DebrideX Surgical Strategy & Business Plan. Our Team Grygorii Yefremov - CEO Ranjan Upadhyay - CFO Prasant Varghese - CMO Krishn Khanna - CRO Srinivas.

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Presentation transcript:

debrideX Surgical Strategy & Business Plan

Our Team Grygorii Yefremov - CEO Ranjan Upadhyay - CFO Prasant Varghese - CMO Krishn Khanna - CRO Srinivas Chivukula - CTO

Executive Summary Head and neck surgeries currently employ microdebriders with tips of fixed angles debrideX Surgical presents this challenge with a novel and efficient solution: a variable- angle debriding tip Company is expected to become profitable during the 4 th year Exit strategy: acquisition by a major biomedical company after the 5 th year

Company Overview Overview of the Product Provides angular flexibility to the functional unit of a microdebrider Advantages of this Product over Existing Technologies ▫Flexible tip ▫Less trauma ▫Economically more efficient for the consumer ▫A simpler mechanism = lower costs and higher profits Development Duration R&D ▫6 months - development of the tip ▫6 months - development of the base unit FDA approval and Fundraising ▫1 year - designing, manufacturing and clinical trials ▫Concurrently aiming for venture capital Marketing and Manufacturing ▫1 year - aggressive marketing campaign ▫Development of manufacturing facility Sales begin in the fourth year ▫2 years of sales – become profitable Acquisition

The Market Market Overview ▫37 million Americans with sinusitis per year (32 million – chronic) ▫300 thousand FESS surgeries alone per year ▫Net market = $5.8 billion, ▫Nearly 20% or $1.1 billion lies in the sinus surgery regime Customer Base 12,000 Otolaryngologists / ENT surgeons in America Hospitals and private practice Marketing of the Product Marketing representatives Advertise to ENT databases and conferences Competitors ▫Medtronic Xomed  60% of the market ▫Stryker ▫Gyrus, (an Olympus company)

Business Model Funding ▫Academic grants and design competitions ▫SBIR ▫Venture Capital Spending ▫R&D ▫FDA/clinical trials ▫Marketing ▫Manufacturing ▫Business Expenses Income ▫Base unit - $10,000 each ▫Tip - $500 ▫Disposable blade - $100 ▫Biannual Maintenance - $750

Design & Development Design Selection ▫Selection criterion = effectively transferring blade motion through a flexible tip Prototyping ▫CAD software prototyping ▫Modeling of functionality ▫Final prototype Constant Evaluation and Reevaluation of Design Among the more important evaluation criteria will be: ▫Torque ▫RPM ▫RPM variability ▫Deflection angle and curvature ▫Temperature of the shaft ▫Suction power ▫Minimal achievable diameter ▫Sterilization techniques

DS5

DS5 Cont’d (1) Blade Diagram – Side ViewTurbine Chamber – X-Section

DS5 Cont’d (2) Bent Joint of the Tip

DS6 Prototype Ideas

DS6 (cont’d) Priorities ▫Well-controlled, bendable joint ▫Low friction blade rotation ▫Disposable parts

Financials & Timeline Research and Development Phase (Months 1-12) COSTREVENUE EXPENSETOTALINCOMETOTAL Flexible Tip Materials$500Columbia University Funding$500 Base Unit Materials$3,000BME Design Grants$1,000 Polishing and Finalizing Product$10,000SBIR Grants (Tentative)$20,000 Patent Applications$10,000 Employee Salaries$80,000 Office Upkeep$18,000 Total Expenses($121,500)Total Income$21,500 YEAR 1 EARNINGS($100,000) NET LOSS($100,000) FDA Approval and Fund Raising Phase (Months 12-24) COSTREVENUE EXPENSETOTALINCOMETOTAL Travel Expenses$10,000 Design Updates$5,000 Clinical Trials$100,000 Employee Salaries$160,000 Office Upkeep$18,000 Total Expenses($293,000)Total Income$0 YEAR 2 EARNINGS($293,000) NET LOSS($393,000)

Financials & Timeline Advertising and Manufacturing Phase (Months 24-36) COSTREVENUE EXPENSETOTALINCOMETOTAL Advertising Materials$4,500 Design Updates$5,000 Initial Stage Manufacturing Costs$147,500 Employee Salaries$510,000 Travel Expenses for Representatives$50,000 Factory Upkeep$46,000 Total Expenses($763,000)Total Income$0 YEAR 3 EARNINGS($763,000) NET LOSS($1,156,000) Early Sales Phase (Months 36-48) COSTREVENUE EXPENSETOTALINCOMETOTAL Advertising Materials$3,500Base Unit Sales$750,000 Research and Development$15,000Tip Sales$750,000 Manufacturing Costs$395,000Disposable Blade Sales$750,000 Employee Salaries$435,000Maintenance Costs$150,000 Travel Expenses for Reps and Techs$90,000 Factory Upkeep$46,000 Total Expenses($984,500)Total Income$2,400,000 YEAR 4 EARNINGS$1,415,500 NET PROFIT$259,500 Target Venture Capital Investment: $ 1.2 million

Financials & Timeline Late Sales Phase (Months 48-60) COSTREVENUE EXPENSETOTALINCOMETOTAL Advertising Materials$3,500Base Unit Sales$1,500,000 Research and Development$15,000Tip Sales$2,250,000 Manufacturing Costs$605,000Disposable Blade Sales$2,250,000 Employee Salaries$435,000Maintenance Costs$225,000 Travel Expenses for Reps and Techs$90,000 Factory Upkeep$46,000 Total Expenses($1,194,500)Total Income$6,225,000 YEAR 5 EARNINGS$5,030,500 NET PROFIT$5,290,000

Acknowledgements Henry Hess, Ph.D. Associate Professor of Biomedical Engineering Columbia University Elizabeth Hillman, Ph.D. Assistant Professor of Biomedical Engineering Columbia University Keith Yeager, M.Sc. Laboratory Machine Manager, Dept. of Biomedical Engineering Columbia University Lauren Grosberg Teaching Assistant, Dept. of Biomedical Engineering Columbia University