Post on 20-Aug-2015
MammOptics Final project presentation for E 245 Winter 2011
MammOptics The Team
Pedro Hernandez Emma Medjuck
Josef Miler Ramin Miri
BS Chemical Eng., Stanford U. MS Chemical Eng. (candidate) Mayfield Fellow 2010
BS Mechanical Eng, MIT MS Mechanical Eng., Stanford U. PhD Mechanical Eng. (candidate)
BComm Business/Math, McGill U. MS MS&E (candidate)
BS Electrical Eng., Sharif U. MS Electrical Eng., Stanford U. MS MS&E, Stanford U. PhD, Electrical Eng. (candidate)
Brings experience of internship at Pacific Biosciences. Numerous courses in entrepreneurship.
Technical consulting for start-ups. Expert witness in medtech IP case. Background in IP.
PhD research in optical spectroscopy signal processing. Numerous courses in entrepreneurship.
Previous experience with customer discovery and customer activities.
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 Leading cause of cancer in women 190,000 diagnosis every year US 41,000 deaths every year US Increasing diagnosis rates
Mammography
15%-25% false negatives rate 25% false positives rate Requires X-ray radiation Low resolution
Novel technology based on RF-modulated optical spectroscopy
MammOptics
- Earlier detection - Non-radiative - Non-invasive
MammOptics Technology Comparison
Risk Invasiveness Resolution False Pos.
False Neg.
Device Cost Time
Required
MammOptics Very Low Very Low <.1 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.
I.I.T.Y.I.W.H.T.K.Y
MammOptics Business Model Canvas 1 of 4
Radiation-free Earlier detection Non-invasive
Pioneering radiologists in hospitals
Direct sales to hospitals
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs Capital equipment sales
and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals Leading doctors 3rd party manufacturers Distributors
MammOptics Business Model Canvas 1 of 4
Radiation-free Earlier detection Non-invasive
Pioneering radiologists in hospitals
Direct sales to hospitals
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs Capital equipment sales
and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals Leading doctors 3rd party manufacturers Distributors
MammOptics Business Model Canvas 1 of 4
Test: Customer segment
Value proposition
Finding the right customer From radiologists to gynecologists
MammOptics Excursions into hospitals
Leading doctors
Patients
Hospital Managers
Technicians
Debra Ikeda Jason Davies
Jafi Alissa Lipson Sunita Pal
6 women >40 8 women <40
Alicia X-ray mammography
Paul Billings Holly V. Gautier
MammOptics Hospital purchasing decision tree
MammOptics Hospital purchasing decision tree
Hospitals Complex purchasing decision tree.
Several saboteours
MammOptics Private practice purchasing decision tree
MammOptics Private practice purchasing decision tree
Private practice
Faster adoption rate
Attractive value proposition ✔
Pioneering Doctors Hospitals OB/GYNs PCPs
Direct Sales to doctors
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs
Capital Equipment Sales and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals (Capital Spending Committee) Leading doctors 3rd party manufacturers Distributors Research Hospitals
Doctors: Earlier detection Price Accuracy
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 2 of 4
Pioneering Doctors Hospitals OB/GYNs PCPs
Direct Sales to doctors
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs
Capital Equipment Sales and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals (Capital Spending Committee) Leading doctors 3rd party manufacturers Distributors Research Hospitals
Doctors: Earlier detection Price Accuracy
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 2 of 4
How do we get to our customer?
Need sensitivity and specificity
Getting to our customer The world of direct sales and medical marketing
MammOptics Interviews
Breast Cancer Advocacy Groups
OB/GYNs
FDA/Clinical Trials
Medical Sales
Be Bright Pink Jennifer Glover
Dr. Cindy Woo Dr. Jags Powers
Dr. Aaron Shuvkan
Katrina Bell Tanay Dudhela
Jed Hwang
Phyllis Whitely Carl Simpson
Market Adoption
Key Opinion Leaders (KOLs)
Medical Journals
Continuing Medical Education
Conferences
Breast Cancer Advocacy Groups
American College of Obstetricians
and Gynecologists (ACOG)
MammOptics Marketing
Market Adoption
Key Opinion Leaders (KOLs)
Medical Journals
Continuing Medical Education
Conferences
American College of Obstetricians
and Gynecologists (ACOG)
American College of Obstetricians
and Gynecologists (ACOG)
Access to ACOG by former member
Strong influence on doctors via ACOG Standard of Care
Strongly influenced by KOLs
MammOptics Marketing
Market Adoption
Key Opinion Leaders (KOLs)
Medical Journals
Continuing Medical Education
Conferences
American College of Obstetricians
and Gynecologists (ACOG)
American College of Obstetricians
and Gynecologists (ACOG)
Researchers conducting important
clinical trials
Researchers with numerous
publications
Outsourced survey research
Researchers with strong peer
recommendations
MammOptics Marketing
Market Adoption
Key Opinion Leaders (KOLs)
Medical Journals
Continuing Medical Education
Conferences
American College of Obstetricians
and Gynecologists (ACOG)
American College of Obstetricians
and Gynecologists (ACOG)
Focus on prominent journals Need two big
publications
Choose KOL as Principal Investigators (PI)
MammOptics Marketing
Market Adoption
Key Opinion Leaders (KOLs)
Medical Journals
Continuing Medical Education
Conferences
American College of Obstetricians
and Gynecologists (ACOG)
American College of Obstetricians
and Gynecologists (ACOG)
Effective method for educating doctors
Doctors required to attend workshops
Workshop must be approved by ACOG
Taught by objective medical experts
MammOptics Marketing
Market Adoption
Key Opinion Leaders (KOLs)
Medical Journals
Continuing Medical Education
Conferences
American College of Obstetricians
and Gynecologists (ACOG)
American College of Obstetricians
and Gynecologists (ACOG)
ACOG Annual Clinical Meeting
Miami Breast Cancer Conference
Opportunity for feedback from
doctors
MammOptics Marketing
Market Adoption
Key Opinion Leaders (KOLs)
Medical Journals
Continuing Medical Education
Conferences
Breast Cancer Advocacy Groups
American College of Obstetricians
and Gynecologists (ACOG)
Trusted information source for patients
Critical opinion leader for technology adoption
Access to media outlets
MammOptics Marketing
Individual Doctors
Purchasing Administrators
High value medical products
(e.g. cardiovascular stents)
Commodity medical products
(e.g. latex gloves)
• Doctor education • Direct feedback from doctors • Very expensive
• No doctor education • No customer feedback • Inexpensive
Direct Sales
Distributors
MammOptics Channel Strategies and Costs
Individual Doctors
Purchasing Administrators
Channel Strategies and Costs MammOptics
5 dedicated sales people $150,000 each/year
Hire nurses or technicians with established relationships
Early adopter feedback
Continue with core group of sales people
Use women’s healthcare equipment distributor
Already established network of customers
Sales strategy 1 Sales strategy 2
MammOptics Pricing Strategy
Equipment Lease model Per-use model Consumable
Cost of the device
Service per year
Per-use fee
Consumable
$50,000
$3,000
0
0
$5,000
$10,000
0
0
$5,000
0
$50
0
$25,000
0
0
$20
MammOptics Pricing Strategy
Equipment Lease model Per-use model Consumable
Cost of the device
Service per year
Per-use fee
Consumable
$50,000
$3,000
0
0
$5,000
$10,000
0
0
$5,000
0
$50
0
$25,000
0
0
$20
Approved by customers
and investors
ACOG ACS
Doctor specialty committee
Hospital Administration
Technician
Radiologist Mammography
MammOptics Customer Workflow
Current market Insurance
ACOG ACS
Doctor specialty committee
Hospital Administration
Technician
Radiologist Mammography
MammOptics Customer Workflow
Current market
But what would happen if we replace mammography?
Insurance
ACOG ACS
Doctor specialty committee
Hospital Administration
Technician
Radiologist Mammography
MammOptics Customer Workflow
Breast Radiologists Technicians Hospitals
Loss of jobs Loss of jobs Eliminates loss leader
Puts emphasis on biopsies
Insurance
ACOG ACS
Doctor specialty committee
Hospital Administration
Technician
Radiologist Mammography
MammOptics Customer Workflow
Insurance
ACOG ACS
Doctor specialty committee
Hospital Administration
Technician
Radiologist Mammography
MammOptics Customer Workflow
Insurance Same cost as mammography ($140) Reduced number of biopsies ($1000)
ACOG/ACS Improved healthcare
(mammography weak technique)
Insurance
ACOG ACS
Doctor specialty committee
Hospital Administration
Technician
Insurance
Radiologist Mammography
MammOptics Customer Workflow
Insurance
Doctor specialty committee
Hospital Administration
Technician
Radiologist Mammography
MammOptics Customer Workflow
ACOG ACS
MammOptics
Patient PCP OB/GYN
Insurance
Doctor specialty committee
Hospital Administration
Technician
Radiologist Mammography
MammOptics Customer Workflow
ACOG ACS
MammOptics
Patient PCP OB/GYN
Hospital Administration
Technician
Radiologist Mammography
MammOptics
Patient PCP OB/GYN PCP OB/GYNs
Increased revenue More complete patient care
Patient Improved healthcare
Comfort
MammOptics Revenue
ACOG ACS
Doctor specialty committee
Hospital Administration
Technician
Insurance
Radiologist Mammography
MammOptics Customer Workflow
MammOptics
Patient PCP OB/GYN
OB/GYNs PCPs
Direct Sales to hospitals Distributor
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Capital Equipment Sales and disposable item Per use fees
Product Development IP Clinical trials FDA Publishing
IP Leading doctors Technical Expertise
Leading doctors Key Opinion Leaders 3rd party manufacturers Distributors Breast Cancer Foundations ACOG ACS
Doctors: Earlier detection Price Accuracy
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 3 of 4
OB/GYNs PCPs
Direct Sales to hospitals Distributor
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Capital Equipment Sales and disposable item Per use fees
Product Development IP Clinical trials FDA ReimbursementPublishing
IP Leading doctors Technical Expertise
Leading doctors Key Opinion Leaders 3rd party manufacturers Distributors Breast Cancer Foundations ACOG ACS
Doctors: Earlier detection Price Accuracy
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 3 of 4
Learned how to reach the customer
How do we build a company based on this?
Building the company The backstage of a medical device company
MammOptics Interviews
FDA Clinical Trials
Manufacturing
Venture Capitalists
Reimbursement
Stanford Statistics Steve Axelrod
Marga Ortigas-Wedekind
Nick Mourlas Don Archambault
Shannon Bergstedt Ali Habib
Dana Mead Bill Starling
Doctors/Sales Dr. Aron Shuftan Jed Hwang
Michael J. Nohr
Manufacturing
MammOptics Partners
Choose manufacturing facility close to
home
Manufacturing Partner
75% gross margin
9 Inches
~5 lbs
DSP
RFIC
Photo probe
Disposable head
Discounts for Revenue Model COGS
$4-5k per unit
MammOptics
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
Technology MammOptics
I.I.T.Y.I.W.H.T.K.Y
Manufacturing Reimbursement
MammOptics Partners
Difficult to get coverage for new
product.
Manufacturing
MammOptics Partners
Reimbursement Partners MammOptics
Insurances
CPT Codes $75-$150
MammOptics Partners
Manufacturing
FDA Clinical Trials
Reimbursement
510K vs. PMA Largest cost
Biggest financial risk
Clinical Trials
12/4/2009
Stage 1 Pilot trials
50 patients $600K
MammOptics
6 months
Feasibility Comparison with mammography
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1 Pilot trials
Stage 2 Interim trials
500 patients $7.2M
Prove superior safety-efficacy &
sensitivity
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1 Pilot trials
Stage 2 Interim trials
24 months
Stage 3 FDA pivotal
trials 1500 patients
$20.5M
FDA class II, 510(K) w/ trials
Focus on superiority & economic end-
points
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1 Pilot trials
Stage 2 Interim trials
Stage 3 FDA pivotal
trials
Stage 4 Post-market
studies 2000 patients
$26.8M
Specific Cat III CPT/ACP Codes
Market traction
24 months 24 months
Clinical Trials
12/4/2009
MammOptics
6 months 15 months
Stage 1 Pilot trials
Stage 2 Interim trials
Stage 3 FDA pivotal
trials $600K
$7.2M
$20.5M
$26.8M
Stage 4 Post-market
studies
24 months 24 months
Clinical Trials
12/4/2009
MammOptics
MammOptics Partners
MammOptics Partners
Manufacturing
FDA Clinical Trials
Reimbursement
Financial timeline
Funding
$10M
$15M
2012
Series A $3.5 MM
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Initialize
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
Launch
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
Series D $35 MM
M&A / IPO $50 MM $40M
56 12/4/2009
Proof of Concept
Pilot Studies
IC and Processing
Patents
Marketable Product
Provisional Patent
Beta-Version Testing
Application and System
Patents
IRB / IDE
Clinical Results
Second Release
Initial Product Launch
Specific Codes (Cat. I CPT / APC)
Non-Specific Codes
1st Release
Test
2nd Release Test
Publication
Post-Market Clinical Studies
Beta Prototype
US Interim Trials
FDA – Class II – 510 (k) with Clinical Trials
Publication
Financial / Operations Timeline
Cat III CPT
US Pivotal Clinical Trials
Laboratory Prototype
Technology Licensing
MammOptics MammOptics
Financial timeline
$10M
$15M
2012
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Initialize
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016 2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
$30M
$20M
$40M
57 12/4/2009
Proof of Concept
Provisional Patent
Financial / Operations Timeline
Technology Licensing
MammOptics MammOptics
$10M
$15M
2012
Series A $3.5 MM
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Initialize
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016 2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
$30M
$20M
$40M
58 12/4/2009
Proof of Concept
Provisional Patent
Beta-Version Testing
Laboratory Prototype
Beta Prototype
Technology Licensing
Financial / Operations Timeline
Pilot Studies
MammOptics MammOptics
$10M
$15M
2012
Series A $3.5 MM
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
$30M
$20M
$40M
59 12/4/2009
IC and Processing
Patents
Marketable Product
Beta-Version Testing
Application and System
Patents
IRB / IDE
Beta Prototype
Financial / Operations Timeline
Pilot Studies
Regulatory / Clinical
Laboratory Prototype
MammOptics MammOptics
$10M
$15M
2012
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
$40M
60
IC and Processing
Patents
Application and System
Patents
IRB / IDE
Cat III CPT
Second Release
1st Release
Test
US Interim Trials US Pivotal Clinical Trials
Publication
Financial / Operations Timeline
Pilot Studies
MammOptics MammOptics
$10M
$15M
2012
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016 2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
Launch
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
Series D $35 MM
$40M
61 12/4/2009
Clinical Results
Second Release
Initial Product Launch
Non-Specific Codes
2nd Release Test
Publication
US Interim Trials
FDA – Class II – 510 (k) with Clinical Trials
Publication
Financial / Operations Timeline
US Pivotal Clinical Trials
MammOptics MammOptics
$10M
$15M
2012
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016 2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
Launch
$30M
$20M
Regulatory / Clinical
Series D $35 MM
M&A / IPO $50 MM $40M
12/4/2009
Clinical Results
Initial Product Launch
Specific Codes (Cat. I CPT / APC)
Non-Specific Codes
Publication
Post-Market Clinical Studies
FDA – Class II – 510 (k) with Clinical Trials
Financial / Operations Timeline MammOptics MammOptics
$10M
$15M
2012
Series A $3.5 MM
Cash
Res
erve
Cl
inic
al
Mile
ston
es
$5M
Initialize
Des
ign
Mile
ston
es
Regu
lato
ry/ I
P M
ilest
ones
Q1 Q2 Q3 Q4
2013 Q1 Q2 Q3 Q4
2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015 2016
Series B $9 MM
2017 Q1 Q2 Q1 Q2 Q3 Q4
2018 Q3
Launch
Series C $30.5 MM
$30M
$20M
Regulatory / Clinical
Series D $35 MM
M&A / IPO $50 MM $40M
63 12/4/2009
Proof of Concept
Pilot Studies
IC and Processing
Patents
Marketable Product
Provisional Patent
Beta-Version Testing
Application and System
Patents
IRB / IDE
Clinical Results
Second Release
Initial Product Launch
Specific Codes (Cat. I CPT / APC)
Non-Specific Codes
1st Release
Test
2nd Release Test
Publication
Post-Market Clinical Studies
Beta Prototype
US Interim Trials
FDA – Class II – 510 (k) with Clinical Trials
Publication
Financial / Operations Timeline
Cat III CPT
US Pivotal Clinical Trials
Laboratory Prototype
Technology Licensing
MammOptics MammOptics
MammOptics Business Model Canvas 4 of 4
OB/GYNs PCPs
Direct Sales to hospitals Distributor Online
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Per use fees
Product Development IP Clinical trials FDA Reimbursement Publishing
IP Leading doctors Technical Expertise
KOLs 3rd party manufacturers Distributors Breast Cancer Foundations ACOG ACS Clinical trial designer
Doctors: Earlier detection Price Accuracy Immediate Results
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 4 of 4
Earlier detection Non invasive Price Accuracy Immediate Results
OB/GYNs PCPs
Direct Sales to hospitals Distributor Online
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Per use fees
Product Development IP Clinical trials FDA Reimbursement Publishing
IP Leading doctors Technical Expertise
KOLs 3rd party manufacturers Breast Cancer Foundations ACOG ACS Clinical trial designer
Final iteration of our business model
But… need to think about the big picture…
Reflection on the Company Lessons learned from the medical device industry
MammOptics Fundamental Challenges of a Medtech Startup
FDA approval
Medical technology
Reimbursement
Intellectual Property
MammOptics Fundamental Challenges of a Medtech Startup
FDA approval
Reimbursement Capital intensive
Long time to market
Dependence on KOLs
Profitability networks
Medical technology
Intellectual Property
MammOptics Fundamental Challenges of a Medtech Startup
FDA approval
Reimbursement Capital intensive
Long time to market
Dependence on KOLs
Profitability networks
Medical technology
Intellectual Property
Gives freedom to operate
Creates entry barrier for competitors
Intellectual Property
Thank you… Business Model Recap
Near 50 interviews Around 50 hrs/week
Special thanks to our mentors
Rowan Chapman Steve Turner
Jason Davies
Radiation-free Earlier detection Non invasive
Pioneering Doctors Hospitals
Direct Sales to hospitals
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs
Capital Equipment Sales and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals Leading doctors 3rd party manufacturers Distributors
MammOptics Business Model Canvas 1
Radiation-free Earlier detection Non invasive
Pioneering Doctors Hospitals
Direct Sales to hospitals
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs
Capital Equipment Sales and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals Leading doctors 3rd party manufacturers Distributors Research Hospitals
MammOptics Business Model Canvas 2
Pioneering Doctors Hospitals
Direct Sales to hospitals
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs
Capital Equipment Sales and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals (Capital Spending Committee) Leading doctors 3rd party manufacturers Distributors Research Hospitals
Doctors: Earlier detection Price Accuracy
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 3
Pioneering Doctors Hospitals OB/GYNs PCPs
Direct Sales to hospitals
Strong clinical data Training Maintenance
Product Development Clinical trials Operating Costs
Capital Equipment Sales and disposable item
Product Development IP Clinical trials FDA
IP Leading doctors Technical Expertise
Hospitals (Capital Spending Committee) Leading doctors 3rd party manufacturers Distributors Research Hospitals Breast Cancer Foundations
Doctors: Earlier detection Price Accuracy Immediate Results
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 4
OB/GYNs PCPs
Direct Sales to hospitals Distributor
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Capital Equipment Sales and disposable item
Product Development IP Clinical trials FDA ReimbursementPublishing
IP Leading doctors Technical Expertise
Leading doctors Key Opinion Leaders 3rd party manufacturers Distributors Breast Cancer Foundations ACOG ACS
Doctors: Earlier detection Price Accuracy
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 5
OB/GYNs PCPs
Direct Sales to hospitals Distributor
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Capital Equipment Sales and disposable item Per use fees
Product Development IP Clinical trials FDA Reimbursement Publishing
IP Leading doctors Technical Expertise
KOLs 3rd party manufacturers Distributors Breast Cancer Foundations ACOG ACS
Doctors: Earlier detection Price Accuracy Immediate Results
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 6
OB/GYNs PCPs
Direct Sales to hospitals Distributor
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Per use fees
Product Development IP Clinical trials FDA Reimbursement Publishing
IP Leading doctors Technical Expertise
KOLs 3rd party manufacturers Distributors Breast Cancer Foundations ACOG ACS Clinical trial designer
Doctors: Earlier detection Price Accuracy Immediate Results
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 7
OB/GYNs PCPs
Direct Sales to hospitals Distributor
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Per use fees
Product Development IP Clinical trials FDA Reimbursement Publishing
IP Leading doctors Technical Expertise
KOLs 3rd party manufacturers (local) Breast Cancer Foundations ACOG ACS Clinical trial designer
Doctors: Earlier detection Price Accuracy Immediate Results
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 8
OB/GYNs PCPs
Direct Sales to hospitals Distributor
Strong clinical data Training Maintenance Conferences CME courses
Product Development Clinical trials Operating Costs Marketing Costs
Per use fees
Product Development IP Clinical trials FDA Reimbursement Publishing
IP Leading doctors Technical Expertise
KOLs 3rd party manufacturers (local) Breast Cancer Foundations ACOG ACS Clinical trial designer
Doctors: Earlier detection Price Accuracy Immediate Results
Patients: Radiation Free Non-Invasive
MammOptics Business Model Canvas 9
MammOptics Operations Stack
Head Count 11 20 30 36 50 59 66
• Gain support of private insurance • Greater market trac@on
CPT Code Finalized
• Similar demographic, procedure count Market adop@on rate modeled aKer Cytyc’s
ThinPrep
• Begin at 2,500/device • 4,000/device average mammograms
Steady growth of procedure count
• ThinPrep 78% gross margin • Typical in medtech industries
Priced for 75% gross margin
MammOptics Financial Assumptions
$0
$50,000,000
$100,000,000
$150,000,000
$200,000,000
$250,000,000
Forecasted Revenue Forecasted COGS Proxy (Cytyc) Revenue AKer Support from Insurance
2018 2019 2020
800,000 procedures
3,300,000 procedures
7,300,000 procedures
800 devices
1,900 devices
4,000 devices
75% of revenue comes from per-use model revenue
MammOptics Post-Launch Revenue Projection
MammOp@cs Steady State
Cytyc, Year 2000 Steady State
Revenue $75.6M $142.1M
Cost of Revenue
$18.9M $24.6M
Gross Margin 75% 83% Engineering $5.3M (13%) $14.2M (10%) Sales and Marke7ng
$26.5M (35%) $55.2M (39%)
G & A $3.0M (7%) $13.9M (10%) Net Margin 19% 24%
MammOptics Proxy Margins Comparison