requisite biomedical i-corps@nih 121014

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

“Yeah, I got out of

the building and

look what it got

me…. wish I were

there.”

6

Business Model Canvas – Earliest Version

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

Business Model Canvas – Next Version

EXPANDED

AND

QUANTIFIED

ADDED

REAL

PEOPLE

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

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

Business Model Canvas – Current Version

+ 4 MORE

+ 3 MORE

CATEGORIZED

ADDED

REVISED

PRIORITIZED

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

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

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

Business Model Canvas Evolution

16

17

18

19

20

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

Find ReQuisite Biomedical on

YouTube