BioHybrid Graft I-Corps@NIH 121014
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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 ï§ Birmingham Business Alliance ï§ Biotech start-up experience ï§ Industry analyst Raj Singh, Ph.D. CEO ï§ Vivo Biosciences Inc. ï§ VC-backed biotech company ï§ Regenerative biology expert Yogesh Vohra Ph.D. PI ï§ University of Alabama at Birmingham ï§ Director, Center for Nanoscale Materials and Biointegration ï§ 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 learnedâŠ ïŒ 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. ïŒ 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 ïŒ 1,000-2,000 cases/year. ïŒ Typically initial corrective surgery with synthetic graft followed by permanent intervention later in life. POSSIBLE OPPORTUNITY: ï§ FDA offers special support for pediatric technologies. ï§ There is a special FDA Humanitarian Device Exemption (HDE) for technologies serving less than 2,000 patients/year. ï§ 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 â CAD grafts Peripheral Artery Disease â 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 â CAD grafts Peripheral Artery Disease â PAD grafts Hemodialysis grafts
- 8. BIO-HYBRID VASCULAR GRAFT Customer discovery: Customer segments âA vascular surgeon is never the first doctor you see, the clinical team/process can heavily influence the care you receiveâ 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 â CAD grafts Peripheral Artery Disease â 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 âThe only way to get human data for an innovative device like this in the U.S. is to bring human dataâ âControlled polymer degradation and regeneration is a tough test to designâ 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 âThereâs this great vascular intervention conference you should considerâ 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 âCoronary bypass is the absolute worst clinical application to pursue, the procedure is complicated and if anything goes wrong there are no easy fixesâ âPeripheral 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 evolveâ âThere are no precedent commercial successes using the HDE/pediatric pathway, combined with neonatal intervention advances, this will be a very difficult pathâ âThere will be an expectation of equal performance to synthetic AV grafts, which can be used 3 weeks after placementâ
- 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
- 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 â CAD grafts Peripheral Artery Disease â 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 â CAD grafts Peripheral Artery Disease â 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 âą Total Available Market: â Global vascular interventional devices market â Coronary and peripheral endovascular procedures including balloons, stents, grafts, IVC filters, IVUS & angiography catheters, plaque modification devices, hemodynamic flow alteration devices and accessory devices âą Served Available Market: â Coronary Artery Disease - CAD Grafts â Peripheral Artery Disease - PAD Grafts â Pediatric Grafts âą Target Market: â CAD, PAD, and pediatric grafts < 6mm
- 29. Value Proposition Canvas - Restore blood flow - Create vascular access - Avoid readmissions - Get higher QALYâs - 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 âą Freedom to operate/IP? â Possible freedom to operate issue on the utility of combining a polymer with a biological matrix for a vascular graft. Evaluation underway. âą Clinical Trials/regulatory? â Likely combinatorial product composed of biological and device. â Likely BLA pathway will be dominant, meaning larger trial than 510k but smaller than PMA â Possible FDA support and HDE exemption tied to pediatric congenital heart disease with <4,500 cases/year. âą Quality information â Since HuBiogel is a human-derived biological material, there will be some stringent FDA quality testing requirements (e.g. viral clearance). â 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 â GMP Hubiogel GLP/GMP scale-up & manuf. FDA regulatory risk Material sourcing & sale for research â Regulatory: CRO & FDA Pediatric office Clinical endpoints & data Pediatric incentives Identified St.Judeâs, FDA contact â Investors Clinical milestones, manufacturing Cross valley of death FDA vs CE decision â Clinical opinion leaders Strategic partners Define endpoints Clinical adoption Engaged 18 clinicians (â) Materials Solutions Regulatory and develop marketing partner Regulatory starts with material Extensive dialog with Evonik â Marketing Partner Scale up and sales Sales & distribution Identified most likely partners â
- 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.Judeâs Shire Pharma Possible partners
- 34. Channels âą Distribution: â Strategic marketing partnership âą Abbott âą Cook âą Covidien (Medtronic) â Alternatives âą Independent Distributors âą Direct sales through hospital pilot programs derived from clinical trial champions â Channel partner interest âą Key inflection point: human data âą 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 âą Bundled Payments 1. Coronary Artery Bypass Grafting: $39,572 2. Peripheral vascular disease graft: $5,812 âą Graft Payments - Arterial: $1,000-$2,000
- 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 â $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
Hinweis der Redaktion
- Entire current canvas for completeness.
- Estimated cost of graft fabrication within same order of magnitude as current composite reimbursement level. All arterial vessle transplants are much more expensive, typically between $1,000 and $2,000 Leutonix precedent (first drug eluding balloon on US market): obtained CE mark and were acquired by Bard ï no early revenue generated.
- Graft reimbursement schedule from Gore Autologous material typically reimbursed at $1,000 Composite typically reimbursed at $83