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Team 21 
Bio-Hybrid 
Vascular Graft 
Lessons Learned 
October 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 fo...
BIO-HYBRID VASCULAR GRAFT 
Project Team 
Steve Ceulemans, 
MS, MBA 
Industry Expert 
 Birmingham 
Business Alliance 
 Bi...
BIO-HYBRID VASCULAR GRAFT 
Initial Canvas 
KEY 
PARTNERS 
UAB University 
Center for 
Nanoscale 
materials and 
Biointegra...
BIO-HYBRID VASCULAR GRAFT 
We got out of the building 
and met with our first customers... 
and learned… 
 We are in the ...
BIO-HYBRID VASCULAR GRAFT 
An interesting application popped up 
Pediatric congenital 
heart disease grafts 
 1,000-2,000...
BIO-HYBRID VASCULAR GRAFT 
Revised Canvas 1 
KEY 
PARTNERS 
University 
(UAB) 
Target market: 
Material 
suppliers 
4 poss...
BIO-HYBRID VASCULAR GRAFT 
Customer discovery: Customer segments 
“A vascular surgeon is never the first doctor you see, t...
BIO-HYBRID VASCULAR GRAFT 
Revised Canvas 2 
VALUE 
KEY 
PARTNERS 
Strategic 
marketing 
partner 
University 
(UAB) 
Mater...
BIO-HYBRID VASCULAR GRAFT 
Regulatory 
Pre-Clinical Clinical 
“The only way to get human 
data for an innovative device 
l...
BIO-HYBRID VASCULAR GRAFT 
Revised Canvas 3 
KEY 
PARTNERS 
Strategic 
marketing 
partner 
University 
(UAB) 
GMP Complian...
BIO-HYBRID VASCULAR GRAFT 
Prioritizing Target Markets 
MON TUE WED 
“There’s this great vascular 
intervention conference...
BIO-HYBRID VASCULAR GRAFT 
Customer Feedback: Prioritizing Applications 
“Coronary bypass is the 
absolute worst clinical ...
BIO-HYBRID VASCULAR GRAFT 
Final Canvas 
KEY 
PARTNERS 
Strategic 
marketing 
partner 
University 
(UAB) 
GMP Compliant 
C...
BIO-HYBRID VASCULAR GRAFT 
Summary 
and next steps 
Pivot: CAD to PAD Grafts 
Customers: Referring physicians are key infl...
BIO-HYBRID VASCULAR GRAFT 
Medical Device 
Investment Readiness 
Level 
Plausible exit 
Cash to exit 
Unit economics Valid...
Video 
https://www.youtube.com/w 
atch?v=9bokuAtBJgg
Canvas 
Progress
BIO-HYBRID VASCULAR GRAFT 
Initial Canvas 
KEY 
PARTNERS 
UAB University 
Center for 
Nanoscale 
materials and 
Biointegra...
BIO-HYBRID VASCULAR GRAFT 
Revised Canvas 1 
KEY 
PARTNERS 
University 
(UAB) 
Target market: 
Material 
suppliers 
4 poss...
BIO-HYBRID VASCULAR GRAFT 
Revised Canvas 2 
KEY 
PARTNERS 
Strategic 
marketing 
partner 
University 
(UAB) 
Material 
su...
BIO-HYBRID VASCULAR GRAFT 
Revised Canvas 3 
KEY 
PARTNERS 
Strategic 
marketing 
partner 
University 
(UAB) 
GMP Complian...
BIO-HYBRID VASCULAR GRAFT 
Final Canvas 
KEY 
PARTNERS 
Strategic 
marketing 
partner 
University 
(UAB) 
GMP Compliant 
C...
Backup 
Slides
Bio-Hybrid Vascular Graft 
Unmet Need: Clot-Free Biocompatible Vascular 
Grafts for Regeneration of Blood Vessels 
Value: ...
MVP 
4 mm
Market 
• Total Available Market: 
– Global vascular interventional devices 
market 
– Coronary and peripheral endovascula...
Business Model Canvas
Value Proposition Canvas 
- Restore blood flow 
- Create vascular 
access 
- Avoid readmissions 
- Get higher QALY’s 
- im...
Critical Activities 
• Freedom to operate/IP? 
– Possible freedom to operate issue on the utility of combining a 
polymer ...
Critical Resources 
Resources Associated 
Activity 
Cost Status 
Research funding Preclin, validation NIH STTR 
IP Preclin...
Partners 
Partners Resource / Activity Why Status $ 
University IP, equipment, 
grants 
Hold IP NIH STTR Phase I 
Provisio...
Activities and resources 
Preclinical 
Studies 
tissue 
procurement 
/ processing 
CRO 
Advocacy, 
Clin. 
Partner 
Strateg...
Channels 
• Distribution: 
– Strategic marketing partnership 
• Abbott 
• Cook 
• Covidien (Medtronic) 
– Alternatives 
• ...
Channel Diagram 
Preclinica 
l Studies 
GLP / 
GMP Mf 
Animal 
Data 
Strategic Marketing partner 
license 
Human 
Data 
Ma...
Customer Workflow 
Technology 
committee? 
Vascular surgeon 
Nephrologist, 
Internist, 
Neonatologist, 
Cardiologist. 
Pro...
Payment 
• Bundled Payments 
1. Coronary Artery Bypass Grafting: $39,572 
2. Peripheral vascular disease graft: $5,812 
• ...
Procedure Code Reimbursement
Payment flows 
ER physician Physician services 
cardiologist, 
Interventional 
cardiologist/radiologist 
Internal 
medicin...
Finance timeline 
Humacyte reference 
Background: 
- RTP, technology licensed from Duke & MIT. 
- Tissue-based vascular gr...
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BioHybrid Graft I-Corps@NIH 121014

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I-Corps @ NIH

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BioHybrid Graft I-Corps@NIH 121014

  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

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