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Rvex Engr245 2021 Lessons Learned
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
250,000 people in the United States are waiting
for heart transplants, but fewer than 5000 of
them will receive a donor heart.
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
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.
Right Heart Failure (RHF) occurs
in 30-40% of LVAD implantations
Extremely unpredictable
High mortality and morbidity
burden
Inefficient, Invasive, High risk
therapies
We created a novel technology, now what?
RVEX MVP
Benchtop set-up
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?
Is the LVAD market big enough for this product to be
financially viable as a venture?
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
Efficacy in LVAD
patient
population
Size of LVAD-
adjunct markets
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
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
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.
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
“
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
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
“
Critical Pivot: RVEX as a platform technology
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
5000 500,000
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
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
Funding: RVEX secures non-dilutive funding from Coulter
Foundation!!!
Medical Device Translational Grant
Supports collection of pre-clinical data
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
R&D: RVEX preclinical safety studies in small animals
demonstrate fast, safe implantation
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
Partnerships: Additive manufacturing leader to support
product development
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
MedTech Activities: key learnings from regulatory and
reimbursement
Regulatory
Class III device (PMA pathway)
Our technology qualifies for
FDA Breakthrough designation
Outlined clinical endpoints and
effect size
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
Reimbursement
Qualified for existing DRG codes
Breakthrough designation
provides 4 years of automatic
CMS coverage
The Future: Incubate Technology at Stanford
W1 W2 W3 W5
W4 W6 W7 W8 W10
W9
Potential new partners / funding
sources
Existing partners / funding
sources
Research & Development
Appendix
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
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
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.

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Rvex Engr245 2021 Lessons Learned

  • 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? W1 W2 W3 W5 W4 W6 W7 W8 W10 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 W1 W2 W3 W5 W4 W6 W7 W8 W10 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. W1 W2 W3 W5 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 W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 “
  • 13. Critical Pivot: RVEX as a platform technology W1 W2 W3 W5 W4 W6 W7 W8 W10 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 W1 W2 W3 W5 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 W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
  • 16. R&D: RVEX preclinical safety studies in small animals demonstrate fast, safe implantation W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
  • 17. Partnerships: Additive manufacturing leader to support product development W1 W2 W3 W5 W4 W6 W7 W8 W10 W9
  • 18. MedTech Activities: key learnings from regulatory and reimbursement Regulatory Class III device (PMA pathway) Our technology qualifies for FDA Breakthrough designation Outlined clinical endpoints and effect size W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 Reimbursement Qualified for existing DRG codes Breakthrough designation provides 4 years of automatic CMS coverage
  • 19. The Future: Incubate Technology at Stanford W1 W2 W3 W5 W4 W6 W7 W8 W10 W9 Potential new partners / funding sources Existing partners / funding sources Research & Development
  • 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.