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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
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
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
Vascular Access 
•Long term vascular access critical for hemodialysis 
•Arteriovenous (AV) grafts common but suboptimal option 
4
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
Steve said… 
6
So we did… 
•Interviewed 128 customers starting with 
–Nephrologists 
–Vascular Surgeons 
–National Kidney Foundation & Kidney Disease Increasing Global Outcomes (KDIGO) 
7
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
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
Initial Canvas 
10 
Medical Device Co’s 
Vascular Surgeons & Nephrologists 
Dialysis Pts 
Increase sales 
Decrease stenosis rates 
Ease pain & hassle 
Licensing 
Acquisition 
Publish
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
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
Piggy-Back our MVP on MarketedGore Triple-Layered AcuSeal™ 
•“Sandwich” coating between layers 
•Newer product = smaller market share 
13
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%
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%
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
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
2 Possible MVPs 
18 
Coated 
Graft 
Stand alone “wrap” 
FDA: Likely PMA 
(Predicate CDRH alone) 
FDA: Likely PMA 
(CDRH + CDER)
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)
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)
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!
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…
Interview 116 (KOL) Allowed us to Detect and Correct: Wrap Venous Tissue Only 
23
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
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%
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
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
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
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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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
  • 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