business model, business model canvas, mission model, mission model canvas, customer development, lean launchpad, lean startup, stanford, startup, steve blank, entrepreneurship, I-Corps, Stanford
2. Ileana Pirozzi (L)
DESIGNER/HACKER
Max Denning (L)
PICKER
Ali Kight (L)
HACKER/DESIGNER
Davide Zanchi (L)
HUSTLER
Andre Esteva
Mentor
RVEX
TEAM
WEEK 1 WEEK 10
82 interviews
Biomimetic Sleeve Platform Technology
3. 250,000 people in the United States are waiting
for heart transplants, but fewer than 5000 of
them will receive a donor heart.
4. 250,000 people in the United States are waiting
for heart transplants, but fewer than 5000 of
them will receive a donor heart.
Left Ventricular Assist Devices (LVADs) could change their lives...
… with the help of RVEX
5. The Left Ventricular Assist
Device (LVAD) is an
artificial pump implanted in
the left ventricle to replace
or support the function of a
failing heart.
6. Right Heart Failure (RHF) occurs
in 30-40% of LVAD implantations
Extremely unpredictable
High mortality and morbidity
burden
Inefficient, Invasive, High risk
therapies
7. We created a novel technology, now what?
RVEX MVP
Benchtop set-up
8. BUSINESS MODEL CANVAS
Key customers
Manufacturers
Physicians
Providers
Payors
Preclinical/
Clinical Trials
Regulatory
Manufacturing
Quality control
Training
Value:
Minimize
incidence of RHF
post LVAD
implantation
Promote
increased
utilization of
LVADs to
support the 250k
waiting patients
Decrease cost
for stakeholders
by obviating
need for
reoperations
MedTech
Abbott
Medtronic
Edwards
Thoratec
Surgeons
Product Research & Development
($100k) Manufacturing Costs ($100/unit)
Price: Effect size * QALYs ($150k/QALY)
~ $5,000 per unit
Direct Sales
Hospitals
IP
Expertise
Testing
Facilities
Manufacturing
FDA/Regulatory
4
B2B: Clinical
development,
licensing,
regulatory
5
6
7
8
9
B2B: Device
manufacturers
B2C:
Clinicians
3
Manufacturing
Carbon 3D
FluidForm 3D
B2C: Training,
sales
Beneficiaries
Primary
beneficiary is the
patient. Extended
beneficiary are
the families and
caregivers
Licensing/M&A
MedTech Giant
Organizations
key partners key activities
cost structures
key resources
value proposition
1
customer relationships customer segments
channels
revenue streams
2
Value/Clinical
Strategy:
Promote
increased
utilization of
LVADs to
support the
250k waiting
patients
Activities:
What are our
regulatory,
reimbursement,
strategies?
9. Is the LVAD market big enough for this product to be
financially viable as a venture?
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W9
Efficacy in LVAD
patient
population
Size of LVAD-
adjunct markets
10. Initial Hypothesis: our technology, alongside existing
trends, will enable expansion of the LVAD market
Reduce adverse
events
Increase adoption
Expand market
RVEX as LVAD -
Adjunct
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W9
11. Critical Insight: LVAD adoption and market are not
guaranteed to expand with technological innovation
The limiting reagent for LVAD utilization is the
cardiologist - they are not referring patients
because there is a lack of education around
the technology.
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W4 W6 W7 W8 W10
W9
“
12. Pivotal Insight: Our technology can be useful beyond LVADs
Why focus solely on LVADs? You have a
technology that can help and doesn’t hurt -
it can be adopted and used as a “safety
net” to help the right ventricle after many
other procedures
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W9
“
13. Critical Pivot: RVEX as a platform technology
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W9
5000 500,000
14. Updated Clinical Strategy: Going after Right Heart Failure,
one beat at a time
Phase 1: “Foot in the door”
Right-Heart Failure Device
Strategy: LVAD-adjunct
❏ Smaller patient population
❏ Severely ill patients
2021 - 2023 2022 - 2027
Phase 2: Product Expansion
Right-Heart Failure Device
Strategy: Procedure-adjunct
❏ Larger patient population
❏ Moderately ill patients
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W4 W6 W7 W8 W10
W9
15. Funding: RVEX secures non-dilutive funding from Coulter
Foundation!!!
Medical Device Translational Grant
Supports collection of pre-clinical data
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W4 W6 W7 W8 W10
W9
21. FDA
Key customers
Hospitals
Surgeons (VAD)
Medical device
companies
Experimental data
Reimbursement
Regulatory / FDA
Manufacturing
Quality control
IP Strategy
Education
Value:
Reduce
complications
post cardiac
surgery
“Foot in the door”
LVAD - adjunct
Value:
MedTech
Abbott
Medtronic
Product Research & Development
($100k) Manufacturing Costs ($100/unit)
Price: Effect size * QALYs ($150k/QALY)
~ $20,000 per unit
Reimbursement calculations
Direct Sales
Hospitals
Indirect Sales
Distributors
IP
Expertise
Testing
Facilities
Manufacturing
MedTech
Incubators
Stanford OTL
5
6
7
8
9
B2B: Device
manufacturers
B2C:
Clinicians
3
BUSINESS MODEL CANVAS
Manufacturin
g
Carbon 3D
FluidForm 3D
Surgeons
Beneficiaries
Primary
beneficiary is the
patient. Extended
beneficiary are
the families and
caregivers
Licensing/M&A
MedTech Giant
Organizations
key partners key activities
cost structures
key resources
value proposition
1
customer relationships customer segments
channels
revenue streams
2
Advocates
Surgeons
Cardiologists
4
Regulatory
FDA/EMA
Regulatory
consultants
Insurance
companies
22. Fundraising & Clinical Development
Plan
Q1 Q2 Q3 Q4
2021 2022 2023 2024
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Cash
reserves
5M
10
M
20M
30
M Seed
$5M
Series A
$15M
Clinical
Milestones
Design
Milestones
Pre-submission
meetings FDA
$20 000
Proof of
Concept
Benchtop
Testing
Analyze
Results
Partnerships
with
manufacturer
s
Regulatory/
IP
Milestones
IDE Submission
and Approval
$150 000
Clinical Phase Ia
(First-in-Humans, Pilot
1)
$4M
Clinical Phase Ib
(Pilot 2)
$10M
Pre-Clinical Phase I & II
$100,000
Iterative
Design
Refinemen
t
Device
Refinement
Human - ready device
Pre-Seed
(Non-dilutive)
$300,000
Device Refinement
$150 000
2025
Q1 Q2 Q3 Q4
Series B
$60M
Device
Refinement
Breakthrough
Designation
$50 000
CMS 4-
year
coverage
Provisional IP
filed
Issued IP
PMA Submission
and Approval
$300 000
Clinical Phase II
(Pivotal)
$48M
Pre-submission meetings FDA
$100 000
23. What’s our story? (Brainstorm slide)
1. From academia to patients is a black box
2. LLP → Black box uncovered
3. Initial hypothesis → LVAD Market will expand with technological innovation (trends analysis)
a. Thus, LVAD market remains limited / doesn’t justify company formation
4. From device to platform
a. Technological basis, KOL, clinical due diligence
b. Input from KOLs, financial analysis
c. Will address indications in the future
d. First focus on a narrow population
5. Overview of regulatory / reimbursement / health economics learnings
a. PMA w Breakthrough, DRG codes, CMS reimbursement, collect data for future adjustments to
reimbursement, IP strategy (broad, encompassing of various indications, etc)
6. Next steps
a. LVAD is still foot-in-the-door
i. Inflection point is clinical data
1. Best way to get good clinical data is to pick the right initial population (enrichment
strategy) - identify population you’re most likely to have good outcomes for
a. Gated approach. If fails → fails quickly and saves money
b. Benefit from being incubated in University environment until efficacy data in large animals
i. Advice from incubators, investors, etc.