Innovative Medical Solution Commercialization Proposal

1. (Title of Proposal) Proposal Presentation to the Project Management and Oversight Panel __(date of Presentation)__

2. Lead investigator name University Department Contact Information Collaboration Partners Industry leader name Company Title Contact Information Lead investigator name University Department Contact Information Funding Requested: $ Source(s) of matching funding and indicate if these funds are (a) committed, and (b) available

3. Executive Summary • What is the large unmet need? • What is the product or service to be commercialized? • What is the business opportunity? • What is the timeline to commercialization?

4. Statement of Unmet Need State the medical / life science problem or unmetneed Explain: • number of individuals are impacted (U.S. & worldwide) • associated costs • size of the market (potential total annual sales of product / service)

5. Current Market Conditions • What is the current solution / process / standard of care / etc. that exists in the market today? • What are the gaps or problems with the current approach(es)

6. Proposed Solution • Explain the proposed product or service to be commercialized • Why is the proposed solution innovative / unique / novel / cutting edge • How does your proposal create a better solution

7. Scientific and Technical Basis • Explain the underlying science / technology that supports development of the proposed solution

8. The Team Who is on the team and what is their experience and expertise regarding achieving the critical elements required to succeed, i.e. mission-critical areas such as: • technology development, product development, commercialization, regulatory, reimbursement, etc. Explain the team’s: • communication plan • accountabilities for achieving milestones • plan to declare and solve communication / teamwork breakdowns • management and leadership experience for addressing both current and future needs and /or the plan for recruiting the talent required

9. Product Development Plan • What is the proposed solution’s current status/stage of technology or product development • What are the key steps in the product development plan • What are major risk factors to success of this plan • What is the plan to mitigate these risks • What is the status and plan for meeting applicable regulatory and reimbursement requirements

10. Key Objectives for Product Development Use the following template to provide objective steps, estimated timelines and budget required to reach the proposed solution

11. Commercialization Plan • Describe the business (manufacturing / service / license IP / hybrid / etc.) • Who are the target customers • What is the value proposition • How will the product / service be marketed and distributed

12. Competitive Advantage and IP Strategy • Who are the current competitors / potential competitors • What is the competitive advantage / what barriers to (competitors’) entry are in place: • Status of freedom to operate • Current intellectual property (to whom it belongs) • Pending patents / applications • What is the patent strategy going forward

13. Revenue Plan • How will pricing be determined • What is the revenue plan • If reimbursement relies on billing codes from Healthcare Common Procedural Coding System (HCPCS), are these codes already in place / or is there a plan to obtain?

14. Financial Plan • What is the plan to reach profitability and/or raise follow-on funding • What are the probable sources for follow-on funding (NIH, STTR/SBIR, Angel funding, venture capital, corporate partnerships, etc.) • How much capital is required to get to market • How much capital is required to reach cashflow breakeven

15. Economic Impact for Virginia • Given success, how will this project impact economical development in Virginia: • job creation • in the first 3 years, • in years 4-7 • how much capital will be raised • in the first 3 years • in years 4-7 • what are projected profits in years 5-7 • other

16. Summary • What are the key reasons this project should be funded?