Mammoptics E245 Final Presentation

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Mammoptics E245 Final Presentation

  1. MammOpticsFinal project presentation for E 245 Winter 2011
  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 hypothesesCanvas #1: Finding the right customer Testing value proposition Purchasing decision treeCanvas #2: Getting to the customer Medical marketing Medical salesCanvas #3: Building the company Clinical trials Reimbursement Financing the company Company timelineReflection on the company Reflection on the medtech industry Key industry requirements Lessons learnedAppendix Financial calculations Business model canvas weeks 1-10
  4. Project OverviewInitial 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 TrainingHospitals Clinical trials MaintenanceLeading doctors Pioneering FDA Radiation-free3rd party radiologists in Earlier detectionmanufacturers hospitals Non-invasiveDistributors 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 TrainingHospitals Clinical trials MaintenanceLeading doctors Pioneering FDA Radiation-free3rd party radiologists in Earlier detectionmanufacturers Test: Non-invasive hospitals er segmentDistributors 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 dataHospitals (Capital IP Price TrainingSpending Clinical trials Accuracy Maintenance PioneeringCommittee) FDA DoctorsLeading doctors Patients: Hospitals3rd party Radiation Free OB/GYNsmanufacturers Non-Invasive PCPsDistributors Direct Sales to IPResearch 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 dataHospitals (Capital IP Price TrainingSpending Clinical trials Accuracy Maintenance PioneeringCommittee) FDA DoctorsLeading doctors Patients: Hospitals ur customer?3rd party Radiation Free OB/GYNs do we get to o Direct Salescitymanufacturers Non-Invasive PCPs How y and specifi toDistributorsResearch 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 customerThe 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 MarketingStrong 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 expensiveCommodity 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 deviceService per $3,000 $10,000 0 0 yearPer-use fee 0 0 $50 0Consumable 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 deviceService per $3,000 $10,000 0 0 yearPer-use fee 0 0 $50 0Consumable 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 MaintenanceLeading doctors FDA ConferencesKey Opinion Leaders Accuracy OB/GYNs Publishing CME courses PCPs3rd partymanufacturers Patients:Distributors Radiation FreeBreast Cancer Non-InvasiveFoundations Direct Sales to IPACOG hospitals Leading doctorsACS 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 MaintenanceLeading doctors FDA ConferencesKey Opinion Leaders Accuracy OB/GYNs Reimbursement CME courses PCPs3rd party Publishingmanufacturers Patients: e customerDistributors Radiation Free h ow to reach tBreast Cancer Non-Invasive Learned h Direct Sales d on seto this? a company baFoundations IP do we buildACOG hospitals Leading doctorsACS How Distributor Technical Expertise Product Development Clinical trials Capital Equipment Sales and Operating Costs disposable item Marketing Costs Per use fees
  41. Building the companyThe 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 PartnersManufacturing 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 PartnersManufacturing Reimbursement Difficult to get coverage for new product.
  47. MammOptics Reimbursement Partners Insurances CPT Codes $75-$150
  48. MammOptics PartnersManufacturing 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 PartnersManufacturing 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 timelineMilestones Beta Prototype Second Release Concept Product Design Beta- 1st Laboratory 2nd Release Test Version Release Prototype Testing Test Publication PublicationMilestones Clinical Pilot Clinical Post-Market Clinical US Interim Trials US Pivotal Clinical Results Studies Studies Trials Non-Specific Codes ProvisionalRegulatory/ 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 ClinicalProvisional Regulatory/ IP Patent MilestonesTechnology 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 ofMilestones Concept Beta Prototype Design Laboratory Beta- Version Prototype TestingMilestones Clinical Pilot Studies ProvisionalRegulatory/ 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 MarketableMilestones Beta Prototype Product Design Laboratory Beta- Version Prototype TestingMilestones Clinical Pilot StudiesRegulatory/ 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 / ClinicalMilestones Second Release Design 1st Release Test PublicationMilestones Clinical Pilot US Interim Trials US Pivotal Clinical Studies TrialsRegulatory/ 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 LaunchMilestones Second Release Design 2nd Release Test Publication PublicationMilestones Clinical Clinical US Interim Trials US Pivotal Clinical Results Trials Non-Specific CodesRegulatory/ 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 LaunchMilestones Design PublicationMilestones Clinical Clinical Post-Market Clinical Results Studies Non-Specific CodesRegulatory/ 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 MarketableMilestones Beta Prototype Second Release Concept Product Design Beta- 1st Laboratory 2nd Release Test Version Release Prototype Testing Test Publication PublicationMilestones Clinical Pilot Clinical Post-Market Clinical US Interim Trials US Pivotal Clinical Results Studies Studies Trials Non-Specific Codes ProvisionalRegulatory/ 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 MaintenanceKOLs FDA Conferences3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPsmanufacturers PublishingDistributors ResultsBreast CancerFoundations Patients:ACOG Radiation Free IP Non-Invasive Direct Sales toACS hospitals Leading doctorsClinical 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 MaintenanceKOLs FDA Conferences3rd party Earlier detection OB/GYNs Reimbursement Non invasive CME courses PCPsmanufacturers PublishingBreast Cancer Price iness modelFoundations Accuracy ion of our busACOG Immediate Results Final iterat Direct Sales to ic tu b ig p re… nk about theACS IP i … need to thClinical 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 CompanyLessons 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 tooperateIntellectual Creates entry barrierProperty for competitors
  71. Near 50 interviews Around 50 hrs/weekSpecial 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 TrainingHospitals Clinical trials Radiation-free Maintenance PioneeringLeading doctors FDA Earlier detection Doctors3rd party Non invasive HospitalsmanufacturersDistributors 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 PioneeringHospitals FDA Earlier detection DoctorsLeading doctors Non invasive Hospitals3rd partymanufacturersDistributorsResearch 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 dataHospitals (Capital IP Price TrainingSpending Clinical trials Accuracy Maintenance PioneeringCommittee) FDA DoctorsLeading doctors Patients: Hospitals3rd party Radiation Freemanufacturers Non-InvasiveDistributors Direct Sales to IPResearch 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 dataHospitals (Capital IP Price TrainingSpending Clinical trials Accuracy Maintenance PioneeringCommittee) FDA Immediate DoctorsLeading doctors Results Hospitals3rd party OB/GYNsmanufacturers Patients: PCPsDistributors Radiation Free IP Non-Invasive Direct Sales toResearch Hospitals hospitals Leading doctorsBreast Cancer Technical ExpertiseFoundations 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 MaintenanceLeading doctors FDA ConferencesKey Opinion Leaders Accuracy OB/GYNs Reimbursement CME courses PCPs3rd party Publishingmanufacturers Patients:Distributors Radiation FreeBreast Cancer Non-InvasiveFoundations Direct Sales to IPACOG hospitals Leading doctorsACS 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 MaintenanceKOLs FDA Conferences3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPsmanufacturers PublishingDistributors ResultsBreast CancerFoundations Patients:ACOG Radiation Free IP Non-Invasive Direct Sales toACS 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 MaintenanceKOLs FDA Conferences3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPsmanufacturers PublishingDistributors ResultsBreast CancerFoundations Patients:ACOG Radiation Free IP Non-Invasive Direct Sales toACS hospitals Leading doctorsClinical 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 MaintenanceKOLs FDA Conferences3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPsmanufacturers Publishing(local) ResultsBreast CancerFoundations Patients:ACOG Radiation Free IP Non-Invasive Direct Sales toACS hospitals Leading doctorsClinical 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 MaintenanceKOLs FDA Conferences3rd party Accuracy OB/GYNs Reimbursement Immediate CME courses PCPsmanufacturers Publishing(local) ResultsBreast CancerFoundations Patients:ACOG Radiation Free IP Non-Invasive Direct Sales toACS hospitals Leading doctorsClinical trial designer Distributor Technical Expertise Product Development Clinical trials Per use fees Operating Costs Marketing Costs
  81. MammOptics Operations StackHead Count 11 20 30 36 50 59 66
  82. 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  
  83. 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  
  84. 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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