BRAIN Initiative: SBIR Direct to Phase II Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44) | RFA NS 17 008

Opportunity Information: Apply for RFA NS 17 008

The BRAIN Initiative SBIR Direct to Phase II FOA, titled "Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)" (RFA-NS-17-008), is a National Institutes of Health funding opportunity aimed at helping small business concerns move advanced neurotechnology into a small, targeted human clinical study. It is structured as a Direct to Phase II Small Business Innovation Research award using a cooperative agreement mechanism (U44), which typically means NIH program staff will have substantial involvement during the project period compared with a standard grant. The overall goal is to accelerate the development of invasive devices that can record from and/or stimulate the human central nervous system, with an emphasis on generating practical, decision-making data that supports device refinement and future clinical development for central nervous system disorders, while also contributing to a better understanding of the human brain.

The core activity supported under this opportunity is a small clinical study, often described as an early feasibility study, designed to answer key questions about device function, usability, safety, performance, or final design requirements. The intent is not to fund large pivotal trials, but rather to support the kind of focused human testing that helps a company determine whether the device works as intended in real clinical conditions and what modifications are needed before moving toward larger trials and eventual regulatory clearance or approval. A major theme of the FOA is that the clinical study should produce information that cannot realistically be obtained through additional non-clinical work, such as benchtop testing or animal studies, because the device or its intended use is novel and human data are required to resolve the most important uncertainties. In other words, the funding is meant to bridge the point where traditional preclinical testing is no longer sufficient, but where early human experience can significantly de-risk the development path.

The FOA explicitly allows for different risk categories of studies, reflecting the realities of invasive neurotechnology development. It may support acute or short-term procedures that an Institutional Review Board determines to be Non-Significant Risk (NSR), as well as Significant Risk (SR) clinical studies that require an Investigational Device Exemption from the U.S. Food and Drug Administration, including studies involving chronic implants. This flexibility matters because some next-generation recording and stimulation systems are intended for brief intraoperative use, while others are designed for longer-term implantation, and the regulatory and oversight requirements differ accordingly. Regardless of whether the study is NSR or SR, the expectation is that the work will be tightly linked to a clear set of engineering and clinical questions that directly inform the final device design.

From a development standpoint, the FOA positions the supported study as a late-stage step toward more advanced clinical trials and market pathways. It highlights that the "final device design" evaluated or informed by the study may require most, if not all, of the non-clinical testing needed on the path to later clinical trials and eventual marketing authorization. That framing signals that applicants should already have made substantial technical progress and should be prepared to justify why they are ready for a human study now, what specific design decisions the study will support, and how the results will be used to advance the product toward broader clinical validation and commercialization. The emphasis is on practical translation: producing high-value evidence that meaningfully advances the device, not simply generating exploratory academic insights.

Eligibility is limited to small businesses, consistent with the SBIR program. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components, as defined by NIH Grants Policy, may be allowable in some cases, which typically implies that limited, well-justified foreign involvement could be permissible if it is essential to the project and consistent with NIH policy, but the applicant organization itself must be U.S.-based and meet SBIR small business requirements. The opportunity is categorized as discretionary funding, and it lists multiple CFDA numbers associated with NIH neuroscience and related institute programs (including 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the cross-institute nature of BRAIN Initiative activities.

In terms of basic administrative details, the FOA was created on September 28, 2016, with an original closing date of May 24, 2017, and it anticipated making around five awards. While the specific award ceiling is not stated in the provided text, the combination of "Direct to Phase II" and "small clinical study" signals that NIH expected applicants to propose a well-developed, comparatively mature project plan appropriate for human testing, including regulatory strategy (IRB determinations and, where applicable, IDE planning), clinical site readiness, and a clear pathway for using study outcomes to finalize the device and move to the next regulatory and clinical milestones.

Overall, this grant opportunity is best understood as targeted support for a small business that has a next-generation invasive CNS recording and/or modulation technology that is far enough along to justify early human evaluation, and that needs that human study specifically to answer concrete questions about device function and final design. The BRAIN Initiative context underscores the dual-purpose value: enabling better treatments for neurological or psychiatric disorders through improved neurotechnology, and enabling new capabilities for understanding human brain function through advanced recording and stimulation tools.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: SBIR Direct to Phase II Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2016-09-28.
• Applicants must submit their applications by 2017-05-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 5 candidate(s).
• Eligible applicants include: Small businesses.

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