BioHybrid Graft I-Corps@NIH 121014
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Transcript of BioHybrid Graft I-Corps@NIH 121014
Team 21
Bio-Hybrid Vascular GraftLessons LearnedOctober 10th 2014
104 TOTAL INTERVIEWS
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
BIO-HYBRID VASCULAR GRAFT
Project Team
Steve Ceulemans,
MS, MBAIndustry 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
BIO-HYBRID VASCULAR GRAFT
Initial Canvas
KEY
PARTNERS
UAB University Center for Nanoscale materials and Biointegration(electrospinningbiodegradable scaffold)
Vivo Bioscience HuBiogelproprietary human analog coating
KEY
ACTIVITIES
STTR Phase I
KEY
RESOURCE
S
IP / know-howUAB 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)
REVENUEGrants Sales
COST STRUCTURER&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)
and learned… We are in the vascular interventional
devices marketCoronary 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 <6mmCoronary Artery Disease - CAD Grafts
Peripheral Artery Disease - PAD GraftsHemodialysis (AV Grafts)
BIO-HYBRID VASCULAR GRAFT
We got out of the buildingand met with our first customers...
$800M (estim.)
$10.5B
1,000-2,000 cases/year.
Typically initial corrective surgery with synthetic graft followed by permanent intervention later in life.
BIO-HYBRID VASCULAR GRAFT
An interesting application popped up
Pediatric congenital heart disease grafts
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
BIO-HYBRID VASCULAR GRAFT
Revised Canvas 1
KEY
PARTNERS
University (UAB)
Material suppliers
GMP Manufacturing
CRO
Regulatory / Reimbursement
Legal
KEY
ACTIVITIES
Preclinical validation
Animal Data
Human Data
KEY
RESOURCES
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)
REVENUECoronary Artery Disease – CAD graftsPeripheral Artery Disease – PAD graftsHemodialysis grafts
COST STRUCTURER&D IPPreclinical & Humanclinical development capital
Target market: 4 possible segments
Coronary artery disease graftsPediatric congenital disease grafts
Peripheral artery disease graftsHemodialysis (AV) grafts
KEY
PARTNERS
UAB University Center for Nanoscale materials and Biointegration(electrospinningbiodegradable scaffold)
Vivo Bioscience HuBiogelproprietary 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
REVENUECoronary Artery Disease – CAD grafts
Peripheral Artery Disease – PAD grafts
Hemodialysis grafts
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 CommitteeBundled Payment
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
RESOURCES
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 pediatricgrafts 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
Interventionalcardiologist radiologist
Patients
Payors(insurance)
Providers (hospitals)
COST STRUCTURER&D IPPreclinical & Humanclinical development capital
REVENUECoronary Artery Disease – CAD graftsPeripheral Artery Disease – PAD graftsHemodialysis grafts
New influencers and decision makers:
CardiologistHemodialysis doctors
Interventional cardiologist/radiologist
KEY
PARTNERS
UAB University Center for Nanoscale materials and Biointegration(electrospinningbiodegradable scaffold)
Vivo Bioscience HuBiogelproprietary human analog coating
VALUE
PROPOSITION
Coronary grafts with longer life than saponousvein 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
SEGMENTS
Cardio + vasc. surgeons
Pediatric surgeons
Hemodialysis doctors
Interventionalcardiologist radiologist
Patients
Payors (insurance)
Providers (hospitals)
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific Liaison
BIO-HYBRID VASCULAR GRAFT
Regulatory
“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”
Pre-Clinical Clinical
Precedents in
Poland and HungaryMost recent:
40 patients, 3 sites
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
RESOURCES
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 pediatricgrafts that only need single surgery
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific Liaison
CHANNELS
Strategic marketing partnership
Distributors
CUSTOMER
SEGMENTS
Cardio + vasc. surgeons
Pediatric surgeons
Hemodialysis doctors
Interventionalcardiologist radiologist
Patients
Payors(insurance)
Providers (hospitals)
COST STRUCTURER&D & Preclin. Dev. IPclinical development ConsultantsMaterial & Equip. Human capital
REVENUEStrategic marketing partnership royaltiesRevenue from pilot programs / trialsSales revenue from distributors
Talked to EU regulatory experts and Updated
canvas
Preclinical milestone: pig carotid dataCE mark in EU (Poland) first
Clinical milestones:restenosis
Peak walking test
KEY
PARTNERS
UAB University Center for Nanoscale materials and Biointegration(electrospinningbiodegradable scaffold)
Vivo Bioscience HuBiogelproprietary human analog coating
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 ConsultantsMaterial & Equip. Human capital
BIO-HYBRID VASCULAR GRAFT
Prioritizing Target Markets
MON TUE WED
We learned a lot more about our market:
CORONARY ARTERY
DISEASE
PERIPHERAL ARTERY
DISEASEHEMODIALYSIS
Innovation
“There’s this great vascular intervention conference you should consider”
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”
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
KEY
RESOURCES
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 STRUCTURER&D & Preclin. Dev. IPclinical development ConsultantsMaterial & Equip. Human capital
REVENUEStrategic marketing partnership royaltiesRevenue from pilot programs / trialsSales revenue from distributors
Re-prioritized markets
1. PAD2. Hemodialysis3. CAD4. Congenital Heart disease
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.
BIO-HYBRID VASCULAR GRAFT
Summary
and next steps
BIO-HYBRID VASCULAR GRAFT
Medical Device
Investment Readiness
Level
Reimbursement
Effective team?
Attractive solution & ID of MVP
Unit economics Validated
Cash to exit
Plausible exit
Compelling clinical need + large market
Intellectual Property
Regulatory
Started IRL 2
Ended IRL 4.5
Canvas
Progress
BIO-HYBRID VASCULAR GRAFT
Initial Canvas
KEY
PARTNERS
UAB University Center for Nanoscale materials and Biointegration(electrospinningbiodegradable scaffold)
Vivo Bioscience HuBiogelproprietary human analog coating
KEY
ACTIVITIES
STTR Phase I
KEY
RESOURCE
S
IP / know-howUAB 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)
REVENUEGrants Sales
COST STRUCTURER&D Overhead
Better cardiac bypass grafts
BIO-HYBRID VASCULAR GRAFT
Revised Canvas 1
KEY
PARTNERS
University (UAB)
Material suppliers
GMP Manufacturing
CRO
Regulatory / Reimbursement
Legal
KEY
ACTIVITIES
Preclinical validation
Animal Data
Human Data
KEY
RESOURCES
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)
REVENUECoronary Artery Disease – CAD graftsPeripheral Artery Disease – PAD graftsHemodialysis grafts
COST STRUCTURER&D IPPreclinical & Humanclinical development capital
Target market: 4 possible segments
Coronary artery disease graftsPediatric congenital disease grafts
Peripheral artery disease graftsHemodialysis (AV) grafts
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
RESOURCES
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 pediatricgrafts 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
Interventionalcardiologist radiologist
Patients
Payors(insurance)
Providers (hospitals)
COST STRUCTURER&D IPPreclinical & Humanclinical development capital
REVENUECoronary Artery Disease – CAD graftsPeripheral Artery Disease – PAD graftsHemodialysis grafts
New influencers and decision makers:
CardiologistHemodialysis doctors
Interventional cardiologist/radiologist
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
RESOURCES
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 pediatricgrafts that only need single surgery
CUSTOMER
RELATIONSHIP
Clin. opinion leader
Pub. Agreements
Patient advocacy
Medical Scientific Liaison
CHANNELS
Strategic marketing partnership
Distributors
CUSTOMER
SEGMENTS
Cardio + vasc. surgeons
Pediatric surgeons
Hemodialysis doctors
Interventionalcardiologist radiologist
Patients
Payors(insurance)
Providers (hospitals)
COST STRUCTURER&D & Preclin. Dev. IPclinical development ConsultantsMaterial & Equip. Human capital
REVENUEStrategic marketing partnership royaltiesRevenue from pilot programs / trialsSales revenue from distributors
Talked to EU regulatory experts and Updated
canvas
Preclinical milestone: pig carotid dataCE mark in EU (Poland) first
Clinical milestones:restenosis
Peak walking test
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
KEY
RESOURCES
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 STRUCTURER&D & Preclin. Dev. IPclinical development ConsultantsMaterial & Equip. Human capital
REVENUEStrategic marketing partnership royaltiesRevenue from pilot programs / trialsSales revenue from distributors
Re-prioritized markets
1. PAD2. Hemodialysis3. CAD4. Congenital Heart disease
Backup
Slides
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:
MVP
4 mm
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
Business Model Canvas
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 biogelpromotes
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
• 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.
Critical Activities
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 partnersDefine endpoints
Partners
Partners Resource / Activity Why Status $
University IP, equipment, grants
Hold IP NIH STTR Phase IProvisional 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
IdentifiedSt.Jude’s, FDA contact
→
Investors Clinical milestones,manufacturing
Cross valley of death
FDA vs CE decision
←
Clinical opinion leaders
Strategic partnersDefine 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
←
Preclinical Studies
tissue procurement/ processing
CROAdvocacy,
Clin. Partner
Strategic Marketing
Partner
Activities and resources
Preclinical Studies
GLP / GMP Mf
Animal Data
Human Data
Marketing
Activities
Resources / partners
UAB / S. Research
Baxter SKIRBALLCRF, AHA
St.Jude’sShire
Pharma
Possible partners
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
Channel Diagram
Preclinical Studies
GLP / GMP Mf
Animal Data
Human Data
Marketing
Strategic Marketing partner license
X% royalty
Champions from clinical trials
Targeted hospital
population management
(pilot)
Direct sales
Customer Workflow
Vascular surgeon
Nephrologist,Internist,
Neonatologist,Cardiologist.
Provider
Graft companies
Payor
Technology committee?
Payment
• Bundled Payments
1. Coronary Artery Bypass Grafting: $39,572
2. Peripheral vascular disease graft: $5,812
• Graft Payments
- Arterial: $1,000-$2,000
Procedure Code Reimbursement
Payment flows
Physician servicesER physiciancardiologist,
Interventional cardiologist/radiologist
Internal medicine/primary care
inpatient
Graft companies
Payor(CMS)
Hospital svcs
outpatient
DiagnosticsAlternative / complement procedures
CABG $39,572PVD $5,812
$3,845
$33,067
Anesthesia$2,660
<$89 – $1,000
Finance timeline
2009
$7M
2010 $12M
2012 $10M
2014 $37.25M
Humacyte referenceBackground: - RTP, technology licensed from Duke & MIT.- Tissue-based vascular grafts and regenerative medicine products
Feb
ruar
y 2
011 Data published
in Science Transitional Medicine
Dec
emb
er 2
012 multi-center,
first-in-human pilot study starts in Poland A
pri
l 20
13 Three-month CE safety review complete
FDA IND approval for ESRD
Oct
ob
er 2
013 Strategic
ManufacturingpartnershipAllosource
Jun
e-
July
2014
Clinial trial enrollment complete:- 40 patients EU - 20 patients US (3 sites each)
FDA Fast Trackapproval