BRAIN Initiative: SBIR Direct to Phase II Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)
The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue a small clinical study to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and thereby better understand the human brain (e.g., Early Feasibility Study).Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants.The clinical study should provide data to answer key questions about the function or final design of a device.This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval.The clinical study is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical study to answer key questions about the function or final design of a device.
General information about this opportunity
Last Known Status
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Number of Awards Available
Who is eligible to apply/benefit from this assistance?
Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
What is the process for applying and being award this assistance?
Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements.
Who do I contact about this opportunity?
NIH OER Webmaster
Range and Average of Financial Assistance
Awards up to $1,500,000.00