I-Corps @ NIH

1. Team 21
Bio-Hybrid
Vascular Graft
Lessons Learned
October 10th 2014
104 TOTAL INTERVIEWS

2. Unmet Need:
Small diameter (<6mm) vascular grafts that are
ready-to-use and do not clot.
Value:
A clinical solution for patients where
harvesting autologous graft is not an option.
Unique Design:
Biodegradable polymer with proprietary
human analog coating (HuBiogel) to generate
new blood vessels.
4 mm
BIO-HYBRID VASCULAR GRAFT
Vascular Grafts for
Regeneration of Blood
Vessels
MVP

3. BIO-HYBRID VASCULAR GRAFT
Project Team
Steve Ceulemans,
MS, MBA
Industry Expert
 Birmingham
Business Alliance
 Biotech start-up
experience
 Industry analyst
Raj Singh,
Ph.D.
CEO
 Vivo Biosciences
Inc.
 VC-backed biotech
company
 Regenerative
biology expert
Yogesh Vohra
Ph.D.
PI
 University of
Alabama at
Birmingham
 Director, Center for
Nanoscale Materials
and Biointegration
 Biomaterials expert

4. BIO-HYBRID VASCULAR GRAFT
Initial Canvas
KEY
PARTNERS
UAB University
Center for
Nanoscale
materials and
Biointegration
(electrospinning
biodegradable
scaffold)
Vivo Bioscience
HuBiogel
proprietary
human analog
coating
KEY
ACTIVITIES
STTR Phase I
KEY
RESOURCE
S
IP / know-how
UAB
electrospinning,
analytical , and
animal facilities
Vivo HuBiogel
VALUE
PROPOSITIO
N
Ready-to-use (no
vascular
harvesting)
Low
thrombogenicity
Small diameter
possible (<6mm)
CUSTOMER
RELATIONSHIP
Medical Scientific
Liaison (MSL)
Health outcomes /
Cost effectiveness
Formulary /
reimbursement
CHANNELS
Sales reps
Distributors
CUSTOMER
SEGMENTS
Cardiothoracic
surgeons
Vascular
surgeons
Patients
Payors
(insurance)
Providers
(hospitals)
REVENUE
Grants Sales
COST STRUCTURE
R&D Overhead
Better cardiac bypass
grafts
VALUE PROPOSITION
Ready-to-use (no vascular
harvesting)
Low thrombogenicity
Small diameter possible
(<6mm)
CUSTOMER
SEGMENTS
Cardiothoracic surgeons
Vascular surgeons
Patients
Payors (insurance)
Providers (hospitals)

5. BIO-HYBRID VASCULAR GRAFT
We got out of the building
and met with our first customers...
and learned…
 We are in the vascular interventional
devices market
Coronary and peripheral technologies including
balloons, stents, grafts, IVC filters, IVUS &
angiography catheters, plaque modification devices,
hemodynamic flow alteration devices, and accessory
devices.
 Our Served Available Market:
Vascular grafts <6mm
Coronary Artery Disease - CAD Grafts
Peripheral Artery Disease - PAD Grafts
Hemodialysis (AV Grafts)
$10.5B
$800M (estim.)

6. BIO-HYBRID VASCULAR GRAFT
An interesting application popped up
Pediatric congenital
heart disease grafts
 1,000-2,000 cases/year.
 Typically initial corrective surgery with
synthetic graft followed by permanent
intervention later in life.
POSSIBLE OPPORTUNITY:
 FDA offers special support for pediatric technologies.
 There is a special FDA Humanitarian Device Exemption
(HDE) for technologies serving less than 2,000
patients/year.
 Only need to show safety, not efficacy

7. BIO-HYBRID VASCULAR GRAFT
Revised Canvas 1
KEY
PARTNERS
University
(UAB)
Target market:
Material
suppliers
4 possible segments
GMP
Manufacturing
Coronary artery disease grafts
Pediatric congenital disease grafts
Peripheral artery disease grafts
CRO
Hemodialysis (AV) grafts
Regulatory /
Reimbursement
Legal
KEY
ACTIVITIES
Preclinical
validation
Animal Data
Human Data
KEY
RESOURCE
S
IP
Biopolymer
HuBiogel
Electrospinning
VALUE
PROPOSITIO
N
3x Less
thrombogenic
Minimal
immunogenic
Surgery ready
Smaller diameter
possible (<6mm)
Dynamic
(grows with
patient)
CUSTOMER
RELATIONSHIP
Medical Scientific
Liaison
Cost effectiveness
Formulary /
reimbursement
CHANNELS
Sales reps
Distributors
CUSTOMER
SEGMENTS
Cardiothoracic
surgeons
(Vascular)
surgeons
Pediatric
surgeons
Patients
Payors
(insurance)
Providers
(hospitals)
REVENUE
Coronary Artery Disease – CAD grafts
Peripheral Artery Disease – PAD grafts
Hemodialysis grafts
COST STRUCTURE
R&D IP
Preclinical & Human
clinical development capital
KEY
PARTNERS
UAB University
Center for
Nanoscale
materials and
Biointegration
(electrospinning
biodegradable
scaffold)
Vivo Bioscience
HuBiogel
proprietary
human analog
coating
VALUE PROPOSITION
3x Less thrombogenic
Minimal immunogenic
Surgery ready
Smaller diameter possible
(<6mm)
Dynamic
(grows with patient)
CUSTOMER SEGMENTS
Cardiothoracic surgeons
(Vascular) surgeons
Pediatric surgeons
Patients
Payors (insurance)
Providers (hospitals
REVENUE
Coronary Artery Disease – CAD grafts
Peripheral Artery Disease – PAD grafts
Hemodialysis grafts

8. BIO-HYBRID VASCULAR GRAFT
Customer discovery: Customer segments
“A vascular surgeon is never the first doctor you see, the clinical
team/process can heavily influence the care you receive”
USER INFLUENCER DECISION MAKER ECONOMIC BUYER
Possible Saboteurs
Patient
Primary Care
ER Physician
Internist
Cardiologist
Nephrologist
Interventional
Cardiologist/
radiologist
Vascular
surgeon
Cardiothoracic
surgeon
P&T Committee
Bundled
Payment

9. BIO-HYBRID VASCULAR GRAFT
Revised Canvas 2
VALUE
KEY
PARTNERS
Strategic
marketing
partner
University
(UAB)
Material
suppliers
GMP
CRO
Investors
KEY
ACTIVITIES
PROPOSITION
Preclinical
validation
Animal Data
Human Data
Coronary grafts with
longer life than saponous
vein grafts (>5Y)
AV Graft / Fistula with
more than 50%
maturation rate
Limb ischemia graft with
better patency rates than
stents
Dynamic pediatric grafts
that only need single
surgery
KEY
RESOURCE
S
IP
Grants/contracts
Equip. supplies
Consultants
VALUE
PROPOSITIO
N
Coronary grafts
with longer life
than saponous vein
grafts (>5Y)
AV Graft / Fistula
with more than
50% maturation
rate
Limb ischemia graft
with better patency
rates than stents
Dynamic pediatric
grafts that only
need single surgery
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific
Liaison
CHANNELS
Sales reps
Strategic
marketing
partnership
Distributors
CUSTOMER
SEGMENTS
Cardio + vasc.
surgeons
Pediatric
surgeons
Hemodialysis
doctors
Interventional
cardiologist
radiologist
Patients
Payors
(insurance)
Providers
(hospitals)
KEY
PARTNERS
UAB University
Center for
Nanoscale
materials and
Biointegration
(electrospinning
biodegradable
scaffold)
COST STRUCTURE
R&D IP
Preclinical & Human
clinical development capital
REVENUE
Coronary Artery Disease – CAD grafts
Peripheral Artery Disease – PAD grafts
Hemodialysis grafts
New influencers and
decision makers:
Cardiologist
Hemodialysis doctors
Interventional cardiologist/radiologist
Vivo Bioscience
HuBiogel
proprietary
human analog
coating
CUSTOMER
SEGMENTS
Cardio + vasc.
surgeons
Pediatric surgeons
Hemodialysis
doctors
Interventional
cardiologist
radiologist
Patients
Payors (insurance)
Providers (hospitals)
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific
Liaison

10. BIO-HYBRID VASCULAR GRAFT
Regulatory
Pre-Clinical Clinical
“The only way to get human
data for an innovative device
like this in the U.S. is to bring
human data”
“Controlled polymer
degradation and regeneration
is a tough test to design”
Precedents in
Poland and Hungary
Most recent:
40 patients, 3 sites

11. BIO-HYBRID VASCULAR GRAFT
Revised Canvas 3
KEY
PARTNERS
Strategic
marketing
partner
University
(UAB)
GMP Compliant
CMO
Investors
Clinical Opinion
leaders/
champions
Strategic
marketing
partner
KEY
ACTIVITIES
Discovery Research
& Precl. validation
Animal Data
CE followed by
FDA
GLP / GMP
KEY
RESOURCE
S
IP
Grants/contracts
Equip. supplies
Consultants
VALUE
PROPOSITIO
N
Coronary grafts
with longer life
than saponous vein
grafts (>5Y)
AV Graft / Fistula
with more than
50% maturation
rate
Limb ischemia graft
with better patency
rates than stents
Dynamic pediatric
grafts that only
need single surgery
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific
Liaison
KEY
PARTNERS
UAB University
Center for
Nanoscale
materials and
Biointegration
(electrospinning
biodegradable
scaffold)
Talked to EU regulatory
experts and Updated
canvas
CHANNELS
Preclinical milestone: pig carotid data
Strategic
marketing
partnership
Distributors
CUSTOMER
SEGMENTS
Cardio + vasc.
surgeons
Pediatric
surgeons
Hemodialysis
doctors
Interventional
cardiologist
radiologist
Patients
Payors
(insurance)
Providers
(hospitals)
COST STRUCTURE
R&D & Preclin. Dev. IP
clinical development Consultants
Material & Equip. Human capital
Vivo Bioscience
HuBiogel
proprietary
human analog
coating
CE mark in EU (Poland) first
Clinical milestones:
restenosis
Peak walking test
REVENUE
Strategic marketing partnership royalties
Revenue from pilot programs / trials
Sales revenue from distributors
KEY PARTNERS
Strategic marketing partner
University (UAB)
GMP Compliant CMO
Investors
Clinical Opinion leaders/
champions
Strategic marketing partner
KEY ACTIVITIES
Discovery Research & Precl.
validation
Animal Data
CE followed by FDA
GLP / GMP
COST STRUCTURE
R&D & Preclin. Dev. IP
clinical development Consultants
Material & Equip. Human capital

12. BIO-HYBRID VASCULAR GRAFT
Prioritizing Target Markets
MON TUE WED
“There’s this great vascular
intervention conference
you should consider”
We learned a lot more about our market:
CORONARY ARTERY
DISEASE
PERIPHERAL ARTERY
DISEASE
HEMODIALYSIS
Innovation

13. BIO-HYBRID VASCULAR GRAFT
Customer Feedback: Prioritizing Applications
“Coronary bypass is the
absolute worst clinical
application to pursue, the
procedure is complicated and
if anything goes wrong there
are no easy fixes”
“Peripheral artery disease has
seen some recent innovations
and commercial successes, so
this market is hot; and there is
still an unmet need within a
market looking to evolve”
“There are no precedent
commercial successes using
the HDE/pediatric pathway,
combined with neonatal
intervention advances, this
will be a very difficult path”
“There will be an expectation
of equal performance to
synthetic AV grafts, which
can be used 3 weeks after
placement”

14. BIO-HYBRID VASCULAR GRAFT
Final Canvas
KEY
PARTNERS
Strategic
marketing
partner
University
(UAB)
GMP Compliant
CMO
Investors
Clinical Opinion
leaders/
champions
KEY
ACTIVITIES
Research & Precl.
validation
Animal Data
CE before FDA
GLP / GMP
Strategic partners
Re-prioritized markets
1. PAD
2. Hemodialysis
3. CAD
4. Congenital Heart disease
KEY
RESOURCE
S
IP
Grants/contracts
Equip. / supplies
Know-how
Consultants
VALUE
PROPOSITIO
N
Ready-to-use,
small diameter
(<6mm) vascular
graft where there
is currently no
alternative.
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Health outcomes /
cost effectiveness
CHANNELS
Strategic
marketing
partnership
Distributors
CUSTOMER
SEGMENTS
Vascular
surgeons
Referring
physicians
Hospital P&T
Committee
Payors
(insurance)
Patients
COST STRUCTURE
R&D & Preclin. Dev. IP
clinical development Consultants
Material & Equip. Human capital
REVENUE
Strategic marketing partnership royalties
Revenue from pilot programs / trials
Sales revenue from distributors

15. BIO-HYBRID VASCULAR GRAFT
Summary
and next steps
Pivot: CAD to PAD Grafts
Customers: Referring physicians are key influencers
Regulatory: Pre-clinical pig data; clinical CE mark in EU
followed by FDA
Reimbursement: ~$1,000
Next Step: Apply for STTR Phase II Spring 2015 with
nominal pivot.

16. BIO-HYBRID VASCULAR GRAFT
Medical Device
Investment Readiness
Level
Plausible exit
Cash to exit
Unit economics Validated
Reimbursement
Regulatory
Intellectual Property
Attractive solution & ID of MVP
Compelling clinical need + large market
Effective team?
Ended IRL 4.5
Started IRL 2

17. Video
https://www.youtube.com/w
atch?v=9bokuAtBJgg

18. Canvas
Progress

19. BIO-HYBRID VASCULAR GRAFT
Initial Canvas
KEY
PARTNERS
UAB University
Center for
Nanoscale
materials and
Biointegration
(electrospinning
biodegradable
scaffold)
Vivo Bioscience
HuBiogel
proprietary
human analog
coating
KEY
ACTIVITIES
STTR Phase I
KEY
RESOURCE
S
IP / know-how
UAB
electrospinning,
analytical , and
animal facilities
Vivo HuBiogel
VALUE
PROPOSITIO
N
Ready-to-use (no
vascular
harvesting)
Low
thrombogenicity
Small diameter
possible (<6mm)
CUSTOMER
RELATIONSHIP
Medical Scientific
Liaison (MSL)
Health outcomes /
Cost effectiveness
Formulary /
reimbursement
CHANNELS
Sales reps
Distributors
CUSTOMER
SEGMENTS
Cardiothoracic
surgeons
Vascular
surgeons
Patients
Payors
(insurance)
Providers
(hospitals)
REVENUE
Grants Sales
COST STRUCTURE
R&D Overhead
Better cardiac bypass
grafts

20. BIO-HYBRID VASCULAR GRAFT
Revised Canvas 1
KEY
PARTNERS
University
(UAB)
Target market:
Material
suppliers
4 possible segments
GMP
Manufacturing
Coronary artery disease grafts
Pediatric congenital disease grafts
Peripheral artery disease grafts
CRO
Hemodialysis (AV) grafts
Regulatory /
Reimbursement
Legal
KEY
ACTIVITIES
Preclinical
validation
Animal Data
Human Data
KEY
RESOURCE
S
IP
Biopolymer
HuBiogel
Electrospinning
VALUE
PROPOSITIO
N
3x Less
thrombogenic
Minimal
immunogenic
Surgery ready
Smaller diameter
possible (<6mm)
Dynamic
(grows with
patient)
CUSTOMER
RELATIONSHIP
Medical Scientific
Liaison
Cost effectiveness
Formulary /
reimbursement
CHANNELS
Sales reps
Distributors
CUSTOMER
SEGMENTS
Cardiothoracic
surgeons
(Vascular)
surgeons
Pediatric
surgeons
Patients
Payors
(insurance)
Providers
(hospitals)
REVENUE
Coronary Artery Disease – CAD grafts
Peripheral Artery Disease – PAD grafts
Hemodialysis grafts
COST STRUCTURE
R&D IP
Preclinical & Human
clinical development capital

21. BIO-HYBRID VASCULAR GRAFT
Revised Canvas 2
KEY
PARTNERS
Strategic
marketing
partner
University
(UAB)
Material
suppliers
GMP
CRO
Investors
KEY
ACTIVITIES
Preclinical
validation
Animal Data
Human Data
KEY
RESOURCE
S
IP
Grants/contracts
Equip. supplies
Consultants
VALUE
PROPOSITIO
N
Coronary grafts
with longer life
than saponous vein
grafts (>5Y)
AV Graft / Fistula
with more than
50% maturation
rate
Limb ischemia graft
with better patency
rates than stents
Dynamic pediatric
grafts that only
need single surgery
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific
Liaison
CHANNELS
Sales reps
Strategic
marketing
partnership
Distributors
CUSTOMER
SEGMENTS
Cardio + vasc.
surgeons
Pediatric
surgeons
Hemodialysis
doctors
Interventional
cardiologist
radiologist
Patients
Payors
(insurance)
Providers
(hospitals)
COST STRUCTURE
R&D IP
Preclinical & Human
clinical development capital
REVENUE
Coronary Artery Disease – CAD grafts
Peripheral Artery Disease – PAD grafts
Hemodialysis grafts
New influencers and
decision makers:
Cardiologist
Hemodialysis doctors
Interventional cardiologist/radiologist

22. BIO-HYBRID VASCULAR GRAFT
Revised Canvas 3
KEY
PARTNERS
Strategic
marketing
partner
University
(UAB)
GMP Compliant
CMO
Investors
Clinical Opinion
leaders/
champions
Strategic
marketing
partner
KEY
ACTIVITIES
Discovery Research
& Precl. validation
Animal Data
CE followed by
FDA
GLP / GMP
KEY
RESOURCE
S
IP
Grants/contracts
Equip. supplies
Consultants
VALUE
PROPOSITIO
N
Coronary grafts
with longer life
than saponous vein
grafts (>5Y)
AV Graft / Fistula
with more than
50% maturation
rate
Limb ischemia graft
with better patency
rates than stents
Dynamic pediatric
grafts that only
need single surgery
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific
Liaison
Talked to EU regulatory
experts and Updated
canvas
CHANNELS
Preclinical milestone: pig carotid data
Strategic
marketing
partnership
Distributors
CUSTOMER
SEGMENTS
Cardio + vasc.
surgeons
Pediatric
surgeons
Hemodialysis
doctors
Interventional
cardiologist
radiologist
Patients
Payors
(insurance)
Providers
(hospitals)
COST STRUCTURE
R&D & Preclin. Dev. IP
clinical development Consultants
Material & Equip. Human capital
CE mark in EU (Poland) first
Clinical milestones:
restenosis
Peak walking test
REVENUE
Strategic marketing partnership royalties
Revenue from pilot programs / trials
Sales revenue from distributors

23. BIO-HYBRID VASCULAR GRAFT
Final Canvas
KEY
PARTNERS
Strategic
marketing
partner
University
(UAB)
GMP Compliant
CMO
Investors
Clinical Opinion
leaders/
champions
KEY
ACTIVITIES
Research & Precl.
validation
Animal Data
CE before FDA
GLP / GMP
Strategic partners
Re-prioritized markets
1. PAD
2. Hemodialysis
3. CAD
4. Congenital Heart disease
KEY
RESOURCE
S
IP
Grants/contracts
Equip. / supplies
Know-how
Consultants
VALUE
PROPOSITIO
N
Ready-to-use,
small diameter
(<6mm) vascular
graft where there
is currently no
alternative.
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Health outcomes /
cost effectiveness
CHANNELS
Strategic
marketing
partnership
Distributors
CUSTOMER
SEGMENTS
Vascular
surgeons
Referring
physicians
Hospital P&T
Committee
Payors
(insurance)
Patients
COST STRUCTURE
R&D & Preclin. Dev. IP
clinical development Consultants
Material & Equip. Human capital
REVENUE
Strategic marketing partnership royalties
Revenue from pilot programs / trials
Sales revenue from distributors

24. Backup
Slides

25. Bio-Hybrid Vascular Graft
Unmet Need: Clot-Free Biocompatible Vascular
Grafts for Regeneration of Blood Vessels
Value: A clinical solution for patients where
autologous graft is not an available option
Unique Design: Natural biomatrix for
endothelium (HuBiogel) with biodegradable
scaffold for regrowth of vascular tissue
Prototype:

26. MVP
4 mm

27. Market
• Total Available Market:
– Global vascular interventional devices
market
– Coronary and peripheral endovascular
procedures including balloons, stents,
grafts, IVC filters, IVUS & angiography
catheters, plaque modification devices,
hemodynamic flow alteration devices
and accessory devices
• Served Available Market:
– Coronary Artery Disease - CAD Grafts
– Peripheral Artery Disease - PAD Grafts
– Pediatric Grafts
• Target Market:
– CAD, PAD, and pediatric grafts < 6mm

28. Business Model Canvas

29. Value Proposition Canvas
- Restore blood flow
- Create vascular
access
- Avoid readmissions
- Get higher QALY’s
- improve fistula
maturation
rate
- Range of diameter
(<6mm)
- No clotting
- Biocompatible,
Reproducible
- surgery-ready solutions
- Revision surgeries
- Complications
- Thrombosis / stenosis
- Infections
- 3x less clotting
- Minimally
immunogenic
- pre-coated, surgery
ready
- Unique biogel
promotes
endothelialization
- Grows w patient
-
- Reduced thrombosis results in
lower occlusion, infection, and
graft failure.
- Less revision surgeries
- Pre-coated, surgery-ready
- Pediatric grafts
- Femoral artery
graft
- AV fistula graft

30. Critical Activities
• Freedom to operate/IP?
– Possible freedom to operate issue on the utility of combining a
polymer with a biological matrix for a vascular graft. Evaluation
underway.
• Clinical Trials/regulatory?
– Likely combinatorial product composed of biological and
device.
– Likely BLA pathway will be dominant, meaning larger trial than
510k but smaller than PMA
– Possible FDA support and HDE exemption tied to pediatric
congenital heart disease with <4,500 cases/year.
• Quality information
– Since HuBiogel is a human-derived biological material, there
will be some stringent FDA quality testing requirements (e.g.
viral clearance).
– FDA has little experience with setting quality testing standards
for BLA products, but biosimilars might create precedent.

31. Critical Resources
Resources Associated
Activity
Cost Status
Research funding Preclin, validation NIH STTR
IP Preclin, animal,
human data
Provisional utility
patent filed
Equipment and
supplies:
polymers and
electrospinning
GMP / GLP
Hubiogel Scale-up and
manufacture
Commercial
grade
development
underway
CRO Develop strategic
partners
Define endpoints

32. Partners
Partners Resource / Activity Why Status $
University IP, equipment,
grants
Hold IP NIH STTR Phase I
Provisional patent
↔
GMP Hubiogel GLP/GMP
scale-up & manuf.
FDA
regulatory
risk
Material sourcing
& sale for research →
Regulatory:
CRO & FDA
Pediatric office
Clinical endpoints &
data
Pediatric
incentives
Identified
St.Jude’s, FDA
contact
→
Investors Clinical milestones,
manufacturing
Cross valley
of death
FDA vs CE
decision
←
Clinical
opinion leaders
Strategic partners
Define endpoints
Clinical
adoption
Engaged 18
clinicians
(→)
Materials
Solutions
Regulatory and
develop marketing
partner
Regulatory
starts with
material
Extensive dialog
with Evonik ↔
Marketing
Partner
Scale up and sales Sales &
distribution
Identified most
likely partners
←

33. Activities and resources
Preclinical
Studies
tissue
procurement
/ processing
CRO
Advocacy,
Clin.
Partner
Strategic
Marketing
Partner
Preclinica
l Studies
GLP /
GMP Mf
Animal
Data
Human
Data
Marketin
g
Activities
Resources / partners
UAB / S.
Research
Baxter SKIRBALL
CRF, AHA
St.Jude’s
Shire
Pharma
Possible partners

34. Channels
• Distribution:
– Strategic marketing partnership
• Abbott
• Cook
• Covidien (Medtronic)
– Alternatives
• Independent Distributors
• Direct sales through hospital pilot programs derived
from clinical trial champions
– Channel partner interest
• Key inflection point: human data
• Several recent companies acquired at human clinical
data stage

35. Channel Diagram
Preclinica
l Studies
GLP /
GMP Mf
Animal
Data
Strategic Marketing partner
license
Human
Data
Marketin
g
X% royalty
Champions from
clinical trials
Targeted
hospital
population
management
(pilot)
Direct
sales

36. Customer Workflow
Technology
committee?
Vascular surgeon
Nephrologist,
Internist,
Neonatologist,
Cardiologist.
Provider
Graft companies
Payor

37. Payment
• Bundled Payments
1. Coronary Artery Bypass Grafting: $39,572
2. Peripheral vascular disease graft: $5,812
• Graft Payments
- Arterial: $1,000-$2,000

38. Procedure Code Reimbursement

39. Payment flows
ER physician Physician services
cardiologist,
Interventional
cardiologist/radiologist
Internal
medicine/primary care
inpatient
$2,660 Anesthesia
Graft companies
Payor
(CMS)
Hospital svcs
outpatient
Diagnostics
Alternative /
complement
procedures
$3,845
$33,067
CABG $39,572
PVD $5,812
<$89 – $1,000

40. Finance timeline
Humacyte reference
Background:
- RTP, technology licensed from Duke & MIT.
- Tissue-based vascular grafts and regenerative medicine products
2009
$7M
2010
$12M
2012
$10M
2014
$37.25M
February 2011
Data published
in Science
Transitional
Medicine
December 2012
multi-center,
first-in-human
pilot study
starts in Poland
April 2013
Three-month
CE safety
review
complete
FDA IND
approval for
ESRD
October 2013
Strategic
Manufacturing
partnership
Allosource
June - July 2014
Clinial trial
enrollment
complete:
- 40 patients
EU
- 20 patients US
(3 sites each)
FDA Fast Track
approval