360 degree access (whole breast, partial breast, accelerated, SRS, etc…)

3) Potential benefits from lower whole body dose

4) Grants

5) Help define machine parameters

6) ????


DISCUSSIONDISCUSSION

MLC Questions:

• Leaf resolution at isocenter?

• Overtravel – how much?

• Maximum allowable penumbra?


DISCUSSIONDISCUSSION

• Dose Rate• Step & Shoot vs. Dynamic TX• Image Guidance/ Imaging Modalities• Adaptive RT (move beam to patient)

• Field Size

Y = ?

X = ?


BACKUPBACKUP


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


2006 ACS Estimates

213K New Cases40K Deaths

31% of Women’s Cancer22% of ALL Cancer

Male Total720K

Female Non-Breast467K

FemaleBreast

MARKETMARKET

Patient PopulationPatient Population Leading cancer in women --- 31% of women’s cancers Leading cancer overall --- 22% of all cases Accounts for nearly one quarter of all patients in radiotherapy 213,000 new breast cancer cases in 2006 --- 40,000 deaths (US) Increasing with aging population and earlier detection Longer survival with increased concern about secondary effects of RT

Source: IMV Report 2004


MARKETMARKETRadiotherapy Device MarketRadiotherapy Device Market

Worldwide multi-billion dollar market US and Europe account for over $1 billion and 500 units per year Close to 2000 RT facilities in US and 1000 in Europe Major equipment shortage in developing countries Most facilities in the US still have 1 treatment unit PROTON therapy around the CORNER – not for breast

Source: IMV Report 2004


Compare breathing motion, target separation from normal tissue and the resulting dose difference between prone and supine positioning in APBI in helical tomotherapy.

BENEFITS of PRONEBENEFITS of PRONE


MARKETMARKETEmergence of Special Purpose Radiotherapy DevicesEmergence of Special Purpose Radiotherapy Devices

Tomotherapy (IMRT) Accuray (SRS) Gammaknife (brain) Mammosite (breast balloon) Xoft (breast balloon) Zeiss (breast intra-op)

Xoft

Tomotherapy

Accuray - CyberKnife


Dynamics & TrendsDynamics & TrendsClinical Increase in early stage detection as a result of more/better

screening Shift from mastectomy to lumpectomy (more invasive to less invasive) Increased use of anatomy-specific therapy equipment Longer survival rates driving more emphasis on long-term

outcomes Proton therapy around the corner – not well suited for breast

Economic Reimbursement driving technological change IMRT & IGRT increasing per patient treatment time Throughput per accelerator is decreasing, population increasing Price of accelerators is increasing, demand is growing

MARKETMARKET


AGENDAAGENDA

Company & ProductCompany & Product

TeamTeam

MarketMarket

Financial ModelsFinancial Models


OVERVIEWOVERVIEW

($10,000,000)

($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

$40,000,000

Year 1 Year 2 Year 3 Year 4 Year 5

Sales

Gross Margin

Net Profit

Break-even in YR 4, with significant profit in YR 5


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 data – initial results poorNo long-term data – initial results poor 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


MammoSite DataMammoSite Data

Red Journal (Aug, 2007)

Dr. Chen, Rush University, Chicago

• 26 month follow-up of MammoSite balloon for 78 patients

• Out of 78 patients 4 patients had reccurence in the same breast - 5.7% failure rate


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


MARKETMARKETProcess is changing

Yesterday Today/Tomorrow

Patient setup using lasers

Delivery of static fields (2-4)

Approximate 15 min/ patient

Average 30-40 pts/ day

Patient setup using lasers or cameras

Stereoscopic or cone-beam CT images acquired

Digital reconstruction of images

Comparison of planned vs actual images

Patient repositioning

Delivery of IMRT segments (2-8 flds)

Approximate 20 min/ patient

Time loss of 150-200 min per machine/ day

IGRT reimbursement

IMRT reimbursement


MARKETMARKETEmergence of Prone-Based Imaging DevicesEmergence of Prone-Based Imaging Devices

New prone imaging devices Add-on table accessories for imaging Biopsy tables

Koning cone-beam CT mammography

Advance Technology Research – Optical Imaging

Hologic – Biopsy Table


Dr. Silvia Formenti – ASTRO 2007 presentationDepartment of Radiation Oncology, NYU School of Medicine, New York,

Compared dose to heart, lung etc of supine vs. prone205/225 patients treated in prone position

Supine or Prone

BENEFITS of PRONEBENEFITS of PRONE

Documents

COMPANY CONFIDENTIAL Jason Koshnitsky Alan Sliski (508) 202-7224