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Affinity I-Corps@NIH 121014

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I-Corps @ NIH

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Affinity I-Corps@NIH 121014

  1. Affinity Therapeutics Drug delivery 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 thought initially •~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 thought initially •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 •Long term vascular access critical for hemodialysis •Arteriovenous (AV) grafts common but suboptimal option 4
  5. Coated AV Graft for 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. Steve said… 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 Patient Workflow 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 MVP on 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 Graft Market •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 Graft Market •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: Works with 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 Nearly Derailed 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? •Freedom to 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 SBIR Grant •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

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