The document discusses Affinity Therapeutics' technology platform for developing microparticle formulations that provide extended local release of antibiotics to prevent surgical site infections. The company was founded in 2010 and is developing formulations to be used with hernia mesh repairs initially, with the goal of licensing the technology to medical device companies. The company has received an NIH Phase I SBIR grant and is working to negotiate licensing and facility agreements with universities.

1. “Affinity-based” microparticle formulations to
prevent surgical site infections by the
extended, local release of antibiotics
2 Minute NSF I-Corps Story

2. Team
 Co-Founder and CSO of Affinity Therapeutics
 Translational Research Associate
Dr. Julius Korley
(EL)
 Co-Founder Affinity Therapeutics
 Associate Professor, Case Western Reserve
University
Dr. Horst von Recum
(PI)
 PFI Advisor/Business Consultant
 Over 30 yrs of experience in roles from bench
scientist to CEO
Dr. Thomas Facklam
(IM)

3. Affinity Therapeutics' Technology
Platform
• A tunable, sustainable drug
release system
• Other applications for our
platform:
– Medical indications are very broad
and include regenerative
medicine, oncology, etc.
– Advanced wound therapy market
– Delivery of anti-cancer drugs and
anti-proliferatives
– Any percutaneous implantable can
be infected; Applicable to most bio-
materials and medical devices

4. History of Affinity Therapeutics
• Founded in November
2010
• PCT Application Published
January 2011
• NIH Phase I SBIR awarded
March 2012 ($400K)
– 5 other Phase I
applications submitted
• Currently negotiating
both an option license
and space agreement Case Western Reserve University
Biomedical Engineering

5. Canvas Version 1 (03/20/2012)
Key Key Value Customer Customer
Partners Activities Studies Propositions Relationships Segments
Formulation
Cyclodextrin supplier Extended local Personal Assistance Surgeons
In vitro analysis
Clinical Collaborators Drug delivery Technical Assistance Wound Therapy
In Vivo analysis
Medical Device Cos. Bioavailable and Specialists
Large Animal Models
Manufacturers Unmodified Hospitals
Pre-Clinical Studies
Infection Reduction
Non-Dilutive Funding
Cost Reduction
Clinical
Increase “Quality of
Collaborations
Life”
Regulatory Path
IDE Submission
Key Resources Channels
Intellectual Property Infrastructure of
Access to developers Strategic Partners
of technology Such as Medical
Device cos. Or “Big
Pharma”
Cost Structure Revenue Streams
ISO 10993 analysis SBIR
Clinical Trials Licensing
Manufacturing Co-Development
Strategic Partnerships

6. What We Thought…
– Be a medical device company focusing on at least
5 different indications
– Our customer was the physicians or surgeons
– Gain device approval from the FDA
– Manufacture the product (open our own plant)
– Distribute the product (customer acquisition)
– Sale the product (huge sales team)
– Get reimbursement from both Medicare and
private insurance

7. Customers interviewed to test…
Medical Device Consulting
Associate Director
Research Scientist
10 10
Other companies
Program Manager Associate Director
Director, R&D
Director, R&D Marketing Manager
80

8. Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
CROs Key Partner Cost Reduction Personal and Medical Device
Medical Device Pre-Clinical Study Prophylaxis of Technical Companies
Companies Fund Raising Hernia Mesh Assistance • (Exclusivity for
• Hernia Mesh Clinical • Educating EU initial
Repair Infection
• General Dev. Collaborations “Market-driven indication)
Regulatory studies”
Support of KP’s
marketing plan
Key Channels
Resources
Infrastructure of
IP Strategic Partners
Access to (as Med. Dev. Co.)
developers
of technology
Cost Structure Revenue Streams
CRO’s, CMO’s, Regulatory, Strategic Licensing, Royalties, Co-Development
Marketing, Education and Branding Milestone payments, Strategic
Partnerships

9. Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
CROs Key Partner Cost Reduction Personal and Medical Device
Medical Device Pre-Clinical Study Prophylaxis of Technical Companies
Companies Fund Raising Hernia Mesh Assistance • (Exclusivity for
• Hernia Mesh Clinical Repair Infection • Educating EU initial
• General Dev. Collaborations “Market-driven indication)
Regulatory studies”
Support of KP’s
marketing plan
Key Channels
Resources
Infrastructure of
IP Strategic Partners
Access to (as Med. Dev. Co.)
developers
of technology
Cost Structure Revenue Streams
CRO’s, CMO’s, Regulatory, Strategic Licensing, Royalties, Co-Development
Marketing, Education and Branding Milestone payments, Strategic
Partnerships

10. Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
CROs Key Partner Cost Reduction Personal and Medical Device
Medical Device Pre-Clinical Study Prophylaxis of Technical Companies
Companies Fund Raising Hernia Mesh Assistance • (Exclusivity for
• Hernia Mesh Clinical Repair Infection • Educating EU initial
• General Dev. Collaborations “Market-driven indication)
Regulatory studies”
Support of KP’s
marketing plan
Key Channels
Resources
Infrastructure of
IP Strategic Partners
Access to (as Med. Dev. Co.)
developers
of technology
Cost Structure Revenue Streams
CRO’s, CMO’s, Regulatory, Strategic Licensing, Royalties, Co-Development
Marketing, Education and Branding Milestone payments, Strategic
Partnerships

11. Market Research
• Surgical Site Infections (SSIs)
– Market Size
• SSIs occur in 1.5 million surgeries annually1
• $10 billion in annual U.S healthcare expenditures1
• SSIs account for16% of hospital-acquired infections2
– Market Drivers
• SSIs not reimbursable
• Growing patient population in U.S.
• Prevention of infection and prevention of readmission (40%) 2
• Reduction of SSI incidence ratios by 25% by 20142
– Market Dynamics
• Surgical Infection Prevention project (2002)
– Reduce SSIs by 90%2
• New CDC standards on prevention and regulation
• Diverse application opportunities
1. Frost and Sullivan - Surgical Site Infections Pose Serious Threat and Increase Demand for Advanced Infection Control Technologies
2. http://www.nj.gov/health/healthfacilities/presentations/prevention_lindenauer.pdf

12. Market Opportunity Hernia Mesh
Repair
TAM=$1.1B
Hernia Mesh repair
SAM = $650M
Ventral Hernias
TM ≤ $650M

13. Lessons Learned about Value Prop
• Needs= prevention of SSI
– Synthetic Mesh vs. Biological Mesh
– Antimicrobial mesh sold by Gore
– Protection that lasts 7-21 days
• Solution= Affinity Therapeutics’ Antimicrobial
formulation
– Formulated to be used with the stronger synthetic
meshes
– antimicrobial activity for ~30 days

14. Lessons Learned about Value Prop
• We thought that SSIs were a big problem
– We asked several the customers
• This was confirmed but other markets proposed
– So we move forward
• We thought, “Focus on the total SSI Market”
– We spoke with clinicians and industry experts and
ran the numbers
• We decided it best to focus on one market
– We chose the Hernia Mesh Market

15. Regulatory Pathways (Class II)
Stage 1 Safety study Stage 2 Effectiveness trial
$3-5MM
US 510(k)
$2-3MM
US IDE 1-2YR 30 patients
$5-8MM
2-4YR
1-2YR
Regulatory Pathways (Class III)
Stage 1 Stage 2 Stage 3
Preclinical study Pilot trial Pivotal trial
$3-5MM $15-22MM US PMA
$2-3MM
US IDE 30 patients 150 patients $20-30MM
1-2YR 4-7YR
1-2YR 2-3YR

16. Lessons Learned about Key Partners
• Critical for the following:
– Regulatory hurdles
– Clinical trials
– Reimbursement
– Manufacturing
– Distributions
– Marketing
– Market penetration and Customer Acquisition
• Our new target is technology to “Proof of
Concept” then partner

17. Lessons Learned about Key Partners
• What Makes Affinity an attractive partner?
– True Platform technology
• Why will the partner? Customer Relationships
– Have established relationships that they would
like to cultivate (i.e. surgeons or other clinical
collaborators)
• At what cost to us?
– Exclusivity vs. “Right to play”

18. Business Ecosystem
Case Western
FDA
Reserve TTO
Patients Surgeons
Affinity Strategic
Therapeutics Partner/OEM Hospitals
Clinical
Contract
Collaborators Distributors
Manufacturers
= Revenue/Feedback
= Information/Product

19. Business Ecosystem (In Hospital)
Group
Purchasing
Org. (GPO)
Reimbursement
Affinity Strategic
Strategic Insurance
Hospitals
Therapeutics PartnersPartners Companies
Co-Pays
Services Other fees Insurance
Rendered Premiums
= Revenue/Feedback Patients
= Information/Product

20. Business Ecosystem (In Hospital)
Group
Purchasing
Org. (GPO)
Reimbursement
Affinity Strategic
Strategic Insurance
Hospitals
Therapeutics PartnersPartners Companies
Co-Pays
Services Other fees Insurance
Rendered Premiums
= Revenue/Feedback Patients
= Information/Product

21. Newly Refined Business Strategy
• True Platform technology
– Multiple products with broad range of uses and
clinical indications
• Exclusivity on Hernia Mesh Repair infection
only to provide revenue for product
development in other areas
• Company owned products

22. Summary
• Capital Efficiency
– Using CROs
– Strategic Partners
• Targeting growing unmet needs
– Hernia Mesh market continues to increase
• Obesity and age
• License initial products to strategic partners
and retain right to market future products
under Affinity brand

23. Affinity is Open for Business!
Future Home of Affinity Therapeutics

24. Canvas Version 1 (03/20/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Formulation Studies
Cyclodextrin supplier Extended local Personal Assistance Surgeons
In vitro analysis
Clinical Collaborators Drug delivery Technical Assistance Wound Therapy
In Vivo analysis
Medical Device Cos. Bioavailable and Specialists
Large Animal Models
Manufacturers Unmodified Hospitals
Pre-Clinical Studies
Infection Reduction
Non-Dilutive Funding
Cost Reduction
Clinical
Increase “Quality of
Collaborations
Life”
Regulatory Path
IDE Submission
Key Resources Channels
Intellectual Property Infrastructure of
Access to developers Strategic Partners
of technology Such as Medical
Device cos. Or “Big
Pharma”
Cost Structure Revenue Streams
ISO 10993 analysis SBIR
Clinical Trials Licensing
Manufacturing Co-Development
Strategic Partnerships

25. Canvas Version 1 (03/21/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Cyclodextrin Formulation Extended local Personal Surgeons
supplier In vitro and in vivo Drug delivery Assistance Wound Therapy
Clinical analysis Bioavailable and Technical Specialists
Collaborators Pre-Clinical Study Unmodified Assistance Hospitals
Medical Device Fund Raising Infection --Surgeons
Cos. Clinical Collab. Reduction --Wound Therapy
Manufacturers Regulatory ANDA Device capable of Specialists
IDE Submission preventing Outpatient Surgery
Key infection without
Channels
Centers
Resources impacting surgery Medical Dev. Cos.
Infrastructure of
IP Cost Reduction Veterinary Med.
Strategic Partners
Access to Increase “Quality
(as Med. Dev. Co.
developers of Life”
or “Big Pharma”
of technology
Cost Structure Revenue Streams
ISO 10993 analysis SBIR
Clinical Trials Licensing
Manufacturing Co-Development
Strategic Partnerships

26. Canvas Version 1 (03/22/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Cyclodextrin Formulation Device capable of Personal Surgeons
supplier In vitro and in vivo preventing Assistance Wound Therapy
Clinical analysis infection without Technical Specialists
Collaborators Pre-Clinical Study impacting surgery Assistance Veterinary Med.
Medical Device Fund Raising Cost Reduction Hospitals
Cos. Clinical Collab. Increase “Quality --Surgeons
Manufacturers Regulatory ANDA of Life” --Wound Therapy
IDE Submission Prophylaxis of SSI Specialists
Key Channels
Outpatient Surgery
Resources Centers
Infrastructure of
IP Medical Dev. Cos.
Strategic Partners
Access to Insurance Cos.
(as Med. Dev. Co.
developers Medicare
or “Big Pharma”
of technology
Cost Structure Revenue Streams
ISO 10993 analysis SBIR
Clinical Trials Licensing
Manufacturing Co-Development
Strategic Partnerships

27. Canvas Version 1 (03/28/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Cyclodextrin Pre-Clinical Study Cost Reduction Personal Hospitals
supplier Fund Raising Prophylaxis of SSI Assistance --Surgeons
Clinical Clinical Collab. Technical Medical Dev. Cos.
Collaborators Regulatory Assistance Insurance Cos.
Medical Device IDE Submission Medicare
Cos.
Manufacturers
Key Channels
Resources
Infrastructure of
IP Strategic Partners
Access to (as Med. Dev. Co.
developers or “Big Pharma”
of technology
Cost Structure Revenue Streams
ISO 10993 analysis Licensing
Clinical Trials Co-Development
Manufacturing Strategic Partnerships

28. Canvas Version 1 (04/04/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Cyclodextrin Pre-Clinical Study Cost Reduction Personal Hospitals
supplier Fund Raising Prophylaxis of Assistance --Pharmacy and
Clinical Clinical Hernia Mesh Technical Therapeutics
Collaborators Collaborations Repair Infection Assistance Committee
Medical Device Regulatory • Educating EU --Surgeons
Companies (Class 1 or 2 vs. 3) Medical Dev. Cos.
• Hernia Mesh US vs. EU Insurance Cos.
• General Dev. IDE Submission Medicare
Key Channels
Contract
Manufacturers Resources
Infrastructure of
Regulatory IP Strategic Partners
Consultant Access to (as Med. Dev. Co.
developers or “Big Pharma”
of technology
Cost Structure Revenue Streams
ISO 10993 analysis Licensing
Clinical Trials Co-Development
• 30 days; end point infection rate Strategic Partnerships
Manufacturing, Distribution. Education of EU

29. Canvas Version 1 (04/11/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Cyclodextrin Key Partner Cost Reduction Personal and Hospitals
supplier Pre-Clinical Study Prophylaxis of Technical --Pharmacy and
Clinical Fund Raising Hernia Mesh Assistance Therapeutics
Collaborators Clinical Repair Infection • Educating EU Committee
Medical Device Collaborations “Market-driven --Surgeons
Companies Regulatory studies” Medical Dev. Cos.
• Hernia Mesh (Class(1-3), USvsEU Support of KP’s Insurance Cos.
• General Dev. IDE Submission marketing plan Medicare
Key Channels
Contract
Manufacturers Resources
Infrastructure of
Regulatory IP Strategic Partners
Consultant Access to (as Med. Dev. Co.
developers or “Big Pharma”
of technology
Cost Structure Revenue Streams
ISO 10993 analysis, Clinical Trials Licensing, Royalties, Co-Development
• 30 days; end point infection rate, Milestone payments, Strategic
Manufacturing, Distribution, Education of EU Partnerships

30. Canvas Version 1 (04/18/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Cyclodextrin Key Partner Cost Reduction Personal and Medical Device
supplier Pre-Clinical Study Prophylaxis of Technical Companies
Clinical Fund Raising Hernia Mesh Assistance • (Exclusivity for
Collaborators Clinical Repair Infection • Educating EU initial
Medical Device Collaborations “Market-driven indication)
Companies Regulatory studies” Group Purchasing
• Hernia Mesh (Class(1-3), USvsEU Support of KP’s Organizations
• General Dev. IDE Submission marketing plan Hospitals
Key Channels
--Pharmacy and
Resources Therapeutics
Infrastructure of
IP Committee
Strategic Partners
Access to --Surgeons
(as Med. Dev. Co.
developers Medical Dev. Cos.
or “Big Pharma”
of technology Insurance Cos.
Medicare
Cost Structure Revenue Streams
ISO 10993 analysis, Clinical Trials Licensing, Royalties, Co-Development
• 30 days; end point infection rate, Milestone payments, Strategic
Manufacturing, Distribution, Education of EU Partnerships

31. Canvas Version 1 (04/25/2012)
Key Key Value Customer Customer
Partners Activities Propositions Relationships Segments
Cyclodextrin Key Partner Cost Reduction Personal and Medical Device
supplier Pre-Clinical Study Prophylaxis of Technical Companies
Clinical Fund Raising Hernia Mesh Assistance • (Exclusivity for
Collaborators Clinical Repair Infection • Educating EU initial
Medical Device Collaborations “Market-driven indication)
Companies Regulatory studies” Group Purchasing
• Hernia Mesh (Class(1-3), USvsEU Support of KP’s Organizations
• General Dev. IDE Submission marketing plan Hospitals
Key Channels
--Pharmacy and
Resources Therapeutics
Infrastructure of
IP Committee
Strategic Partners
Access to --Surgeons
(as Med. Dev. Co.
developers Medical Dev. Cos.
or “Big Pharma”
of technology Insurance Cos.
Medicare
Cost Structure Revenue Streams
ISO 10993 analysis, Clinical Trials Licensing, Royalties, Co-Development
• 30 days; end point infection rate, Milestone payments, Strategic
Manufacturing, Distribution, Education of EU Partnerships