CONTENTS ARE CONFIDENTIAL +1 508 904 3819 ORBITAL THERAPY, LLC Dedicated, self-shielded device for breast.

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Presentation transcript:

CONTENTS ARE CONFIDENTIAL ORBITAL THERAPY, LLC Dedicated, self-shielded device for breast radiotherapy

Company Profile  Founded in 2006 by Jason Koshnitsky & Alan Sliski with 45 years of combined radiotherapy industry experience.  Supported by: $2M NIST grant $250K Strategic investor $245K HHS grant $700K in sales revenue from current products Start-up funds from founders  Office located at 8 Alfred Circle, Bedford, MA  From idea to working prototype with < $2M COMPANY CONFIDENTIAL

Founders Jason Koshnitsky - CEO  23 years of experience in the area of radiation oncology & radiology  Held Sr. Management roles in American and European companies; Guidant, Philips  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)  3 patents issued, several pending Alan Sliski - CTO  23 years of experience in radiotherapy device business  Co-founder of Photoelectron Corp – acquired by Zeiss  Co-founder of Still River Systems (Mevion), a proton radiation therapy start-up  B.S. in physics from the University of Massachusetts in Amherst  29 patents issued, several pending and many publications in various fields

COMPANY CONFIDENTIAL Overview Improves on the gold standard of breast cancer treatment  Experienced management team  Intellectual property – 3 patents issued, 3 pending  Working proof-of-concept prototype complete  Strategic investor ($250K, top distributor in Europe)  Non-dilutive funding ($2M NIST/ATP grant, 245K HHS grant)  Proven and audited quality & accounting systems  510K regulatory path  No clinical trials required for FDA clearance  Reimbursement codes in place  Letters of intent received from hospitals in US and Europe  Off-the-shelf components (waveguide, collimator, etc)  Agreement to be finalized with a leading industry player (to supply Orbital with the full line of components and software)  Products commercialized and revenue recognized  Design and build 2 clinical units and 1 in-house unit FDA 510K and CE mark approvals

COMPANY CONFIDENTIAL Prototype Ready – Beam ON! Industrial Design Operator in room with patient Only breast in the “bunker” CAD model Drum contains 6MV accelerator, MLC Anti-reflective beam-stop Proof-of-concept Prototype built Beam turned on – no additional shielding added, operator in the same room

Clinical Benefits through Technology Improves upon the current gold standard of care of lumpectomy + radiotherapy > 95% of breast cancer patients receive radiation with breast conserving therapy  Full 360 degree access to the breast allows for modern treatment techniques such as IMRT, IGRT, SRS, PBI – not possible with standard treatment devices  Capability to deliver any type of treatment from Radiosurgery to Whole Breast  Radiosurgery can potentially replace lumpectomy for early stage disease  Integrated imaging improves targeting and treatment delivery Breakthrough patented integrated shielding  Lower dose to organs and rest of patient – patient “outside of the bunker”  Operator can be in room with patient

Prone VS Supine Key Benefits of Prone: Increased separation of breast from other organs Reduced organ/patient motion due to breathing Reduced dose to lung & heart

Self Shielded - VS - Bunker Key Benefits of Self-Shielded: Lower patient body dose of unwanted radiation Reduced cost of install – bunker can range from $1-5M Reduced time of install Simplified relocation – no tear down $2.1M – $2.6M machine $0 – $100K room $1M – $5M room $1M – $5M room + $2.5M - $4M machine

Minimum Technical Risk Proof of concept prototype built and tested Analytical tools validated Off the shelf linear accelerator sub-system Compatible with existing treatment planning software Standard 6MV radiation beam with multi-leaf collimator Standard cone-beam CT imaging system Patents issued COMPANY CONFIDENTIAL

System Configuration MammoKnife TM 6MV accelerator Multileaf Collimator Rotating Couch Anti-Reflective Beam Stop Integrated Shielding Cone-beam CT Image of breast in prone position COMPANY CONFIDENTIAL

Linac Suppliers Multiple vendors: Siemens – confirmed interest Elekta – confirmed interest Mevex – confirmed interest Varian Tomotherapy (Twin Peaks) Others (Asia, etc.) COMPANY CONFIDENTIAL

Vendor Independence Waveguides are very similar - all based on the Los Alamos design. EXAMPLE: Tomotherapy used Siemens, Mevex, and Chengdu Twin Peak COMPANY CONFIDENTIAL Siemens (Germany) Varian (U.S.) Mevex (Canada)

IP Summary US Patent 7,526,066 issued April 28, This issued patent covers the MammoKnife self-shielded radiation therapy machine and carves out space for the self-shielded system in the particular configuration of the prone breast system we have developed into a working prototype. US patent 7,758,241 issued July 20, This is a platform technology patent covering any geometry and configuration of highly shielded radiation therapy system US patent 8,272,088 issued Sep, “PATIENT SUPPORT SYSTEM FOR FULL ACCESS PRONE POSITION BREAST RADIOTHERAPY” filed September 8, Status: We are responding to the first office action. This patent covers the ClearVue table and the design principles embodied in it. Utility Application number 12/815,812 filed June 15, 2010 “PATIENT ALIGNMENT SYSTEM FOR DIAGNOSTIC AND THERAPEUTIC PROCEDURES” This patent application covers the laser alignment system used with the ClearVue table for patient alignment. It also covers the use of imaging systems in place of laser projectors. Utility Application number 12/859,390 filed August 19, 2010 “PATIENT SUPPORT WITH INTERCHANGEABLE INSERTS FOR PRONE BREAST PROCEDURES” This application covers the ClearVue table using interchangeable inserts. Utility Application number 13/035,983 filed February 27, 2011 “REDUCING IMAGING ARTIFACTS” This application covers the anti-artifact insert for the ClearVue table and other patient support devices. COMPANY CONFIDENTIAL

Issued Patent 7,526,066 COMPANY CONFIDENTIAL Radiation therapy system Radiation source Beam modulator Programmable beam Rotatable patient positioning system Patient interface Aperture for treating the anatomy Shielding Beam stop Patient shielded except anatomy treated Imaging to visualize the anatomy Mobile capabilities Covers the Mammoknife self-shielded radiation therapy machine and carves out space for the self-shielded system in the particular configuration of the prone breast system we have developed into a working prototype.

Issued Patent 7,758,241 COMPANY CONFIDENTIAL Radiation therapy shielding system Shielded radiation source Scatter shield to absorb patient scatter Beam stop to absorb exiting scatter Source rotation Source rotates about the patient Patient rotates about the source Imaging Portal (high energy beam) Ionizing radiation Optical Method for treating cancer Delivering treatment while maintaining scatter & leakage to background radiation levels Platform technology patent covering any geometry and configuration of highly shielded radiation therapy system.

COMPANY CONFIDENTIAL Go-To-Market Plan Customers  Existing Radiotherapy Centers -Hospitals -Free-standing private centers  Breast Centers/Surgeons -Forward integration is a trend -RT is an excellent profit center  Entrepreneurial MDs -New centers -Mobile facilities Sales Focus on US and EU  United States – HQ in MA -Major RT Partner (or) -Direct (or) -Service companies/refurbished equipment sellers  Europe – Major RT Partner or Dealers Pricing  List Price: $2.5M-$3.0M (conventional linear accelerator $2-4M + bunker approx. $1-5M)  Average Selling Price: $2.1-$2.6M  Target Gross Margin: around 60%

RT procedure volume growing at 7% per year* Breast cancer RT increased from 20% to 24% from 2007 to 2009* External beam accounts for 94% of all treatments* $4B radiotherapy market size ($1B breast) centers in US & EU A 5% market share = 50 units = $120M in annual sales Large Market Opportunity *Source: IMV Reports 2008 & 2010

 ClearVueTM prone breast table (patent pending) - CE & FDA clearance received - 50 units sold (US, Italy, NL, Germany, Australia) - Revenue realized - $17.5K List Developing Customer Relationships Key customers: MGH, MA Newton Wellesley Hosp, MA NYU, NY Montefiore, NY Einstein College of Med, NY Greenwich, CT University of Rochester, NY Baptist Hospital, FL Karmanos Cancer Ctr, MI Eurpean Inst of Oncology, Italy

Profitable in Year 4 COMPANY CONFIDENTIAL

Financial Needs & Exit Strategy Our goal is to have a trade sale within 2 years of Series A round ($15M). This round will fund the production of 2 clinical units, 1 in-house unit and FDA approval. A major industry player has expressed interest. We are looking to raise $15M, with a $5M minimum first tranche. Venture debt may be used. COMPANY CONFIDENTIAL