Download - Affinity I-Corps@NIH 121014
Affinity Therapeutics
Drug delivery grafts for immediate vascular access and reduced failure rates in hemodialysis patients.
Sean T. Zuckerman, Horst von Recum, Paul Olson
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#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
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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
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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 option4
Coated AV Graft for Long Term
Vascular Access
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BLOOD
Time
BLOOD
BLOOD
BloodBLOOD
Normal AV Graft lifespan
BLOOD BLOOD
Smooth muscle cells
AV Graft
Affinity’s coating
Affinity’s Graft lifespan
Steve said…
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So we did…
• Interviewed 128 customers starting with
– Nephrologists
– Vascular Surgeons
– National Kidney Foundation & Kidney Disease Increasing Global Outcomes (KDIGO)
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So we did…
• Interviewed 128 potential customers
– Nephrologists
– Vascular Surgeons
– National Kidney Foundation & Kidney Disease Increasing Global Outcomes (KDIGO)
– Dialysis Clinics
– More nephrologists
– Patients
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Initial Canvas
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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
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Medical Device Co’s
Vascular Surgeons & Nephrologists
Dialysis Pts
Increase sales
Decrease stenosis rates
Ease pain & hassle
Licensing
Acquisition
Publish
Week 2 Canvas
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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
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Neph-rologist
Pt Vascular Surgeon
PtVascular Access
Implanted
Pt
Pt
DIALYSIS!
Pt
Interventionalist
• Nephrologist (loosely) owns the patient
• Vascular surgeons typically choose access type• Sometimes
interventionalist implants
Piggy-Back our MVP on MarketedGore Triple-Layered AcuSeal™
• “Sandwich” coating between layers
• Newer product = smaller market share
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Week 6 Canvas
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Decision Maker @ Medical Device Co’s
Vascular Surgeons,
Nephrologists, Interventionalists
Dialysis PtsIncrease 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 Vasc
Surgery,
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
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Decision Maker @ Medical Device Co’s
Vascular Surgeons,
Nephrologists, Interventionalists
Dialysis PtsIncrease 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 Vasc
Surgery,
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…
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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
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TAM = 400,000 pts
SAM = $80 Million
Target = $40 Million Source: US Renal Data Service, 2013 Annual Report
2 Possible MVPs
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Coated Graft
Stand alone “wrap”
FDA: Likely PMA(Predicate CDRH alone)
FDA: Likely PMA(CDRH + CDER)
2 Possible MVPs
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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
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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
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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
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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
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Final Canvas
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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 IPLicensing
Direct Sales
CROs SBIR grants
Publish: JAMA, Circulation, J Vasc
Surgery,
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 1st
intervention 25%
Licensing
Milestone Payments
Affinity’s IP
Advisory Board
License IP
Freedom to Operate
IP costs
Final Canvas CS-VP
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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 Vasc
Surgery,
Conference: Kidney Week
Increase graft life 25%
Increase time to 1st
intervention 25%
Final Canvas KA-KR-KP
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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 and commercial 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
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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.
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Investment Readiness Level
Final Slide – whew!
• Final Video on Youtube: http://youtu.be/SYWmiJgDnAs
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Sean Zuckerman Horst von Recum Paul OlsonPI C Level Industry Expert