Form 1 Application to Participate in Industry and Investor Show

OMB#: 0925-0740
Exp Date: 5/31/2019

Application for NIH Support to Participate in Industry and Investor
Showcase Events
Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0740). Do not return the completed form to this
address.

By submitting this application, you are providing permission to share its contents with external investors, potential
strategic partners, and expert reviewers. You are also certifying that you have not included confidential information
that you do not wish to share with non-NIH experts.
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Award Information
Provide the NIH SBIR/STTR award numbers (grant/contract) for the one (1) technology or product that you would
like to present. If the award is an STTR grant, please indicate the name of the affiliated university.
Grant/Contrat Number:
Affiliated University:
Company Information
Official Company Name:
Alternative or Former Company
Name(s):
Corporate Structure:
Company Address:
Company Website:
Current Number of Employees
(total full-time equivalents [FTEs])
Company CEO:

Company Representative for
Conference Participation:
Years company has been in
business:
Is the company a spinoff of
another company?
Is the company currently
generating revenue?

LLC

C-Corp

S-Corp

Sole Proprietorship

Name:
Phone:
E-mail:
Name and Title:
Phone:
E-mail:

Yes
No
If “Yes”, please give name of parent company:
Yes
No
If “Yes”, please indicate dollar range of your company’s sales revenues from
products/services for the past year (include sales and licensing revenues)
R&D Grant/Contracts:
Sales from Products and Services:
Licensing Fees and Royalties:

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OMB#: 0925-0740
Exp Date: 5/31/2019

Executive Summary:
Please provide a brief description of the company and your technology. Describe the management team’s experience in
commercializing biomedical technologies, if any. Please use no more than 250 words.

Technology/Product Overview:
1. Select the one category that best describes the technology/product that will be presented:
Therapeutic – Small Molecule
Therapeutic – Device
Diagnostic - Software
Therapeutic – Biologic (protein/peptide)
Diagnostic – Device (Image-related)
Companion Product
Therapeutic – Biologic (cell)
Diagnostic – Device (other)
Health IT
Therapeutic – Biologic (gene)
Diagnostic – In Vitro
Research Tool
Therapeutic – Biologic (other)
Diagnostic – Imaging Agent
Production Tool
2. Please describe the technology/product that was funded by the NIH.

Scientific Progress and Stage of Development:
Please check the appropriate boxes.
FDA Marketing Pathway:

PMA

510(k)

BLA

NDA

Not Applicable (non-regulated product)

FDA Application Status:
IND/IDE:
Not yet submitted
510(k)/PMA:
Not yet submitted

Submitted
Submitted

Clinical Development Status:

Preclinical

Phase I

Phase II

Phase III

Device Class:

1

2

3

Not Applicable

Approved
Cleared/Approved
Not Applicable

1. Describe your product development progress (pre-clinical or clinical) and major technical objectives achieved to
date.

2. Provide a brief overview of the regulatory strategy for the product under development. Describe current and future
regulatory applications, approvals, and hurdles.

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OMB#: 0925-0740
Exp Date: 5/31/2019

Intellectual Property:
1. List the most relevant issued and pending patent applications covering the product or technology (including
provisional patent applications). If applicable, provide the name(s) of the institution(s) from which the IP was
licensed and key non-confidential license terms.

2. List any trademarks or copyrights. (Please enter numeric values where applicable.)
# Filed

# Approved

Subject matter or name of mark

Trademarks
Copyrights

3. Describe your company’s strategy to generate and protect its intellectual property.

Market Description, Go-to-Market Strategy and Projected Revenues:
1. Describe the customer(s) and market segments for the product or service under development. Based on projected
customer adoption, estimate the peak market size in dollars. Proved projected revenue and expected timeframes.

2. Explain how your product addresses an unmet need. What, if anything, do customers use now to meet this need?

3. Describe how you plan to commercialize the product. What is your “go-to-market” strategy (i.e. how will you get
your product into customers’ hands)?

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OMB#: 0925-0740
Exp Date: 5/31/2019

Competitive Advantage:
1. Describe the competitive advantages of the product over both currently marketed products and products under
development.

2. What are the anticipated barriers to adoption of your product?

Management Team:
List all current and pending management and key personnel in the company or collaborating with the company and
describe their relevant expertise, experience, and previous success.

Business Development and Partnerships:
1. Are you currently seeking a partner to assist with the development and/or commercialization of the product?
Yes
No
2. If Yes, please indicate what kind of partnership(s) you are seeking (e.g., strategic, product development,
manufacturing, distribution, etc.).

3. Describe any current or pending collaboration, development, license or strategic partnership agreements that the
company has related to the product.

4. Please list any spin-offs from the company. If none, state “N/A”.

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OMB#: 0925-0740
Exp Date: 5/31/2019

Capital Raised To-Date:
List the source and amount of all capital that the company has raised since inception. In-kind support and its estimated
value may also be included.
Date

Type

Source(s)

Amount

Future Investments:
1. Is the company currently seeking investments?

Yes

No

2. If Yes, describe the company’s current fundraising activity and goals, including amount sought, intended use of
funds, and potential sources of funding.

Company Milestones:
List major product development and commercial milestones achieved and/or expected over the next 24 months:
Milestone
Date

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OMB#: 0925-0740
Exp Date: 5/31/2019

Publications, Presentations, and Awards:
List any significant past and pending publications, presentations and awards based on the company’s technology.
Please limit publication list to 5 articles, however a link to the full publication history may be provided.

Conference Goals
What is your primary goal for attending and presenting at the conference?
Seeking strategic partners (large business)
Seeking investment
Seeking scientific collaborators
Customer discovery
Increasing company visibility and exposure
Gaining insight into competition and/or IP landscape
Validating your business model
Other, describe:
What would you like to get from participating in the event?

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