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MammOptics
Final project presentation for E 245 Winter 2011
MammOptics
  The Team
                 Pedro Hernandez                                  Emma Medjuck
                 BS Chemical Eng., Stanford U.                    BComm Business/Math, McGill U.
                 MS Chemical Eng. (candidate)                     MS MS&E (candidate)
                 Mayfield Fellow 2010



  Brings experience of internship at Pacific        Previous experience with customer
  Biosciences. Numerous courses in                 discovery and customer activities.
  entrepreneurship.


                 Josef Miler                                      Ramin Miri
                 BS Mechanical Eng, MIT                           BS Electrical Eng., Sharif U.
                 MS Mechanical Eng., Stanford U.                  MS Electrical Eng., Stanford U.
                 PhD Mechanical Eng. (candidate)                  MS MS&E, Stanford U.
                                                                  PhD, Electrical Eng. (candidate)


  Technical consulting for start-ups. Expert       PhD research in optical spectroscopy signal
  witness in medtech IP case. Background in IP.    processing. Numerous courses in
                                                   entrepreneurship.
Project overview
     Initial hypotheses

Canvas #1: Finding the right customer
    Testing value proposition
    Purchasing decision tree

Canvas #2: Getting to the customer
    Medical marketing
    Medical sales

Canvas #3: Building the company
    Clinical trials
    Reimbursement
    Financing the company
    Company timeline

Reflection on the company
    Reflection on the medtech industry
    Key industry requirements
    Lessons learned

Appendix
    Financial calculations
    Business model canvas weeks 1-10
Project Overview
Initial industry guesses and customer hypothesis
MammOptics
  Initial Idea

             Breast cancer                            Mammography
   Leading cause of cancer in women            15%-25% false negatives rate
   190,000 diagnosis every year US             25% false positives rate
   41,000 deaths every year US                 Requires X-ray radiation
   Increasing diagnosis rates                  Low resolution



                               MammOptics
                     Novel technology based on RF-
                     modulated optical spectroscopy
                             -  Earlier detection
                             -  Non-radiative
                             -  Non-invasive
MammOptics
   Technology Comparison

                                                            False         False                   Time
                  Risk     Invasiveness   Resolution                              Device Cost
                                                            Pos.          Neg.                  Required


 MammOptics     Very Low     Very Low       <.1 I.I.T.Y.I.W.H.T.K.Y	
  
                                                cm         <15%            5%       15-20k      10 min.



 Mammography     High         High          .6 cm           25%           30%       20-50k      20 min.



     MRI        Medium       Medium         .1 cm           70%            5%       1000k       45 min.



  Ultra-Sound   Very Low     Very Low       >.6 cm         >30%           >40%      5-15k       20 min.
MammOptics
   Business Model Canvas 1 of 4


                   Product                                  Strong clinical
                   Development                              data
                   IP                                       Training
Hospitals
                   Clinical trials                          Maintenance
Leading doctors                                                                 Pioneering
                   FDA                  Radiation-free
3rd party                                                                       radiologists in
                                        Earlier detection
manufacturers                                                                   hospitals
                                        Non-invasive
Distributors

                  IP
                  Leading doctors                           Direct sales to
                  Technical Expertise                       hospitals



       Product Development
       Clinical trials
                                                                Capital equipment sales
       Operating Costs
                                                                and disposable item
MammOptics
   Business Model Canvas 1 of 4


                   Product                               Strong clinical
                   Development                           data
                   IP                                    Training
Hospitals
                   Clinical trials                       Maintenance
Leading doctors                                                              Pioneering
                   FDA               Radiation-free
3rd party                                                                    radiologists in
                                     Earlier detection
manufacturers
                            Test:    Non-invasive                            hospitals

                                         er segment
Distributors
                                  Custom
                                      e proposition to
                  IP
                  Leading doctors Valu         Direct sales
                  Technical Expertise                    hospitals



       Product Development
       Clinical trials
                                                             Capital equipment sales
       Operating Costs
                                                             and disposable item
Finding the right customer
       From radiologists to gynecologists
MammOptics
  Excursions into hospitals

                         Debra Ikeda
     Leading doctors     Jason Davies
                       Jafi Alissa Lipson
                           Sunita Pal

                        6 women >40
        Patients
                        8 women <40


                        Alicia X-ray
       Technicians
                       mammography


        Hospital        Paul Billings
        Managers       Holly V. Gautier
MammOptics
  Hospital purchasing decision tree
MammOptics
  Hospital purchasing decision tree




             Hospitals
                                g decision tree.
             Complex purchasin
             Several saboteours
MammOptics
  Private practice purchasing decision tree
MammOptics
  Private practice purchasing decision tree




                 Private practice
             ✔   Faster adoption rate
                          e value proposition
                 Attractiv
MammOptics
     Business Model Canvas 2 of 4


                      Product              Doctors:            Strong clinical
                      Development          Earlier detection   data
Hospitals (Capital    IP                   Price               Training
Spending              Clinical trials      Accuracy            Maintenance         Pioneering
Committee)            FDA                                                          Doctors
Leading doctors                            Patients:                               Hospitals
3rd party                                  Radiation Free                          OB/GYNs
manufacturers                              Non-Invasive                            PCPs
Distributors                                                   Direct Sales to
                     IP
Research Hospitals                                             doctors
                     Leading doctors
                     Technical Expertise



         Product Development
         Clinical trials                                       Capital Equipment Sales and
         Operating Costs                                       disposable item
MammOptics
     Business Model Canvas 2 of 4


                      Product           Doctors:            Strong clinical
                      Development       Earlier detection   data
Hospitals (Capital    IP                Price               Training
Spending              Clinical trials   Accuracy            Maintenance         Pioneering
Committee)            FDA                                                       Doctors
Leading doctors                         Patients:                               Hospitals

                                                  ur customer?
3rd party                               Radiation Free                          OB/GYNs

                              do we get to o Direct Salescity
manufacturers                           Non-Invasive                            PCPs
                     How
                                              y and specifi to
Distributors
Research Hospitals
                     Leading doctorsnsitivi
                     IP
                               se
                        eedExpertise        t         doctors
                     N
                     Technical



         Product Development
         Clinical trials                                    Capital Equipment Sales and
         Operating Costs                                    disposable item
Getting to our customer
The world of direct sales and medical marketing
MammOptics
  Interviews


      Breast Cancer      Be Bright Pink
     Advocacy Groups    Jennifer Glover

                         Dr. Cindy Woo
        OB/GYNs         Dr. Jags Powers
                       Dr. Aaron Shuvkan

                          Katrina Bell
      Medical Sales     Tanay Dudhela
                          Jed Hwang

       FDA/Clinical     Phyllis Whitely
         Trials         Carl Simpson
MammOptics
  Marketing
                       Key Opinion
                      Leaders (KOLs)

  American College
   of Obstetricians
                                         Medical Journals
  and Gynecologists
       (ACOG)

                       Market
                      Adoption

    Breast Cancer                        Continuing
   Advocacy Groups                     Medical Education


                       Conferences
MammOptics
     Marketing
Strong influence on doctors via
    ACOG Standard of Care              Key	
  Opinion	
  
                                      Leaders	
  (KOLs)	
  
                           Strongly influenced
     American College
      of Obstetricians          by KOLs
                                                                Medical Journals
     and Gynecologists
          (ACOG)


 Access to ACOG by                    Market
  former member                      Adoption
       American College
        of Obstetricians                                        Continuing
       and Gynecologists                                      Medical Education
            (ACOG)

                                       Conferences
MammOptics
  Marketing
          Researchers                                       Researchers with
      conducting important                                    strong peer
          clinical trials          Key	
  Opinion	
        recommendations
                                  Leaders	
  (KOLs)	
  

  American College
               Researchers with
   of Obstetricians                                       Outsourced survey
                  numerous                                          Medical Journals
  and Gynecologists                                           research
                 publications
       (ACOG)

                                   Market
                                  Adoption
   American College
    of Obstetricians                                                Continuing
   and Gynecologists                                              Medical Education
        (ACOG)

                                   Conferences
MammOptics
  Marketing
                                                                Focus on prominent
                        Key	
  Opinion	
                              journals
                       Leaders	
  (KOLs)	
   Need two big
                                         publications
  American College
   of Obstetricians
                                                              Medical Journals
  and Gynecologists
       (ACOG)

                        Market                          Choose KOL as Principal
                       Adoption                            Investigators (PI)

   American College
    of Obstetricians                                          Continuing
   and Gynecologists                                        Medical Education
        (ACOG)

                        Conferences
MammOptics
  Marketing
                        Key	
  Opinion	
  
                       Leaders	
  (KOLs)	
  

  American College
   of Obstetricians
                                                        Medical Journals
  and Gynecologists
       (ACOG)

                        Market                        Effective method for
                                                       educating doctors
                       Adoption
   American College
    of Obstetricians   Workshop must be                 Continuing
   and Gynecologists   approved by ACOG               Medical Education
        (ACOG)

                                Doctors required to
                        Conferences
                                attend workshops          Taught by objective
                                                            medical experts
MammOptics
  Marketing
                              Key	
  Opinion	
  
                             Leaders	
  (KOLs)	
  

  American College
   of Obstetricians
                                                              Medical Journals
  and Gynecologists
       (ACOG)

                              Market
                             Adoption
   American College
    of Obstetricians                                          Continuing
   and Gynecologists                                        Medical Education
        (ACOG)                                        ACOG Annual
           Opportunity for                           Clinical Meeting
           feedback from      Conferences
              doctors
                                                     Miami Breast Cancer
                                                        Conference
MammOptics
      Marketing
                                        Key	
  Opinion	
  
                                       Leaders	
  (KOLs)	
  

      American College
       of Obstetricians
                                                                 Medical Journals
      and Gynecologists
           (ACOG)


Trusted information source             Market
        for patients                  Adoption

         Breast Cancer                                           Continuing
        Advocacy Groups                                        Medical Education
                             Access to media
                                 outlets
                                        Conferences
   Critical opinion leader
  for technology adoption
MammOptics
  Channel Strategies and Costs

 High value medical               Direct Sales                Individual
                                                               Individual
      products                                                  Doctors
                                                                Doctors
   (e.g. cardiovascular
          stents)         •  Doctor education
                          •  Direct feedback from doctors
                          •  Very expensive




Commodity medical                                             Purchasing
                                                              Purchasing
                                  Distributors              Administrators
                                                             Administrators
    products
   (e.g. latex gloves)    •  No doctor education
                          •  No customer feedback
                          •  Inexpensive
MammOptics
  Channel Strategies and Costs


                 Sales strategy 1           Sales strategy 2


             5 dedicated sales people     Continue with core
             $150,000 each/year           group of sales people

             Hire nurses or technicians   Use women’s healthcare
             with established             equipment distributor
             relationships
                                          Already established
             Early adopter feedback       network of customers
MammOptics
   Pricing Strategy

               Equipment   Lease model   Per-use model   Consumable

 Cost of the
                $50,000      $5,000         $5,000         $25,000
   device

Service per     $3,000       $10,000          0              0
   year

Per-use fee        0           0             $50             0


Consumable         0           0              0             $20
MammOptics
                                                         mers
   Pricing Strategy                           db y custo
                                       Approve vestors
                                           and in

               Equipment   Lease model     Per-use model      Consumable

 Cost of the
                $50,000      $5,000            $5,000           $25,000
   device

Service per     $3,000       $10,000             0                0
   year

Per-use fee        0           0                $50               0


Consumable         0           0                 0               $20
MammOptics
  Customer Workflow

                              Insurance
      Current market



                            Mammography           Radiologist




                       Technician            Hospital
                                           Administration



                                    ACOG   Doctor specialty
                                     ACS     committee
MammOptics
  Customer Workflow

                               Insurance
      Current market

      But what would
      happen if we replace
                             Mammography          Radiologist
      mammography?


                        Technician            Hospital
                                            Administration



                                     ACOG   Doctor specialty
                                      ACS     committee
MammOptics
  Customer Workflow

                                Insurance




                              Mammography                Radiologist
   Breast Radiologists      Technicians            Hospitals
                              Loss of jobs     Eliminates loss leader
        Loss of jobs                         Puts emphasis on biopsies
                         Technician                   Hospital
                                                    Administration



                                      ACOG         Doctor specialty
                                       ACS           committee
MammOptics
  Customer Workflow

                       Insurance




                     Mammography          Radiologist




                Technician            Hospital
                                    Administration



                             ACOG   Doctor specialty
                              ACS     committee
MammOptics
  Customer Workflow

                                          Insurance




                                         Mammography                  Radiologist
              Insurance                                  ACOG/ACS
    Same cost as mammography ($140)                  Improved healthcare
    Reduced number of biopsies ($1000)           (mammography weak technique)
                                 Technician                        Hospital
                                                                 Administration



                                               ACOG              Doctor specialty
                                                ACS                committee
MammOptics
  Customer Workflow

                       Insurance




                     Mammography        Radiologist




                Technician            Hospital
                                    Administration



                             ACOG   Doctor specialty
                              ACS     committee
MammOptics
  Customer Workflow

                               Insurance




   Patient      PCP          Mammography        Radiologist
               OB/GYN


                        Technician            Hospital
  MammOptics                                Administration



                                     ACOG   Doctor specialty
                                      ACS     committee
MammOptics
  Customer Workflow

                                        Insurance




   Patient        PCP                 Mammography            Radiologist
        PCP OB/GYNs
                OB/GYN                Patient           MammOptics
        Increased revenue         Improved healthcare      Revenue
    More complete patient care         Comfort
                                 Technician               Hospital
   MammOptics                                           Administration



                                              ACOG      Doctor specialty
                                               ACS        committee
MammOptics
  Customer Workflow

                               Insurance




  Patient       PCP          Mammography         Radiologist
               OB/GYN


                        Technician            Hospital
  MammOptics                                Administration



                                     ACOG   Doctor specialty
                                      ACS     committee
MammOptics
     Business Model Canvas 3 of 4

                      Product                                 Strong clinical
                      Development         Doctors:            data
                      IP                  Earlier detection   Training
                      Clinical trials     Price               Maintenance
Leading doctors       FDA                                     Conferences
Key Opinion Leaders                       Accuracy                                OB/GYNs
                      Publishing                              CME courses         PCPs
3rd party
manufacturers                             Patients:
Distributors                              Radiation Free
Breast Cancer                             Non-Invasive
Foundations                                                   Direct Sales to
                    IP
ACOG                                                          hospitals
                    Leading doctors
ACS                                                           Distributor
                    Technical Expertise



         Product Development
         Clinical trials                                      Capital Equipment Sales and
         Operating Costs                                      disposable item
         Marketing Costs                                      Per use fees
MammOptics
     Business Model Canvas 3 of 4

                      Product                                 Strong clinical
                      Development         Doctors:            data
                      IP                  Earlier detection   Training
                      Clinical trials     Price               Maintenance
Leading doctors       FDA                                     Conferences
Key Opinion Leaders                       Accuracy                                OB/GYNs
                      Reimbursement                           CME courses         PCPs
3rd party             Publishing
manufacturers                             Patients:

                                  e customer
Distributors                              Radiation Free
                                h
                  ow to reach t
Breast Cancer                             Non-Invasive

        Learned h                     Direct Sales d on
                                              seto      this?
                         a company ba
Foundations
                    IP
             do we build
ACOG                                  hospitals
                    Leading doctors
ACS     How                           Distributor
                    Technical Expertise



         Product Development
         Clinical trials                                      Capital Equipment Sales and
         Operating Costs                                      disposable item
         Marketing Costs                                      Per use fees
Building the company
The backstage of a medical device company
MammOptics
  Interviews
                            Stanford Statistics
     FDA Clinical Trials      Steve Axelrod
                             Marga Ortigas-
                                Wedekind

      Manufacturing          Nick Mourlas
                           Don Archambault

                           Shannon Bergstedt
     Reimbursement
                               Ali Habib


         Venture
                              Dana Mead
        Capitalists
                              Bill Starling

      Doctors/Sales        Dr. Aron Shuftan
                              Jed Hwang
                           Michael J. Nohr
MammOptics
  Partners

Manufacturing


                    Choose
                manufacturing
                facility close to
                      home
MammOptics
  Manufacturing Partner

                                                              9 Inches

                                   DSP

                            RFIC
                                                          ~5 lbs
                  Photo probe
                                I.I.T.Y.I.W.H.T.K.Y	
  
                   Disposable head



                     75% gross margin

      COGS
    $4-5k per   Discounts for Revenue Model
       unit
MammOptics
  Technology




                                                  I.I.T.Y.I.W.H.T.K.Y	
  
                         Part                              IP               Development    Manufacturing   COGS
    1     Digital Processing Unit / Algorithms        MammOptics              In-House      Off the Shelf   $200

    2     Customized RF Integrated Circuitry          MammOptics              In-House      Out-Sourced    $500

    3   Probe Bank (Lasers and Photo-Detectors)         Licensed                  -         Off the Shelf   $1500

    4        Disposable Skin Contact Pad              MammOptics              In-House      Out-Sourced     $2

    5                 Packaging                       MammOptics             Out-Sourced    Out-Sourced    $2000
MammOptics
  Partners

Manufacturing                      Reimbursement



                 Difficult to get
                coverage for new
                    product.
MammOptics
  Reimbursement Partners

                           Insurances




  CPT Codes
  $75-$150
MammOptics
  Partners

Manufacturing                      Reimbursement


                  510K vs. PMA
                  Largest cost
                Biggest financial
                      risk



                                     FDA Clinical
                                       Trials
MammOptics
  Clinical Trials




    Stage 1            Feasibility
   Pilot trials     Comparison with
   50 patients       mammography
     $600K


    6 months


                                      12/4/2009
MammOptics
  Clinical Trials


                   Stage 2
                  Interim trials    Prove superior
                                   safety-efficacy &
    Stage 1        500 patients       sensitivity
   Pilot trials       $7.2M




    6 months      15 months


                                                     12/4/2009
MammOptics
  Clinical Trials


                   Stage 2
                  Interim trials
    Stage 1                         Stage 3       FDA class II, 510(K)
   Pilot trials                     FDA pivotal        w/ trials
                                       trials    Focus on superiority
                                   1500 patients   & economic end-
                                      $20.5M            points

    6 months      15 months        24 months


                                                             12/4/2009
MammOptics
  Clinical Trials

                                                     Stage 4
                                                   Post-market
                   Stage 2
                                                     studies
                  Interim trials                   2000 patients
    Stage 1                         Stage 3           $26.8M
   Pilot trials                    FDA pivotal
                                     trials    Specific Cat III CPT/
                                                  ACP Codes
                                                Market traction


    6 months      15 months        24 months          24 months


                                                            12/4/2009
MammOptics
  Clinical Trials

                                                  Stage 4
                                                 Post-market
                   Stage 2
                                                   studies
                  Interim trials
                                                   $26.8M
    Stage 1          $7.2M          Stage 3
   Pilot trials                    FDA pivotal
                                     trials
     $600K
                                     $20.5M


    6 months      15 months        24 months       24 months


                                                        12/4/2009
MammOptics
  Clinical Trials




                    12/4/2009
MammOptics
  Partners

Manufacturing               Reimbursement



                Financial
                timeline


    Funding                   FDA Clinical
                                Trials
MammOptics
                         Financial / Operations Timeline
                                   2012                   2013                     2014                       2015                 2016                     2017                      2018
                             Q1    Q2    Q3   Q4   Q1    Q2      Q3    Q4    Q1    Q2   Q3      Q4   Q1     Q2    Q3   Q4    Q1   Q2     Q3       Q4   Q1   Q2     Q3     Q4    Q1 Q2 / IPO
                                                                                                                                                                                 M&A Q3
                      $40M
                                                                                                                                                   Series D                          $50 MM
                                                                                              Series C
       Cash Reserve




                      $30M

                                                                                             $30.5 MM                                              $35 MM
                      $20M

                      $15M
                                                       Series B $9
                                                           MM
                      $10M
                             Series A
                      $5M    $3.5 MM

                      Initialize
                                                                                        Financial    Regulatory / Clinical                                                  Launch

                       Proof of                              Marketable
                                                                                        timeline
Milestones




                                      Beta Prototype                                             Second Release
                       Concept                                Product
 Design




                                                    Beta-               1st
                              Laboratory                                                                                 2nd Release Test
                                                   Version            Release
                              Prototype            Testing             Test
                                                                                                                                          Publication
                                                                                                Publication
Milestones
 Clinical




                                                    Pilot                                                                              Clinical                         Post-Market Clinical
                                                                            US Interim Trials             US Pivotal Clinical          Results                                Studies
                                                   Studies
                                                                                                                Trials
                                                                                                                                              Non-Specific Codes
                        Provisional
Regulatory/ IP




                          Patent
                                                             IRB /      Cat III                                        FDA – Class II – 510 (k) with                     Specific Codes
 Milestones




                                                              IDE        CPT                                                 Clinical Trials                            (Cat. I CPT / APC)

                                                     IC and            Application                                                                                Initial
                                                   Processing          and System                                                                                Product
                       Technology                    Patents             Patents                                                                                 Launch
                        Licensing                                                                    56                                                                      12/4/2009
MammOptics
                             Financial / Operations Timeline
                                    2012                2013                2014                 2015                2016               2017                2018
                              Q1    Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3
                       $40M
        Cash Reserve




                       $30M

                       $20M

                       $15M

                       $10M

                       $5M




                       Initialize

                        Proof of
 Milestones




                        Concept
  Design
 Milestones
  Clinical




Provisional
 Regulatory/ IP




  Patent
  Milestones




Technology
 Licensing                                                                                 57                                                      12/4/2009
MammOptics
                            Financial / Operations Timeline
                                     2012               2013               2014                 2015                2016               2017                2018
                             Q1    Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3
                      $40M
       Cash Reserve




                      $30M

                      $20M

                      $15M

                      $10M
                             Series A
                      $5M    $3.5 MM

                      Initialize

                       Proof of
Milestones




                       Concept
                                     Beta Prototype
 Design




                              Laboratory           Beta-
                                                  Version
                              Prototype           Testing
Milestones
 Clinical




                                                   Pilot
                                                  Studies



                       Provisional
Regulatory/ IP




                         Patent
 Milestones




                       Technology
                        Licensing
                                                                                          58                                                      12/4/2009
MammOptics
                            Financial / Operations Timeline
                                  2012                 2013                   2014                  2015                   2016               2017                2018
                             Q1   Q2   Q3   Q4   Q1   Q2       Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2    Q3    Q4     Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3
                      $40M
       Cash Reserve




                      $30M

                      $20M

                      $15M
                                                    Series B $9
                                                        MM
                      $10M
                             Series A
                      $5M    $3.5 MM

                                                                                             Regulatory / Clinical

                                                           Marketable
Milestones




                                   Beta Prototype
                                                            Product
 Design




                             Laboratory           Beta-
                                                 Version
                             Prototype           Testing
Milestones
 Clinical




                                                  Pilot
                                                 Studies
Regulatory/ IP




                                                           IRB /
 Milestones




                                                            IDE

                                                   IC and           Application
                                                 Processing         and System
                                                   Patents            Patents
                                                                                             59                                                          12/4/2009
MammOptics
                            Financial / Operations Timeline
                                  2012                 2013                      2014                       2015                 2016               2017                2018
                             Q1   Q2   Q3   Q4   Q1   Q2       Q3    Q4    Q1    Q2   Q3      Q4   Q1     Q2    Q3   Q4    Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3
                      $40M

                                                                                            Series C
       Cash Reserve




                      $30M

                      $20M
                                                                                           $30.5 MM
                      $15M
                                                   Series B $9
                                                       MM
                      $10M

                      $5M




                                                                                                   Regulatory / Clinical
Milestones




                                                                                               Second Release
 Design




                                                                      1st
                                                                    Release
                                                                     Test
                                                                                              Publication
Milestones
 Clinical




                                                  Pilot
                                                                          US Interim Trials             US Pivotal Clinical
                                                 Studies
                                                                                                              Trials
Regulatory/ IP




                                                           IRB /      Cat III
 Milestones




                                                            IDE        CPT

                                                   IC and            Application
                                                 Processing          and System
                                                   Patents             Patents
                                                                                                   60
MammOptics
                            Financial / Operations Timeline
                                  2012                2013                  2014                       2015                 2016                     2017                     2018
                             Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4    Q1    Q2   Q3      Q4   Q1     Q2    Q3   Q4    Q1   Q2     Q3       Q4   Q1   Q2     Q3   Q4      Q1   Q2   Q3
                      $40M

                                                                                       Series C                                             Series D
       Cash Reserve




                      $30M

                                                                                      $30.5 MM                                              $35 MM
                      $20M

                      $15M

                      $10M

                      $5M




                                                                                              Regulatory / Clinical                                                  Launch
Milestones




                                                                                          Second Release
 Design




                                                                                                                  2nd Release Test

                                                                                                                                   Publication
                                                                                         Publication
Milestones
 Clinical




                                                                                                                                Clinical
                                                                     US Interim Trials             US Pivotal Clinical          Results
                                                                                                         Trials
                                                                                                                                       Non-Specific Codes
Regulatory/ IP




                                                                                                                FDA – Class II – 510 (k) with
 Milestones




                                                                                                                      Clinical Trials

                                                                                                                                                           Initial
                                                                                                                                                          Product
                                                                                                                                                          Launch
                                                                                              61                                                                      12/4/2009
MammOptics
                            Financial / Operations Timeline
                                  2012                2013                2014                  2015                   2016                     2017                      2018
                             Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2   Q3   Q4   Q1   Q2    Q3    Q4     Q1   Q2     Q3       Q4   Q1   Q2     Q3     Q4    Q1 Q2 / IPO
                                                                                                                                                                     M&A Q3
                      $40M
                                                                                                                                       Series D                          $50 MM
       Cash Reserve




                      $30M
                                                                                                                                       $35 MM
                      $20M

                      $15M

                      $10M

                      $5M




                                                                                         Regulatory / Clinical                                                  Launch
Milestones
 Design




                                                                                                                              Publication
Milestones
 Clinical




                                                                                                                           Clinical                         Post-Market Clinical
                                                                                                                           Results                                Studies

                                                                                                                                  Non-Specific Codes
Regulatory/ IP




                                                                                                           FDA – Class II – 510 (k) with                     Specific Codes
 Milestones




                                                                                                                 Clinical Trials                            (Cat. I CPT / APC)

                                                                                                                                                      Initial
                                                                                                                                                     Product
                                                                                                                                                     Launch
                                                                                                                                                                 12/4/2009
MammOptics
                            Financial / Operations Timeline
                                   2012                   2013                     2014                       2015                 2016                     2017                      2018
                             Q1    Q2    Q3   Q4   Q1    Q2      Q3    Q4    Q1    Q2   Q3      Q4   Q1     Q2    Q3   Q4    Q1   Q2     Q3       Q4   Q1   Q2     Q3     Q4    Q1 Q2 / IPO
                                                                                                                                                                                 M&A Q3
                      $40M
                                                                                                                                                   Series D                          $50 MM
                                                                                              Series C
       Cash Reserve




                      $30M

                                                                                             $30.5 MM                                              $35 MM
                      $20M

                      $15M
                                                       Series B $9
                                                           MM
                      $10M
                             Series A
                      $5M    $3.5 MM

                      Initialize                                                                     Regulatory / Clinical                                                  Launch

                       Proof of                              Marketable
Milestones




                                      Beta Prototype                                             Second Release
                       Concept                                Product
 Design




                                                    Beta-               1st
                              Laboratory                                                                                 2nd Release Test
                                                   Version            Release
                              Prototype            Testing             Test
                                                                                                                                          Publication
                                                                                                Publication
Milestones
 Clinical




                                                    Pilot                                                                              Clinical                         Post-Market Clinical
                                                                            US Interim Trials             US Pivotal Clinical          Results                                Studies
                                                   Studies
                                                                                                                Trials
                                                                                                                                              Non-Specific Codes
                        Provisional
Regulatory/ IP




                          Patent
                                                             IRB /      Cat III                                        FDA – Class II – 510 (k) with                     Specific Codes
 Milestones




                                                              IDE        CPT                                                 Clinical Trials                            (Cat. I CPT / APC)

                                                     IC and            Application                                                                                Initial
                                                   Processing          and System                                                                                Product
                       Technology                    Patents             Patents                                                                                 Launch
                        Licensing                                                                    63                                                                      12/4/2009
MammOptics
      Business Model Canvas 4 of 4

                         Product                                  Strong clinical
                         Development          Doctors:            data
                         IP                   Earlier detection   Training
                         Clinical trials      Price               Maintenance
KOLs                     FDA                                      Conferences
3rd party                                     Accuracy                              OB/GYNs
                         Reimbursement        Immediate           CME courses       PCPs
manufacturers            Publishing
Distributors                                  Results
Breast Cancer
Foundations                                   Patients:
ACOG                                          Radiation Free
                        IP                    Non-Invasive        Direct Sales to
ACS                                                               hospitals
                        Leading doctors
Clinical trial designer                                           Distributor
                        Technical Expertise
                                                                  Online



          Product Development
          Clinical trials                                         Per use fees
          Operating Costs
          Marketing Costs
MammOptics
      Business Model Canvas 4 of 4

                         Product                                  Strong clinical
                         Development                              data
                         IP                                       Training
                         Clinical trials                          Maintenance
KOLs                     FDA                                      Conferences
3rd party                                     Earlier detection                     OB/GYNs
                         Reimbursement        Non invasive        CME courses       PCPs
manufacturers            Publishing
Breast Cancer                                 Price

                                     iness model
Foundations                                   Accuracy

                      ion of our bus
ACOG                                          Immediate Results

         Final iterat                   Direct Sales to ic tu
                                              b ig p          re…
                              nk about the
ACS
                        IP
                            i
             … need to th
Clinical trial designer                 hospitals
                        Leading doctors
         But                            Distributor
                        Technical Expertise
                                                                  Online



          Product Development
          Clinical trials                                         Per use fees
          Operating Costs
          Marketing Costs
Reflection on the Company
Lessons learned from the medical device industry
MammOptics
  Fundamental Challenges of a Medtech Startup
                      Reimbursement



    FDA approval
                                      Medical
                                      technology



       Intellectual
       Property
MammOptics
  Fundamental Challenges of a Medtech Startup
                          Reimbursement
      Capital intensive
                                          Long time to
                                          market
    FDA approval
                                          Medical
                                          technology
 Profitability
 networks
                                  Dependence
       Intellectual               on KOLs
       Property
MammOptics
  Fundamental Challenges of a Medtech Startup
                          Reimbursement
      Capital intensive
                                          Long time to
                                          market
    FDA approval
                                          Medical
                                          technology
 Profitability
 networks
                                  Dependence
       Intellectual               on KOLs
       Property
Gives freedom to
operate

Intellectual       Creates entry barrier
Property           for competitors
Near 50 interviews
                                Around 50 hrs/week



Special thanks to our mentors
     Rowan Chapman              Thank you…
         Steve Turner           Business Model Recap
        Jason Davies
MammOptics
   Business Model Canvas 1


                   Product                                  Strong clinical
                   Development                              data
                   IP                                       Training
Hospitals
                   Clinical trials      Radiation-free      Maintenance         Pioneering
Leading doctors
                   FDA                  Earlier detection                       Doctors
3rd party
                                        Non invasive                            Hospitals
manufacturers
Distributors

                  IP                                        Direct Sales to
                  Leading doctors                           hospitals
                  Technical Expertise



       Product Development
       Clinical trials                                      Capital Equipment Sales and
       Operating Costs                                      disposable item
MammOptics
     Business Model Canvas 2


                      Product                                  Strong clinical
                      Development                              data
                      IP                                       Training
                      Clinical trials      Radiation-free      Maintenance         Pioneering
Hospitals
                      FDA                  Earlier detection                       Doctors
Leading doctors
                                           Non invasive                            Hospitals
3rd party
manufacturers
Distributors
Research Hospitals   IP                                        Direct Sales to
                     Leading doctors                           hospitals
                     Technical Expertise



         Product Development
         Clinical trials                                       Capital Equipment Sales and
         Operating Costs                                       disposable item
MammOptics
     Business Model Canvas 3


                      Product              Doctors:            Strong clinical
                      Development          Earlier detection   data
Hospitals (Capital    IP                   Price               Training
Spending              Clinical trials      Accuracy            Maintenance         Pioneering
Committee)            FDA                                                          Doctors
Leading doctors                            Patients:                               Hospitals
3rd party                                  Radiation Free
manufacturers                              Non-Invasive
Distributors                                                   Direct Sales to
                     IP
Research Hospitals                                             hospitals
                     Leading doctors
                     Technical Expertise



         Product Development
         Clinical trials                                       Capital Equipment Sales and
         Operating Costs                                       disposable item
MammOptics
     Business Model Canvas 4


                      Product              Doctors:            Strong clinical
                      Development          Earlier detection   data
Hospitals (Capital    IP                   Price               Training
Spending              Clinical trials      Accuracy            Maintenance         Pioneering
Committee)            FDA                  Immediate                               Doctors
Leading doctors                            Results                                 Hospitals
3rd party                                                                          OB/GYNs
manufacturers                              Patients:                               PCPs
Distributors                               Radiation Free
                     IP                    Non-Invasive        Direct Sales to
Research Hospitals                                             hospitals
                     Leading doctors
Breast Cancer
                     Technical Expertise
Foundations



         Product Development
         Clinical trials                                       Capital Equipment Sales and
         Operating Costs                                       disposable item
MammOptics
     Business Model Canvas 5

                      Product                                 Strong clinical
                      Development         Doctors:            data
                      IP                  Earlier detection   Training
                      Clinical trials     Price               Maintenance
Leading doctors       FDA                                     Conferences
Key Opinion Leaders                       Accuracy                                OB/GYNs
                      Reimbursement                           CME courses         PCPs
3rd party             Publishing
manufacturers                             Patients:
Distributors                              Radiation Free
Breast Cancer                             Non-Invasive
Foundations                                                   Direct Sales to
                    IP
ACOG                                                          hospitals
                    Leading doctors
ACS                                                           Distributor
                    Technical Expertise



         Product Development
         Clinical trials                                      Capital Equipment Sales and
         Operating Costs                                      disposable item
         Marketing Costs
MammOptics
     Business Model Canvas 6

                    Product                                 Strong clinical
                    Development         Doctors:            data
                    IP                  Earlier detection   Training
                    Clinical trials     Price               Maintenance
KOLs                FDA                                     Conferences
3rd party                               Accuracy                                OB/GYNs
                    Reimbursement       Immediate           CME courses         PCPs
manufacturers       Publishing
Distributors                            Results
Breast Cancer
Foundations                             Patients:
ACOG                                    Radiation Free
                  IP                    Non-Invasive        Direct Sales to
ACS                                                         hospitals
                  Leading doctors
                  Technical Expertise                       Distributor




        Product Development
        Clinical trials                                     Capital Equipment Sales and
        Operating Costs                                     disposable item
        Marketing Costs                                     Per use fees
MammOptics
      Business Model Canvas 7

                         Product                                  Strong clinical
                         Development          Doctors:            data
                         IP                   Earlier detection   Training
                         Clinical trials      Price               Maintenance
KOLs                     FDA                                      Conferences
3rd party                                     Accuracy                              OB/GYNs
                         Reimbursement        Immediate           CME courses       PCPs
manufacturers            Publishing
Distributors                                  Results
Breast Cancer
Foundations                                   Patients:
ACOG                                          Radiation Free
                        IP                    Non-Invasive        Direct Sales to
ACS                                                               hospitals
                        Leading doctors
Clinical trial designer                                           Distributor
                        Technical Expertise



          Product Development
          Clinical trials                                         Per use fees
          Operating Costs
          Marketing Costs
MammOptics
      Business Model Canvas 8

                         Product                                  Strong clinical
                         Development          Doctors:            data
                         IP                   Earlier detection   Training
                         Clinical trials      Price               Maintenance
KOLs                     FDA                                      Conferences
3rd party                                     Accuracy                              OB/GYNs
                         Reimbursement        Immediate           CME courses       PCPs
manufacturers            Publishing
(local)                                       Results
Breast Cancer
Foundations                                   Patients:
ACOG                                          Radiation Free
                        IP                    Non-Invasive        Direct Sales to
ACS                                                               hospitals
                        Leading doctors
Clinical trial designer                                           Distributor
                        Technical Expertise



          Product Development
          Clinical trials                                         Per use fees
          Operating Costs
          Marketing Costs
MammOptics
      Business Model Canvas 9

                         Product                                  Strong clinical
                         Development          Doctors:            data
                         IP                   Earlier detection   Training
                         Clinical trials      Price               Maintenance
KOLs                     FDA                                      Conferences
3rd party                                     Accuracy                              OB/GYNs
                         Reimbursement        Immediate           CME courses       PCPs
manufacturers            Publishing
(local)                                       Results
Breast Cancer
Foundations                                   Patients:
ACOG                                          Radiation Free
                        IP                    Non-Invasive        Direct Sales to
ACS                                                               hospitals
                        Leading doctors
Clinical trial designer                                           Distributor
                        Technical Expertise



          Product Development
          Clinical trials                                         Per use fees
          Operating Costs
          Marketing Costs
Mammoptics E245 Final Presentation
MammOptics
    Operations Stack




Head Count 11   20   30   36   50   59   66
MammOptics
  Financial Assumptions


                                       •  Gain	
  support	
  of	
  private	
  insurance	
  
    CPT	
  Code	
  Finalized	
  
                                       •  Greater	
  market	
  trac@on	
  

  Market	
  adop@on	
  rate	
  
  modeled	
  aKer	
  	
  Cytyc’s	
     •  Similar	
  demographic,	
  procedure	
  count	
  
       ThinPrep	
  

     Steady	
  growth	
  of	
          •  Begin	
  at	
  2,500/device	
  
     procedure	
  count	
              •  4,000/device	
  average	
  mammograms	
  

   Priced	
  for	
  75%	
  gross	
     •  ThinPrep	
  78%	
  gross	
  margin	
  
            margin	
                   •  Typical	
  in	
  medtech	
  industries	
  
MammOptics
           Post-Launch Revenue Projection

$250,000,000	
  




$200,000,000	
  




$150,000,000	
  


                                                                                                                                7,300,000 procedures
                                                                                                                                    4,000 devices
$100,000,000	
  

                                                                               75% of revenue comes from
                                                                       3,300,000 procedures
                                                                               per-use model revenue
                                                                        1,900 devices
 $50,000,000	
  
                     800,000 procedures
                      800 devices

            $0	
  
                          	
  2018           	
        	
                        	
  2019   	
                      	
                      	
  2020	
  
                           Forecasted	
  Revenue	
            Forecasted	
  COGS	
          Proxy	
  (Cytyc)	
  Revenue	
  AKer	
  Support	
  from	
  Insurance	
  
MammOptics
     Proxy Margins Comparison

                                            MammOp@cs	
         	
     Cytyc,	
  Year	
  2000	
  
                                            Steady	
  State	
            Steady	
  State   	
  
   Revenue	
         	
                         $75.6M	
  
                                                      	
                    $142.1M	
  
    Cost	
  of	
  
                                                $18.9M	
  
                                                      	
                     $24.6M	
  
   Revenue	
         	
  
 Gross	
  Margin	
                   	
         75%	
  	
                   83%   	
  
 Engineering	
                  	
          $5.3M	
  (13%)	
  
                                                            	
          $14.2M	
  (10%)	
  
   Sales	
  and	
  
                                            $26.5M	
  (35%)	
  
                                                           	
           $55.2M	
  (39%)
                                                                                      	
  
  Marke7ng	
              	
  
     G	
  &	
  A	
                           $3.0M	
  (7%)	
  
                                                            	
          $13.9M	
  (10%)	
  
  Net	
  Margin	
             	
                19%	
  	
                   24%   	
  

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Mammoptics E245 Final Presentation

  • 2. MammOptics The Team Pedro Hernandez Emma Medjuck BS Chemical Eng., Stanford U. BComm Business/Math, McGill U. MS Chemical Eng. (candidate) MS MS&E (candidate) Mayfield Fellow 2010 Brings experience of internship at Pacific Previous experience with customer Biosciences. Numerous courses in discovery and customer activities. entrepreneurship. Josef Miler Ramin Miri BS Mechanical Eng, MIT BS Electrical Eng., Sharif U. MS Mechanical Eng., Stanford U. MS Electrical Eng., Stanford U. PhD Mechanical Eng. (candidate) MS MS&E, Stanford U. PhD, Electrical Eng. (candidate) Technical consulting for start-ups. Expert PhD research in optical spectroscopy signal witness in medtech IP case. Background in IP. processing. Numerous courses in entrepreneurship.
  • 3. Project overview Initial hypotheses Canvas #1: Finding the right customer Testing value proposition Purchasing decision tree Canvas #2: Getting to the customer Medical marketing Medical sales Canvas #3: Building the company Clinical trials Reimbursement Financing the company Company timeline Reflection on the company Reflection on the medtech industry Key industry requirements Lessons learned Appendix Financial calculations Business model canvas weeks 1-10
  • 4. Project Overview Initial industry guesses and customer hypothesis
  • 5. MammOptics Initial Idea Breast cancer Mammography Leading cause of cancer in women 15%-25% false negatives rate 190,000 diagnosis every year US 25% false positives rate 41,000 deaths every year US Requires X-ray radiation Increasing diagnosis rates Low resolution MammOptics Novel technology based on RF- modulated optical spectroscopy -  Earlier detection -  Non-radiative -  Non-invasive
  • 6. MammOptics Technology Comparison False False Time Risk Invasiveness Resolution Device Cost Pos. Neg. Required MammOptics Very Low Very Low <.1 I.I.T.Y.I.W.H.T.K.Y   cm <15% 5% 15-20k 10 min. Mammography High High .6 cm 25% 30% 20-50k 20 min. MRI Medium Medium .1 cm 70% 5% 1000k 45 min. Ultra-Sound Very Low Very Low >.6 cm >30% >40% 5-15k 20 min.
  • 7. MammOptics Business Model Canvas 1 of 4 Product Strong clinical Development data IP Training Hospitals Clinical trials Maintenance Leading doctors Pioneering FDA Radiation-free 3rd party radiologists in Earlier detection manufacturers hospitals Non-invasive Distributors IP Leading doctors Direct sales to Technical Expertise hospitals Product Development Clinical trials Capital equipment sales Operating Costs and disposable item
  • 8. MammOptics Business Model Canvas 1 of 4 Product Strong clinical Development data IP Training Hospitals Clinical trials Maintenance Leading doctors Pioneering FDA Radiation-free 3rd party radiologists in Earlier detection manufacturers Test: Non-invasive hospitals er segment Distributors Custom e proposition to IP Leading doctors Valu Direct sales Technical Expertise hospitals Product Development Clinical trials Capital equipment sales Operating Costs and disposable item
  • 9. Finding the right customer From radiologists to gynecologists
  • 10. MammOptics Excursions into hospitals Debra Ikeda Leading doctors Jason Davies Jafi Alissa Lipson Sunita Pal 6 women >40 Patients 8 women <40 Alicia X-ray Technicians mammography Hospital Paul Billings Managers Holly V. Gautier
  • 11. MammOptics Hospital purchasing decision tree
  • 12. MammOptics Hospital purchasing decision tree Hospitals g decision tree. Complex purchasin Several saboteours
  • 13. MammOptics Private practice purchasing decision tree
  • 14. MammOptics Private practice purchasing decision tree Private practice ✔ Faster adoption rate e value proposition Attractiv
  • 15. MammOptics Business Model Canvas 2 of 4 Product Doctors: Strong clinical Development Earlier detection data Hospitals (Capital IP Price Training Spending Clinical trials Accuracy Maintenance Pioneering Committee) FDA Doctors Leading doctors Patients: Hospitals 3rd party Radiation Free OB/GYNs manufacturers Non-Invasive PCPs Distributors Direct Sales to IP Research Hospitals doctors Leading doctors Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item
  • 16. MammOptics Business Model Canvas 2 of 4 Product Doctors: Strong clinical Development Earlier detection data Hospitals (Capital IP Price Training Spending Clinical trials Accuracy Maintenance Pioneering Committee) FDA Doctors Leading doctors Patients: Hospitals ur customer? 3rd party Radiation Free OB/GYNs do we get to o Direct Salescity manufacturers Non-Invasive PCPs How y and specifi to Distributors Research Hospitals Leading doctorsnsitivi IP se eedExpertise t doctors N Technical Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item
  • 17. Getting to our customer The world of direct sales and medical marketing
  • 18. MammOptics Interviews Breast Cancer Be Bright Pink Advocacy Groups Jennifer Glover Dr. Cindy Woo OB/GYNs Dr. Jags Powers Dr. Aaron Shuvkan Katrina Bell Medical Sales Tanay Dudhela Jed Hwang FDA/Clinical Phyllis Whitely Trials Carl Simpson
  • 19. MammOptics Marketing Key Opinion Leaders (KOLs) American College of Obstetricians Medical Journals and Gynecologists (ACOG) Market Adoption Breast Cancer Continuing Advocacy Groups Medical Education Conferences
  • 20. MammOptics Marketing Strong influence on doctors via ACOG Standard of Care Key  Opinion   Leaders  (KOLs)   Strongly influenced American College of Obstetricians by KOLs Medical Journals and Gynecologists (ACOG) Access to ACOG by Market former member Adoption American College of Obstetricians Continuing and Gynecologists Medical Education (ACOG) Conferences
  • 21. MammOptics Marketing Researchers Researchers with conducting important strong peer clinical trials Key  Opinion   recommendations Leaders  (KOLs)   American College Researchers with of Obstetricians Outsourced survey numerous Medical Journals and Gynecologists research publications (ACOG) Market Adoption American College of Obstetricians Continuing and Gynecologists Medical Education (ACOG) Conferences
  • 22. MammOptics Marketing Focus on prominent Key  Opinion   journals Leaders  (KOLs)   Need two big publications American College of Obstetricians Medical Journals and Gynecologists (ACOG) Market Choose KOL as Principal Adoption Investigators (PI) American College of Obstetricians Continuing and Gynecologists Medical Education (ACOG) Conferences
  • 23. MammOptics Marketing Key  Opinion   Leaders  (KOLs)   American College of Obstetricians Medical Journals and Gynecologists (ACOG) Market Effective method for educating doctors Adoption American College of Obstetricians Workshop must be Continuing and Gynecologists approved by ACOG Medical Education (ACOG) Doctors required to Conferences attend workshops Taught by objective medical experts
  • 24. MammOptics Marketing Key  Opinion   Leaders  (KOLs)   American College of Obstetricians Medical Journals and Gynecologists (ACOG) Market Adoption American College of Obstetricians Continuing and Gynecologists Medical Education (ACOG) ACOG Annual Opportunity for Clinical Meeting feedback from Conferences doctors Miami Breast Cancer Conference
  • 25. MammOptics Marketing Key  Opinion   Leaders  (KOLs)   American College of Obstetricians Medical Journals and Gynecologists (ACOG) Trusted information source Market for patients Adoption Breast Cancer Continuing Advocacy Groups Medical Education Access to media outlets Conferences Critical opinion leader for technology adoption
  • 26. MammOptics Channel Strategies and Costs High value medical Direct Sales Individual Individual products Doctors Doctors (e.g. cardiovascular stents) •  Doctor education •  Direct feedback from doctors •  Very expensive Commodity medical Purchasing Purchasing Distributors Administrators Administrators products (e.g. latex gloves) •  No doctor education •  No customer feedback •  Inexpensive
  • 27. MammOptics Channel Strategies and Costs Sales strategy 1 Sales strategy 2 5 dedicated sales people Continue with core $150,000 each/year group of sales people Hire nurses or technicians Use women’s healthcare with established equipment distributor relationships Already established Early adopter feedback network of customers
  • 28. MammOptics Pricing Strategy Equipment Lease model Per-use model Consumable Cost of the $50,000 $5,000 $5,000 $25,000 device Service per $3,000 $10,000 0 0 year Per-use fee 0 0 $50 0 Consumable 0 0 0 $20
  • 29. MammOptics mers Pricing Strategy db y custo Approve vestors and in Equipment Lease model Per-use model Consumable Cost of the $50,000 $5,000 $5,000 $25,000 device Service per $3,000 $10,000 0 0 year Per-use fee 0 0 $50 0 Consumable 0 0 0 $20
  • 30. MammOptics Customer Workflow Insurance Current market Mammography Radiologist Technician Hospital Administration ACOG Doctor specialty ACS committee
  • 31. MammOptics Customer Workflow Insurance Current market But what would happen if we replace Mammography Radiologist mammography? Technician Hospital Administration ACOG Doctor specialty ACS committee
  • 32. MammOptics Customer Workflow Insurance Mammography Radiologist Breast Radiologists Technicians Hospitals Loss of jobs Eliminates loss leader Loss of jobs Puts emphasis on biopsies Technician Hospital Administration ACOG Doctor specialty ACS committee
  • 33. MammOptics Customer Workflow Insurance Mammography Radiologist Technician Hospital Administration ACOG Doctor specialty ACS committee
  • 34. MammOptics Customer Workflow Insurance Mammography Radiologist Insurance ACOG/ACS Same cost as mammography ($140) Improved healthcare Reduced number of biopsies ($1000) (mammography weak technique) Technician Hospital Administration ACOG Doctor specialty ACS committee
  • 35. MammOptics Customer Workflow Insurance Mammography Radiologist Technician Hospital Administration ACOG Doctor specialty ACS committee
  • 36. MammOptics Customer Workflow Insurance Patient PCP Mammography Radiologist OB/GYN Technician Hospital MammOptics Administration ACOG Doctor specialty ACS committee
  • 37. MammOptics Customer Workflow Insurance Patient PCP Mammography Radiologist PCP OB/GYNs OB/GYN Patient MammOptics Increased revenue Improved healthcare Revenue More complete patient care Comfort Technician Hospital MammOptics Administration ACOG Doctor specialty ACS committee
  • 38. MammOptics Customer Workflow Insurance Patient PCP Mammography Radiologist OB/GYN Technician Hospital MammOptics Administration ACOG Doctor specialty ACS committee
  • 39. MammOptics Business Model Canvas 3 of 4 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance Leading doctors FDA Conferences Key Opinion Leaders Accuracy OB/GYNs Publishing CME courses PCPs 3rd party manufacturers Patients: Distributors Radiation Free Breast Cancer Non-Invasive Foundations Direct Sales to IP ACOG hospitals Leading doctors ACS Distributor Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item Marketing Costs Per use fees
  • 40. MammOptics Business Model Canvas 3 of 4 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance Leading doctors FDA Conferences Key Opinion Leaders Accuracy OB/GYNs Reimbursement CME courses PCPs 3rd party Publishing manufacturers Patients: e customer Distributors Radiation Free h ow to reach t Breast Cancer Non-Invasive Learned h Direct Sales d on seto this? a company ba Foundations IP do we build ACOG hospitals Leading doctors ACS How Distributor Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item Marketing Costs Per use fees
  • 41. Building the company The backstage of a medical device company
  • 42. MammOptics Interviews Stanford Statistics FDA Clinical Trials Steve Axelrod Marga Ortigas- Wedekind Manufacturing Nick Mourlas Don Archambault Shannon Bergstedt Reimbursement Ali Habib Venture Dana Mead Capitalists Bill Starling Doctors/Sales Dr. Aron Shuftan Jed Hwang Michael J. Nohr
  • 43. MammOptics Partners Manufacturing Choose manufacturing facility close to home
  • 44. MammOptics Manufacturing Partner 9 Inches DSP RFIC ~5 lbs Photo probe I.I.T.Y.I.W.H.T.K.Y   Disposable head 75% gross margin COGS $4-5k per Discounts for Revenue Model unit
  • 45. MammOptics Technology I.I.T.Y.I.W.H.T.K.Y   Part IP Development Manufacturing COGS 1 Digital Processing Unit / Algorithms MammOptics In-House Off the Shelf $200 2 Customized RF Integrated Circuitry MammOptics In-House Out-Sourced $500 3 Probe Bank (Lasers and Photo-Detectors) Licensed - Off the Shelf $1500 4 Disposable Skin Contact Pad MammOptics In-House Out-Sourced $2 5 Packaging MammOptics Out-Sourced Out-Sourced $2000
  • 46. MammOptics Partners Manufacturing Reimbursement Difficult to get coverage for new product.
  • 47. MammOptics Reimbursement Partners Insurances CPT Codes $75-$150
  • 48. MammOptics Partners Manufacturing Reimbursement 510K vs. PMA Largest cost Biggest financial risk FDA Clinical Trials
  • 49. MammOptics Clinical Trials Stage 1 Feasibility Pilot trials Comparison with 50 patients mammography $600K 6 months 12/4/2009
  • 50. MammOptics Clinical Trials Stage 2 Interim trials Prove superior safety-efficacy & Stage 1 500 patients sensitivity Pilot trials $7.2M 6 months 15 months 12/4/2009
  • 51. MammOptics Clinical Trials Stage 2 Interim trials Stage 1 Stage 3 FDA class II, 510(K) Pilot trials FDA pivotal w/ trials trials Focus on superiority 1500 patients & economic end- $20.5M points 6 months 15 months 24 months 12/4/2009
  • 52. MammOptics Clinical Trials Stage 4 Post-market Stage 2 studies Interim trials 2000 patients Stage 1 Stage 3 $26.8M Pilot trials FDA pivotal trials Specific Cat III CPT/ ACP Codes Market traction 6 months 15 months 24 months 24 months 12/4/2009
  • 53. MammOptics Clinical Trials Stage 4 Post-market Stage 2 studies Interim trials $26.8M Stage 1 $7.2M Stage 3 Pilot trials FDA pivotal trials $600K $20.5M 6 months 15 months 24 months 24 months 12/4/2009
  • 54. MammOptics Clinical Trials 12/4/2009
  • 55. MammOptics Partners Manufacturing Reimbursement Financial timeline Funding FDA Clinical Trials
  • 56. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 / IPO M&A Q3 $40M Series D $50 MM Series C Cash Reserve $30M $30.5 MM $35 MM $20M $15M Series B $9 MM $10M Series A $5M $3.5 MM Initialize Financial Regulatory / Clinical Launch Proof of Marketable timeline Milestones Beta Prototype Second Release Concept Product Design Beta- 1st Laboratory 2nd Release Test Version Release Prototype Testing Test Publication Publication Milestones Clinical Pilot Clinical Post-Market Clinical US Interim Trials US Pivotal Clinical Results Studies Studies Trials Non-Specific Codes Provisional Regulatory/ IP Patent IRB / Cat III FDA – Class II – 510 (k) with Specific Codes Milestones IDE CPT Clinical Trials (Cat. I CPT / APC) IC and Application Initial Processing and System Product Technology Patents Patents Launch Licensing 56 12/4/2009
  • 57. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Cash Reserve $30M $20M $15M $10M $5M Initialize Proof of Milestones Concept Design Milestones Clinical Provisional Regulatory/ IP Patent Milestones Technology Licensing 57 12/4/2009
  • 58. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Cash Reserve $30M $20M $15M $10M Series A $5M $3.5 MM Initialize Proof of Milestones Concept Beta Prototype Design Laboratory Beta- Version Prototype Testing Milestones Clinical Pilot Studies Provisional Regulatory/ IP Patent Milestones Technology Licensing 58 12/4/2009
  • 59. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Cash Reserve $30M $20M $15M Series B $9 MM $10M Series A $5M $3.5 MM Regulatory / Clinical Marketable Milestones Beta Prototype Product Design Laboratory Beta- Version Prototype Testing Milestones Clinical Pilot Studies Regulatory/ IP IRB / Milestones IDE IC and Application Processing and System Patents Patents 59 12/4/2009
  • 60. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Series C Cash Reserve $30M $20M $30.5 MM $15M Series B $9 MM $10M $5M Regulatory / Clinical Milestones Second Release Design 1st Release Test Publication Milestones Clinical Pilot US Interim Trials US Pivotal Clinical Studies Trials Regulatory/ IP IRB / Cat III Milestones IDE CPT IC and Application Processing and System Patents Patents 60
  • 61. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 $40M Series C Series D Cash Reserve $30M $30.5 MM $35 MM $20M $15M $10M $5M Regulatory / Clinical Launch Milestones Second Release Design 2nd Release Test Publication Publication Milestones Clinical Clinical US Interim Trials US Pivotal Clinical Results Trials Non-Specific Codes Regulatory/ IP FDA – Class II – 510 (k) with Milestones Clinical Trials Initial Product Launch 61 12/4/2009
  • 62. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 / IPO M&A Q3 $40M Series D $50 MM Cash Reserve $30M $35 MM $20M $15M $10M $5M Regulatory / Clinical Launch Milestones Design Publication Milestones Clinical Clinical Post-Market Clinical Results Studies Non-Specific Codes Regulatory/ IP FDA – Class II – 510 (k) with Specific Codes Milestones Clinical Trials (Cat. I CPT / APC) Initial Product Launch 12/4/2009
  • 63. MammOptics Financial / Operations Timeline 2012 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 / IPO M&A Q3 $40M Series D $50 MM Series C Cash Reserve $30M $30.5 MM $35 MM $20M $15M Series B $9 MM $10M Series A $5M $3.5 MM Initialize Regulatory / Clinical Launch Proof of Marketable Milestones Beta Prototype Second Release Concept Product Design Beta- 1st Laboratory 2nd Release Test Version Release Prototype Testing Test Publication Publication Milestones Clinical Pilot Clinical Post-Market Clinical US Interim Trials US Pivotal Clinical Results Studies Studies Trials Non-Specific Codes Provisional Regulatory/ IP Patent IRB / Cat III FDA – Class II – 510 (k) with Specific Codes Milestones IDE CPT Clinical Trials (Cat. I CPT / APC) IC and Application Initial Processing and System Product Technology Patents Patents Launch Licensing 63 12/4/2009
  • 64. MammOptics Business Model Canvas 4 of 4 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance KOLs FDA Conferences 3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPs manufacturers Publishing Distributors Results Breast Cancer Foundations Patients: ACOG Radiation Free IP Non-Invasive Direct Sales to ACS hospitals Leading doctors Clinical trial designer Distributor Technical Expertise Online Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  • 65. MammOptics Business Model Canvas 4 of 4 Product Strong clinical Development data IP Training Clinical trials Maintenance KOLs FDA Conferences 3rd party Earlier detection OB/GYNs Reimbursement Non invasive CME courses PCPs manufacturers Publishing Breast Cancer Price iness model Foundations Accuracy ion of our bus ACOG Immediate Results Final iterat Direct Sales to ic tu b ig p re… nk about the ACS IP i … need to th Clinical trial designer hospitals Leading doctors But Distributor Technical Expertise Online Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  • 66. Reflection on the Company Lessons learned from the medical device industry
  • 67. MammOptics Fundamental Challenges of a Medtech Startup Reimbursement FDA approval Medical technology Intellectual Property
  • 68. MammOptics Fundamental Challenges of a Medtech Startup Reimbursement Capital intensive Long time to market FDA approval Medical technology Profitability networks Dependence Intellectual on KOLs Property
  • 69. MammOptics Fundamental Challenges of a Medtech Startup Reimbursement Capital intensive Long time to market FDA approval Medical technology Profitability networks Dependence Intellectual on KOLs Property
  • 70. Gives freedom to operate Intellectual Creates entry barrier Property for competitors
  • 71. Near 50 interviews Around 50 hrs/week Special thanks to our mentors Rowan Chapman Thank you… Steve Turner Business Model Recap Jason Davies
  • 72. MammOptics Business Model Canvas 1 Product Strong clinical Development data IP Training Hospitals Clinical trials Radiation-free Maintenance Pioneering Leading doctors FDA Earlier detection Doctors 3rd party Non invasive Hospitals manufacturers Distributors IP Direct Sales to Leading doctors hospitals Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item
  • 73. MammOptics Business Model Canvas 2 Product Strong clinical Development data IP Training Clinical trials Radiation-free Maintenance Pioneering Hospitals FDA Earlier detection Doctors Leading doctors Non invasive Hospitals 3rd party manufacturers Distributors Research Hospitals IP Direct Sales to Leading doctors hospitals Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item
  • 74. MammOptics Business Model Canvas 3 Product Doctors: Strong clinical Development Earlier detection data Hospitals (Capital IP Price Training Spending Clinical trials Accuracy Maintenance Pioneering Committee) FDA Doctors Leading doctors Patients: Hospitals 3rd party Radiation Free manufacturers Non-Invasive Distributors Direct Sales to IP Research Hospitals hospitals Leading doctors Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item
  • 75. MammOptics Business Model Canvas 4 Product Doctors: Strong clinical Development Earlier detection data Hospitals (Capital IP Price Training Spending Clinical trials Accuracy Maintenance Pioneering Committee) FDA Immediate Doctors Leading doctors Results Hospitals 3rd party OB/GYNs manufacturers Patients: PCPs Distributors Radiation Free IP Non-Invasive Direct Sales to Research Hospitals hospitals Leading doctors Breast Cancer Technical Expertise Foundations Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item
  • 76. MammOptics Business Model Canvas 5 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance Leading doctors FDA Conferences Key Opinion Leaders Accuracy OB/GYNs Reimbursement CME courses PCPs 3rd party Publishing manufacturers Patients: Distributors Radiation Free Breast Cancer Non-Invasive Foundations Direct Sales to IP ACOG hospitals Leading doctors ACS Distributor Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item Marketing Costs
  • 77. MammOptics Business Model Canvas 6 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance KOLs FDA Conferences 3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPs manufacturers Publishing Distributors Results Breast Cancer Foundations Patients: ACOG Radiation Free IP Non-Invasive Direct Sales to ACS hospitals Leading doctors Technical Expertise Distributor Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item Marketing Costs Per use fees
  • 78. MammOptics Business Model Canvas 7 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance KOLs FDA Conferences 3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPs manufacturers Publishing Distributors Results Breast Cancer Foundations Patients: ACOG Radiation Free IP Non-Invasive Direct Sales to ACS hospitals Leading doctors Clinical trial designer Distributor Technical Expertise Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  • 79. MammOptics Business Model Canvas 8 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance KOLs FDA Conferences 3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPs manufacturers Publishing (local) Results Breast Cancer Foundations Patients: ACOG Radiation Free IP Non-Invasive Direct Sales to ACS hospitals Leading doctors Clinical trial designer Distributor Technical Expertise Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  • 80. MammOptics Business Model Canvas 9 Product Strong clinical Development Doctors: data IP Earlier detection Training Clinical trials Price Maintenance KOLs FDA Conferences 3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPs manufacturers Publishing (local) Results Breast Cancer Foundations Patients: ACOG Radiation Free IP Non-Invasive Direct Sales to ACS hospitals Leading doctors Clinical trial designer Distributor Technical Expertise Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  • 82. MammOptics Operations Stack Head Count 11 20 30 36 50 59 66
  • 83. MammOptics Financial Assumptions •  Gain  support  of  private  insurance   CPT  Code  Finalized   •  Greater  market  trac@on   Market  adop@on  rate   modeled  aKer    Cytyc’s   •  Similar  demographic,  procedure  count   ThinPrep   Steady  growth  of   •  Begin  at  2,500/device   procedure  count   •  4,000/device  average  mammograms   Priced  for  75%  gross   •  ThinPrep  78%  gross  margin   margin   •  Typical  in  medtech  industries  
  • 84. MammOptics Post-Launch Revenue Projection $250,000,000   $200,000,000   $150,000,000   7,300,000 procedures 4,000 devices $100,000,000   75% of revenue comes from 3,300,000 procedures per-use model revenue 1,900 devices $50,000,000   800,000 procedures 800 devices $0    2018      2019      2020   Forecasted  Revenue   Forecasted  COGS   Proxy  (Cytyc)  Revenue  AKer  Support  from  Insurance  
  • 85. MammOptics Proxy Margins Comparison MammOp@cs     Cytyc,  Year  2000   Steady  State   Steady  State   Revenue     $75.6M     $142.1M   Cost  of   $18.9M     $24.6M   Revenue     Gross  Margin     75%     83%   Engineering     $5.3M  (13%)     $14.2M  (10%)   Sales  and   $26.5M  (35%)     $55.2M  (39%)   Marke7ng     G  &  A   $3.0M  (7%)     $13.9M  (10%)   Net  Margin     19%     24%