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Bio-Patch: Team M
                          Microneedle/Microchip Enabled Biosensor



Daily Contact Count: 23
Total Contact Count: 49




         Joan Affleck      Mike Dimitri    Kirim Kim     John Marshall   Matt Nudell
Insulin Injection!
 Wireless Data
 Transmission!
Business Model Canvas Day 1
HP                 Production      Smart drug       Inventory            Medical
                                   delivery         Control              supply
                   Platform /      system –                              companies
                   networking      chip and
                                                    Co-creation
                                   needle
                                                                         Insurance
                                                                         companies


                   HP patent                       Direct sales

                   CMOs



     CMOs,            Data                                  Data
     sales team,      collection           Direct DDS       collection
     general          tools                sales            fees
     admin
Discovery &
 Research
Business Model Canvas Day 2
                                           -- Smart drug            -- Inventory
                                           delivery system          Control
HP                         Production                                                  Med supply
                                           (chip and needle)        -- Co-creation     companies`
                                           -- Personalized
Hospitals / doctor         Platform /      medicine entry           -- Branding
offices                    networking                                                  Pharma
                                                                    -- Various uses
                                           -- Smart delivery                           companies
Insurance                  Licensing       system may                -- Personalized
companies                                  extend patent life        data monitoring   Patients
                                           -- Ease of use,
FDA
                                           time mgmt                                   Doctors
                                           -- Controlled
CMOs
                                           pain-free delivery                          Insurance
                           HP patent                                Direct sales       companies
                                           -- Lower patient
                           Cloud service   care costs
                                                                                       HP
                                           -- Purchasing
                           CMOs                                                        FDA
                                           -- Regulatory


         CMOs, sales                                            Direct DDS
         team, general                                          sales
         admin
                                                                Data collection
         Data collection
                                                                fees
         tools
FDA and PATENT
 Time and $$???
Business Model Canvas Day 3
                                            -- Smart drug            -- Inventory
                           Production       delivery system
Hospitals / doctor                                                   Control            Med supply
                                            (chip and needle)        -- Co-creation
offices                    Platform /                                                   companies`
                                            -- Personalized
                           networking       medicine entry           -- Branding
Pharma                                                                                  Pharma
companies                                                            -- Various uses
                           Licensing        -- Smart delivery                           companies
                                            system may                -- Personalized
Insurance                  Procure HP       extend patent life        data monitoring   Patients
companies                  patent
                                            -- Ease of use,
HP                                          time mgmt                                   Doctors
                                            -- Controlled
FDA                                         pain-free delivery                          Insurance
                           HP patent                                 Direct sales       companies
                                            -- Lower patient
CMOs                       Cloud service    care costs
                           BI Application                                               HP
                                            -- Purchasing
                           CMOs                                                         FDA
                                            -- Regulatory


         CMOs, sales                                             Direct DDS
         team, general                                           sales
         admin
                                                                 Data collection
         Data collection
                                                                 fees
         tools
Drug Delivery/
Insulin Injection
BioSensor Only
Business Model Canvas Day 4
Med Device                  Platform / networking      -- Smart drug delivery            -- Inventory
Companies                   Software development       system Biosensor (chip            Control                   Med Supply
                            / integration              and needle)                       -- Co-creation            Device
                                                       -- Personalized                                             Companies
Pharma companies
                            Patent development         biomarkers                        -- Branding
                                                                                         -- Clinical Studies       Pharma
Hospitals / Doctor                                                                                                 Companies
                            Procure HP patent          -- Smart delivery system
offices                                                                                  -- Personalized
                            Production                 -- Preventative                   data monitoring           Patients
Insurance companies
                                                       healthcare
                                                       -- Controlled pain-free                                     Hospitals /
HP Needle & chip mfg                                                                                               Doctors
                                                       delivery
Software Developer          HP patent                                                                              Insurance
                                                       -- Lower patient care             Direct sales
                                                       costs                                                       Companies
                            Cloud service
FDA
                            Patented software                                            Web-based                 HP
                                                       -- Purchasing
CMOs                                                                                     software
                            Manufacturing                                                download
                                                       -- Regulatory                                               FDA


           Hardware costs, CMOs, sales team, general                              Direct DDS Biosensor sales
           admin
                                                                                  Data collection fees
           Data collection tools                                                                               Biosensor customization
                                                                                  Application development
           Software development, patents, legal                                   fees
MVP – DVT
Patients Only
Business Model Canvas Day 5
Med Device                Software development
Companies                                           Biosensor                                                 Med Device
                          / integration                                               Co-creation
                                                                                                              Companies
                                                    Personalized biomarkers
Pharma companies          Patent Filing                                               Clinical Studies        Pharma
                                                    Preventative healthcare                                   Companies
Hospitals / Doctor        Production                                                  Personalized data
offices                                                                               monitoring              Patients
                                                    Lower patient care costs
Insurance companies
                                                                                                              Hospitals /
                                                    Regulatory                                                Doctors
Needle & chip mfg

                                                                                                              Insurance
Software Developer                                                                    Direct sales            Companies
                          Patented software
FDA
                                                                                      Web-based               FDA
CMOs                      Manufacturing                                               software
                                                                                      download




  Hardware costs, CMOs, sales team, general admin                              Direct Biosensor sales
                                                                                                          Biosensor customization
  Software development, patents, legal                                         Application development
                                                                               fees
Getting out of the building
• Total number of contacts: 49
  – Pharma industry subject matter experts in IT, business
    development, pharmacokinetics, clinical research
    directors
  – Medical device experts
  – Physicians specializing in diabetes, immunology,
    geriatrics
  – Life Science consultants
  – Private equity expert
  – Venture capital experts
  – Patients
Hypothesis Testing
         Hypothesis                        Test                         Result

Micro-needle self-             Interviewed Doctors, Board   TRUE-Patients dread self
application patches are        member of Medical Device     pricking & inaccurate testing
preferred over at-home and     Company, Pharmaceutical
hospital blood tests           Reps and Patients            MIXED-Would require proof
                                                            of concept, safety studies
                                                            and cost effectiveness
FDA regulation period will     Interviewed Consultant and   TRUE- 510(K), Class II
be less rigorous for           online research              device will take 3 to 5 years,
biosensor than drug delivery                                approximately $30 million
                                                            vs. 7 to 10 years costing
                                                            more than $100 million

Filing for patent will         Interviewed current patent   TBD - Microneedles
differentiate us from          owner                        combined with integrated
competitors                                                 alert system could be a
                                                            potentially patented product
                                                            at a cost of $20,000 to
                                                            $100,000 taking from 2 to
                                                            15 months
Hypothesis                    Test                  Result

Channels: Direct Sales to
medical device companies       Confirmed by experts   TRUE
is most efficient              in field


Revenue: Revenue stream
is generated through sale of   TBD                    TBD
biosensor as well as
application fees for
integrating with doctor’s
offices
What to do next?? Day 6+
Micro-needle and Micro-chip enabled patch providing periodic monitoring
of anti-coagulant efficacy (prothrombin time).

Data is wirelessly transmitted to patient’s phone and/or to hospital
systems.




  Ensure              Contact               Engage
                                                                 Evaluate
  patent             regulatory            software
                                                                  CMOs
protection           consultant            developer
110 Million People Worldwide At
            Risk of Thrombosis
           Target Market:

• 2,000,000 DVT US patients per
  annum
• $800 for current monthly testing kit
                                         TAM:          SAM:              Target Market:
    • Finger prick test                                                   Medical Device
• Potential insurance cost of              People at                        Suppliers
                                                       DVT occurs in
  $1,600,000,000                             risk
                                                       2,000,000 per
                                              for                            Co vidien
                                                       annum
                                         thrombosis:                     Johnson & Johnson
• $100 for new continuous testing kit                                          Baxter
                                                       600,000 are
• Potential insurance cost of            110 million
                                                       hospitalized w/       Meditronic
                                         worldwide                        Boston Scientific
  $200,000,000                            affected
                                                       DVT/PE
                                                                            Abbott Labs
Marketing approach

  Medical Community                                                Insurance
Medical journal publications
                                                            Results Oriented Data
Key opinion leaders
                                                            Comparative Product Costs
American Society of
                                                            Prevention of Acute Care
Hematology Conferences
                                           Patients         Episodes
Education sessions
                               DVT Awareness Month
                               (March)

                               American Public Health Assoc.

                               Trusted educational online info

                               MD Office
Channels with Capital Flow
                                                                $$
                                                                               Insurance
             $$
                                      $$                        Claim
Regulators                                      Med Device                      $$
                    Bio-Patch                                                            Claim
                                                 Suppliers                Rx
         Approval                 Patch
                                $$ Shipper Patch              Patch            Patient
        Shipper            $$                                        Rx
                                                               $$               $$       Rx
                                                      Pharmacy       Patch
                         CMO                           Network
                                                                                Doctor

                    $$         Needles, Chips

                  Chip / Needle
                   Producers
Getting Customers/Acquisition
“I want to be there for my family. Biopatch
                       helps me monitor my DVT condition so I can
                       worry less and be with my grandchildren”

                                               Meet Dave
                                               Retiree, Grandfather
                                               Age 60+
                                               Former McKinsey
                                               Consultant
                                               Purchases 120
                                               BioPatchs annually

Demographic:                Traits:                      Condition:
•Male/Female Ages           •Loves to travel (for        •Bedridden due to
60+                         business and                 recent hip
                            pleasure) – sitting          replacement (on
Budget:                     down on flights              general
•Fixed Income               •No history of               anesthetic)
•High Insurance             familial cancer or           •Calf
Costs                       thrombosis                   swelling/Localized
•Spends $100 dollars        •Used to be avid             swelling in leg’s
annually on Biopatch        hiker before hip             venuous system
                            injury                       •Weight gain
Day in a life-Remote Monitoring
                 Bio Patch                                  Current
             • On line order                              • On line order
Patient gets • Direct from pharmacy          Patient gets • Direct from pharmacy
 materials                                    materials



                • Peel off adhesive                       • Finger prick
  Patient       • Apply patch                Patient does • Reader with strips
applies patch                                finger prick


             • Electronic results for                     • Electronic read out on device
               immediate use and e-records                • No long term electronic
Patient gets                                 Patient gets
  results    • Call MD office if needed        results      record
Customer Interaction



                         HOSPITAL MONITOR
PATIENT’S MOBILE




           A
Financial Analysis
    After 3 years in market, IRR is roughly 50%, sales
           of $170 mm and net profit of $68 mm
                    Year 0        Year 1        Year 2        Year 3        Year 4       Year 5         Year 6         Year 7
Patent Pending      (100,000)
FDA Approval                     (7,500,000)   (7,500,000)   (7,500,000)   (7,500,000)
Sales                                                                                    59,500,000 110,500,000 170,000,000
Program Expense       (40,000)                                                              (10,000)       (10,000)       (10,000)
App Store Costs                                                                              (1,000)        (1,000)        (1,000)
Mfg / CMO Expense                                                                     $ (27,216,000) $ (50,544,000) $ (77,760,000)
Distribution                                                                                (10,000)       (10,000)       (10,000)
Sales                                                                                      (283,000)      (487,000)      (725,000)
Customer Acq Cost                                                                           (59,500)      (110,500)      (170,000)
Support                                                                                  (8,164,800) (15,163,200) (23,328,000)
Admin                 (60,000)     (25,000)      (25,000)      (25,000)      (25,000)       (75,000)       (75,000)      (100,000)
Total Cash Flows     (200,000)   (7,525,000)   (7,525,000)   (7,525,000)   (7,525,000)   23,680,700    44,099,300      67,896,000


•     Assumes 2 MM patients in its 3rd year (Yr 7 of analysis)
•     Assumes 35% penetration in year 5, 65% penetration in year 6 and 100%
      penetration in year 7 of newly recognized DVT patients
•     Costs are estimates developed through “getting out of the building”
        –   $0.325 for each purchasing and manufacturing of patch after inventory-financing
        –   Outsourced support and service based off of 30% of manufacturing/CMO expenses

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Team m patch aid v5 aug 31

  • 1. Bio-Patch: Team M Microneedle/Microchip Enabled Biosensor Daily Contact Count: 23 Total Contact Count: 49 Joan Affleck Mike Dimitri Kirim Kim John Marshall Matt Nudell
  • 2. Insulin Injection! Wireless Data Transmission!
  • 3. Business Model Canvas Day 1 HP Production Smart drug Inventory Medical delivery Control supply Platform / system – companies networking chip and Co-creation needle Insurance companies HP patent Direct sales CMOs CMOs, Data Data sales team, collection Direct DDS collection general tools sales fees admin
  • 5. Business Model Canvas Day 2 -- Smart drug -- Inventory delivery system Control HP Production Med supply (chip and needle) -- Co-creation companies` -- Personalized Hospitals / doctor Platform / medicine entry -- Branding offices networking Pharma -- Various uses -- Smart delivery companies Insurance Licensing system may -- Personalized companies extend patent life data monitoring Patients -- Ease of use, FDA time mgmt Doctors -- Controlled CMOs pain-free delivery Insurance HP patent Direct sales companies -- Lower patient Cloud service care costs HP -- Purchasing CMOs FDA -- Regulatory CMOs, sales Direct DDS team, general sales admin Data collection Data collection fees tools
  • 6. FDA and PATENT Time and $$???
  • 7. Business Model Canvas Day 3 -- Smart drug -- Inventory Production delivery system Hospitals / doctor Control Med supply (chip and needle) -- Co-creation offices Platform / companies` -- Personalized networking medicine entry -- Branding Pharma Pharma companies -- Various uses Licensing -- Smart delivery companies system may -- Personalized Insurance Procure HP extend patent life data monitoring Patients companies patent -- Ease of use, HP time mgmt Doctors -- Controlled FDA pain-free delivery Insurance HP patent Direct sales companies -- Lower patient CMOs Cloud service care costs BI Application HP -- Purchasing CMOs FDA -- Regulatory CMOs, sales Direct DDS team, general sales admin Data collection Data collection fees tools
  • 9. Business Model Canvas Day 4 Med Device Platform / networking -- Smart drug delivery -- Inventory Companies Software development system Biosensor (chip Control Med Supply / integration and needle) -- Co-creation Device -- Personalized Companies Pharma companies Patent development biomarkers -- Branding -- Clinical Studies Pharma Hospitals / Doctor Companies Procure HP patent -- Smart delivery system offices -- Personalized Production -- Preventative data monitoring Patients Insurance companies healthcare -- Controlled pain-free Hospitals / HP Needle & chip mfg Doctors delivery Software Developer HP patent Insurance -- Lower patient care Direct sales costs Companies Cloud service FDA Patented software Web-based HP -- Purchasing CMOs software Manufacturing download -- Regulatory FDA Hardware costs, CMOs, sales team, general Direct DDS Biosensor sales admin Data collection fees Data collection tools Biosensor customization Application development Software development, patents, legal fees
  • 11. Business Model Canvas Day 5 Med Device Software development Companies Biosensor Med Device / integration Co-creation Companies Personalized biomarkers Pharma companies Patent Filing Clinical Studies Pharma Preventative healthcare Companies Hospitals / Doctor Production Personalized data offices monitoring Patients Lower patient care costs Insurance companies Hospitals / Regulatory Doctors Needle & chip mfg Insurance Software Developer Direct sales Companies Patented software FDA Web-based FDA CMOs Manufacturing software download Hardware costs, CMOs, sales team, general admin Direct Biosensor sales Biosensor customization Software development, patents, legal Application development fees
  • 12. Getting out of the building • Total number of contacts: 49 – Pharma industry subject matter experts in IT, business development, pharmacokinetics, clinical research directors – Medical device experts – Physicians specializing in diabetes, immunology, geriatrics – Life Science consultants – Private equity expert – Venture capital experts – Patients
  • 13. Hypothesis Testing Hypothesis Test Result Micro-needle self- Interviewed Doctors, Board TRUE-Patients dread self application patches are member of Medical Device pricking & inaccurate testing preferred over at-home and Company, Pharmaceutical hospital blood tests Reps and Patients MIXED-Would require proof of concept, safety studies and cost effectiveness FDA regulation period will Interviewed Consultant and TRUE- 510(K), Class II be less rigorous for online research device will take 3 to 5 years, biosensor than drug delivery approximately $30 million vs. 7 to 10 years costing more than $100 million Filing for patent will Interviewed current patent TBD - Microneedles differentiate us from owner combined with integrated competitors alert system could be a potentially patented product at a cost of $20,000 to $100,000 taking from 2 to 15 months
  • 14. Hypothesis Test Result Channels: Direct Sales to medical device companies Confirmed by experts TRUE is most efficient in field Revenue: Revenue stream is generated through sale of TBD TBD biosensor as well as application fees for integrating with doctor’s offices
  • 15. What to do next?? Day 6+ Micro-needle and Micro-chip enabled patch providing periodic monitoring of anti-coagulant efficacy (prothrombin time). Data is wirelessly transmitted to patient’s phone and/or to hospital systems. Ensure Contact Engage Evaluate patent regulatory software CMOs protection consultant developer
  • 16. 110 Million People Worldwide At Risk of Thrombosis Target Market: • 2,000,000 DVT US patients per annum • $800 for current monthly testing kit TAM: SAM: Target Market: • Finger prick test Medical Device • Potential insurance cost of People at Suppliers DVT occurs in $1,600,000,000 risk 2,000,000 per for Co vidien annum thrombosis: Johnson & Johnson • $100 for new continuous testing kit Baxter 600,000 are • Potential insurance cost of 110 million hospitalized w/ Meditronic worldwide Boston Scientific $200,000,000 affected DVT/PE Abbott Labs
  • 17. Marketing approach Medical Community Insurance Medical journal publications Results Oriented Data Key opinion leaders Comparative Product Costs American Society of Prevention of Acute Care Hematology Conferences Patients Episodes Education sessions DVT Awareness Month (March) American Public Health Assoc. Trusted educational online info MD Office
  • 18. Channels with Capital Flow $$ Insurance $$ $$ Claim Regulators Med Device $$ Bio-Patch Claim Suppliers Rx Approval Patch $$ Shipper Patch Patch Patient Shipper $$ Rx $$ $$ Rx Pharmacy Patch CMO Network Doctor $$ Needles, Chips Chip / Needle Producers
  • 20. “I want to be there for my family. Biopatch helps me monitor my DVT condition so I can worry less and be with my grandchildren” Meet Dave Retiree, Grandfather Age 60+ Former McKinsey Consultant Purchases 120 BioPatchs annually Demographic: Traits: Condition: •Male/Female Ages •Loves to travel (for •Bedridden due to 60+ business and recent hip pleasure) – sitting replacement (on Budget: down on flights general •Fixed Income •No history of anesthetic) •High Insurance familial cancer or •Calf Costs thrombosis swelling/Localized •Spends $100 dollars •Used to be avid swelling in leg’s annually on Biopatch hiker before hip venuous system injury •Weight gain
  • 21. Day in a life-Remote Monitoring Bio Patch Current • On line order • On line order Patient gets • Direct from pharmacy Patient gets • Direct from pharmacy materials materials • Peel off adhesive • Finger prick Patient • Apply patch Patient does • Reader with strips applies patch finger prick • Electronic results for • Electronic read out on device immediate use and e-records • No long term electronic Patient gets Patient gets results • Call MD office if needed results record
  • 22. Customer Interaction HOSPITAL MONITOR PATIENT’S MOBILE A
  • 23. Financial Analysis After 3 years in market, IRR is roughly 50%, sales of $170 mm and net profit of $68 mm Year 0 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Patent Pending (100,000) FDA Approval (7,500,000) (7,500,000) (7,500,000) (7,500,000) Sales 59,500,000 110,500,000 170,000,000 Program Expense (40,000) (10,000) (10,000) (10,000) App Store Costs (1,000) (1,000) (1,000) Mfg / CMO Expense $ (27,216,000) $ (50,544,000) $ (77,760,000) Distribution (10,000) (10,000) (10,000) Sales (283,000) (487,000) (725,000) Customer Acq Cost (59,500) (110,500) (170,000) Support (8,164,800) (15,163,200) (23,328,000) Admin (60,000) (25,000) (25,000) (25,000) (25,000) (75,000) (75,000) (100,000) Total Cash Flows (200,000) (7,525,000) (7,525,000) (7,525,000) (7,525,000) 23,680,700 44,099,300 67,896,000 • Assumes 2 MM patients in its 3rd year (Yr 7 of analysis) • Assumes 35% penetration in year 5, 65% penetration in year 6 and 100% penetration in year 7 of newly recognized DVT patients • Costs are estimates developed through “getting out of the building” – $0.325 for each purchasing and manufacturing of patch after inventory-financing – Outsourced support and service based off of 30% of manufacturing/CMO expenses