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Affinity I-Corps@NIH 121014
Affinity Therapeutics is developing drug-coated vascular grafts and drug-eluting wraps to reduce stenosis rates and failure in hemodialysis patients. They interviewed 128 potential customers including nephrologists, surgeons, and patients, and identified two minimum viable products - a coated graft and a drug-eluting wrap that could be used with fistulas or grafts. Based on further interviews and analysis, they determined the wrap has potential for a larger market. Affinity plans to submit a Phase II SBIR grant to further develop the wrap MVP and continue cultivating relationships with key opinion leaders and medical centers.
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Affinity I-Corps@NIH 121014
- 1. Affinity Therapeutics Drugdelivery grafts for immediate vascular access and reduced failure rates in hemodialysis patients. Sean T. Zuckerman, Horst von Recum, Paul Olson 1 #05 Total Interviews: 128 Weekly Average: 13 PI C Level Industry Expert
- 2. What we thoughtinitially •~400,000 Hemodialysis pts in US •~80,000 pts with AV Graft •Target is ~50% of market 2 TAM = 400,000 pts SAM = 80,000 pts Target = 40,000 pts Source: US Renal Data Service, 2013 Annual Report
- 3. What we thoughtinitially •Affinity’s graft would be so good we could increase market share of grafts 3 TAM = 400,000 pts SAM = >>> 80,000 pts Target = >>> 40,000 pts Source: US Renal Data Service, 2013 Annual Report
- 4. Vascular Access •Longterm vascular access critical for hemodialysis •Arteriovenous (AV) grafts common but suboptimal option 4
- 5. Coated AV Graftfor Long Term Vascular Access 5 BLOOD Time BLOOD BLOOD Blood BLOOD Normal AV Graft lifespan BLOOD BLOOD Smooth muscle cells AV Graft Affinity’s coating Affinity’s Graft lifespan
- 6.
- 7. So we did… •Interviewed 128 customers starting with –Nephrologists –Vascular Surgeons –National Kidney Foundation & Kidney Disease Increasing Global Outcomes (KDIGO) 7
- 8. So we did… •Interviewed 128 potential customers –Nephrologists –Vascular Surgeons –National Kidney Foundation & Kidney Disease Increasing Global Outcomes (KDIGO) –Dialysis Clinics –More nephrologists –Patients 8
- 9. Initial Canvas 9 Medical Device Co’s Vascular Surgeons & Nephrologists Dialysis Pts Increase sales Decrease stenosis rates Ease pain & hassle Preclinical studies Large animal Proof of Concept studies CROs Value Analysis Committee IP Licensing Acquisition CROs SBIR grants Publish Medical Device Co’s
- 10. Initial Canvas 10 Medical Device Co’s Vascular Surgeons & Nephrologists Dialysis Pts Increase sales Decrease stenosis rates Ease pain & hassle Licensing Acquisition Publish
- 11. Week 2 Canvas 11 Decision Maker @ Medical Device Co’s Vascular Surgeons, Nephrologists, Interventionalists Dialysis Pts Increase sales Decrease stenosis rates 50% Ease pain & hassle Preclinical studies Large animal Proof of Concept studies CROs Value Analysis Committee IP Licensing Acquisition CROs SBIR grants Publish Medical Device Co’s Nat’l Kidney Foundation Center for Devices & Radiological Health
- 12. Customer Interviews PatientWorkflow 12 Neph- rologist PtVascular Surgeon PtVascular Access Implanted Pt PtDIALYSIS! PtInterventionalist •Nephrologist (loosely) owns the patient •Vascular surgeons typically choose access type •Sometimes interventionalistimplants
- 13. Piggy-Back our MVPon MarketedGore Triple-Layered AcuSeal™ •“Sandwich” coating between layers •Newer product = smaller market share 13
- 14. Week 6 Canvas 14 Decision Maker @ Medical Device Co’s Vascular Surgeons, Nephrologists, Interventionalists Dialysis Pts Increase sales Decrease stenosis rates 50% Ease pain & hassle Preclinical studies Large animal Proof of Concept studies CROs Value Analysis Committee IP Licensing Acquisition CROs SBIR grants Publish: JAMA, Circulation, J VascSurgery, Medical Device Co’s Nat’l Kidney Foundation Center for Devices & Radiological Health Admin Contractor @ CMS KOL Conference: Kidney Week Increase graft life 25%
- 15. Week 6 Canvas 15 Decision Maker @ Medical Device Co’s Vascular Surgeons, Nephrologists, Interventionalists Dialysis Pts Increase sales Decrease stenosis rates 50% Ease pain & hassle Preclinical studies Large animal Proof of Concept studies CROs Value Analysis Committee IP Licensing Acquisition CROs SBIR grants Publish: JAMA, Circulation, J VascSurgery, Medical Device Co’s Nat’l Kidney Foundation Center for Devices & Radiological Health Admin Contractor @ CMS KOL Conference: Kidney Week Increase graft life 25%
- 16. Revisited the GraftMarket •CPT Code: ~$1000 reimbursement •$40 million Target Market •PMA likely costs $10s of millions… 16 TAM = 400,000 pts SAM = $80 Million Target = $40 Million Source: US Renal Data Service, 2013 Annual Report
- 17. Revisited the GraftMarket •CPT Code: ~$1000 reimbursement •$40 million Target Market •PMA likely costs $10s of millions… •Rethink MVP 17 TAM = 400,000 pts SAM = $80 Million Target = $40 Million Source: US Renal Data Service, 2013 Annual Report
- 18. 2 Possible MVPs 18 Coated Graft Stand alone “wrap” FDA: Likely PMA (Predicate CDRH alone) FDA: Likely PMA (CDRH + CDER)
- 19. 2 Possible MVPs 19 Coated Graft Stand alone “wrap” FDA: Likely PMA (Predicate CDRH alone) Existing CPT code coverage FDA: Likely PMA (CDRH + CDER) New HCPC code (~3 yr)
- 20. 2 Possible MVPs 20 Coated Graft Stand alone “wrap” FDA: Likely PMA (Predicate CDRH alone) Existing CPT code coverage FDA: Likely PMA (CDRH + CDER) New HCPC code (~3 yr)
- 21. Drug-eluting Wrap: Workswith Fistulas or AV Grafts 21 Wrap Adapted from Paulson WD et al. Nephrol Dial Transplant (2012);27: 1219-1224 OR Fistula Potential wrap market is ≥ 3X AV Graft market size!
- 22. Design Flaw NearlyDerailed Concept 22 Wrap Adapted from Paulson WD et al. Nephrol Dial Transplant (2012);27: 1219-1224 OR Fistula Interview 82 = potential, “Uh Oh” moment…
- 23. Interview 116 (KOL)Allowed us to Detect and Correct: Wrap Venous Tissue Only 23
- 24. Final Canvas 24 Decision Maker @ Medical Device Co’s Vascular Surgeons, Nephrologists, Interventionalists Dialysis Pts Increase sales Decrease stenosis rates 50% Ease pain & hassle Preclinical studies Large animal studies CROs Value Analysis Committee Licensed IP Licensing Direct Sales CROs SBIR grants Publish: JAMA, Circulation, J VascSurgery, Medical Device Co’s Nat’l Kidney Foundation Center for Devices & Radiological Health Admin Contractor @ CMS KOL Conference: Kidney Week Increase graft life 25% Increase time to 1stintervention 25% Licensing Milestone Payments Affinity’s IP Advisory Board License IP Freedom to Operate IP costs
- 25. Final Canvas CS-VP 25 Decision Maker @ Medical Device Co’s Vascular Surgeons, Nephrologists, Interventionalists Dialysis Pts Increase sales Decrease stenosis rates 50% Ease pain & hassle Licensing Direct Sales Publish: JAMA, Circulation, J VascSurgery, Conference: Kidney Week Increase graft life 25% Increase time to 1stintervention 25%
- 26. Final Canvas KA-KR-KP 26 Preclinical studies Large animal studies CROs Value Analysis Committee Licensed IP Medical Device Co’s Nat’l Kidney Foundation Center for Devices & Radiological Health Admin Contractor @ CMS KOL Affinity’s IP Advisory Board License IP Freedom to Operate
- 27. What’s next? •Freedomto Operate •Continue vetting drug-eluting AV graft and wrap MVPs •Talk with Gore re: interest (possibly Bard) •Cultivate relationship with KOL Dr. Timmy Lee at UAB (Interview 116) •Potential clinical andcommercial relationship. •Use Sales and Medical Science relations to build out KOL and Institutional relationships •Harvard-associated hospitals •Washington University/Barnes-Jewish •University Hospital at Case Medical Center 27
- 28. Phase II SBIRGrant •Affinity plans to submit a Phase II SBIR proposal after a minor pivot. •This proposal will be submitted in 2016 because Affinity has a two year SHIFT award. 28 Investment Readiness Level
- 29. Final Slide –whew! •Final Video on Youtube: http://youtu.be/SYWmiJgDnAs 29 Sean Zuckerman Horst von RecumPaul Olson PI C Level Industry Expert