I-Corps @ NIH

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