I-Corps @ NIH

1. 1
Intravascular medical device drug coatings
that promote vascular healing

2. 2
Intravascular medical device drug coatings
that promote vascular healing
Plavix

3. 3
Total Interviews = 108
Average = 10 per week
Investor Readiness = 4

4. 4
Margaret E (Meg) Groh, PhD/MBA -- CEO
•Biotechnology business development experience
•NSF I-Corps graduate (U Akron)
• Tammy “The Tamminator” Dugas, PhD -- PI
•Professor, LSU School of Veterinary Medicine
•Cardiovascular pharmacologist/toxicologist
•Co-Founder John D. Foley, PhD -- IE
•Medical device industry executive
•Co-Founder

5. 5
“Yeah, I got out of the building and look what it got me…. wish I were there.”

6. 6
Business Model Canvas – Earliest Version

7. 7
SO HERE’S WHAT WE DID…
First 20 Interviews
KOL
REGULATORY
REIMBURSEMENT
CLINICIAN
•Stent versus balloon decision needs more input
•Clinical trial design/cost and market size will guide preclinical decisions (stent v balloon, coronary v peripheral)
•Regulatory hurdle is significant, yet Drug Master Files already exist

8. 8
Business Model Canvas – Next Version
EXPANDED AND QUANTIFIED
ADDED
REAL PEOPLE

9. 9
SO HERE’S WHAT WE DID…
SO HERE’S WHAT WE FOUND…
Next set of interviews
DECISION MAKERS
HOSPITAL SALES REPS
CLINICIANS
•Hospital product technology assessment committees have a key role in new product adoption
•HOWEVER, with strong data clinicians can advocate for a new product and prevail
$$!!

10. 10
CUSTOMER RELATIONSHIPS
Hypothesis
Interviews
Learnings
Actions
Clinicians will drive uptake.
Vascular surgeon (2 this week, 4 total)
Interven’l Cardiologist (1 this week, 3 total)
“Show me the study.” Docs are very data-driven.
Will need to publish in high impact journals, present at major meetings, utilize other media.
FDA is a key customer.
FDA employee or consultants (2 this week, 12 total)
Major hurdle that can be overcome with time, patience, data, and $.
Engage regulatory expertise in Phase II.
Business development folks are a key customer and gatekeeper.
Business dev at potential partner (1 this week, 4 total)
Business dev at potential collaborator (2 this week, 5 total)
Large number of ways to partner.
Need to draw out likely possibilities then prioritize.
Investors (VCs) will not take on this deal
VC (1 this week, 10 total)
WRONG! VCs will look at any deal, even a PMA. It’s the technology, deal structure, and market size that matter.
Keep VC/other equity investors in mind, especially with regard to deal structure in partnerships.
FTO will allow unrestricted sales
IP attorneys (2 this week, 8 total)
Confirmed. Details on when & how evolving.
Will conduct FTO and set up ongoing maintenance in IP surveillance space.

11. 11
Business Model Canvas – Current Version
+ 4 MORE
+ 3 MORE
CATEGORIZED
ADDED
REVISED
PRIORITIZED

12. 12
VS
 Not necessarily a Pivot, but a new set of Priorities
 Need to accelerate development of the drug coated balloon
•Longer regulatory pathway
•Second line of therapy
•Market size trending downward
•Shorter regulatory pathway
•First line of therapy
•Market size trending upward

13. 13
WHERE WE ARE NOW…
•We have learned that we need to think ahead, find the ‘customers’ and find out what drives their decisions.
•It is OK to pivot or re-prioritize. Both come with a new set of VPs and KAs.
•We have reaffirmed that we have a viable business and we will pursue it diligently after this class.

14. 14
With respect to submitting an SBIR/STTR Phase II application, we are making the following decision:
Go with a nominal pivot: The feasibility data generated in the Phase I grant provide the appropriate technical foundation for a Phase II application, AND we are largely targeting the customer segments that we had originally anticipated
Investment Readiness Level (IRL) = 4

15. 15
Business Model Canvas Evolution

16. 16

17. 17

18. 18

19. 19

20. 20
https://www.youtube.com/watch?v=OWTpIfKPivg&feature=youtu.be
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