NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44) | PAR 17 275

Opportunity Information: Apply for PAR 17 275

The NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44) opportunity (Funding Opportunity Number PAR-17-275) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding program aimed specifically at helping small businesses move stroke-related innovations into well-structured human studies. The focus is on generating practical, clinically meaningful evidence in areas where stroke still carries major unmet needs: preventing strokes, treating acute stroke, and improving recovery and rehabilitation after stroke. In plain terms, this announcement is designed for companies that already have a promising intervention or measurement approach and now need to test it rigorously in people, or to complete the critical validation work that makes a clinical trial ready to run.

A central feature of this FOA is its emphasis on clinical trials and trial-enabling biomarker or outcome measure studies. On the clinical trial side, the NIH is looking for both exploratory and confirmatory trials. Exploratory trials are generally earlier-stage studies meant to refine dosing, feasibility, safety, and preliminary signals of benefit, while confirmatory trials are intended to more definitively test whether an intervention works under robust clinical trial conditions. On the biomarker and outcome-measure side, the FOA supports validation studies that are "immediately preparatory to trials," meaning the work should directly support near-term clinical testing rather than open-ended discovery research. This can include validating a biomarker that can stratify patients, predict outcomes, monitor treatment response, or serve as a reliable outcome measure, as well as validating clinical endpoints or measurement tools that make stroke trials more precise and efficient.

The award uses a cooperative agreement mechanism (U44), which signals that NIH expects to have substantial involvement in how the project is carried out, rather than operating purely as a traditional investigator-led grant. Practically, this often means closer coordination with NIH program staff and, in this case, alignment with the NIH StrokeNet infrastructure. The FOA also highlights that projects will be milestone-driven. Milestones are concrete, pre-specified goals that function like go/no-go decision points, helping ensure that the work stays on track and that the funding supports programs that are progressing toward clear clinical deliverables. For small businesses, this structure can be helpful because it forces early clarity on development plans, operational readiness, and what success looks like at each stage of the clinical program.

Eligibility is limited to small business concerns, consistent with SBIR rules, which makes this opportunity distinct from typical academic clinical trial funding. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed, which usually means a U.S. applicant might be able to include certain narrowly justified foreign activities if NIH policy requirements are met and the work is essential to the project. The key point is that the applicant organization must be an eligible U.S. small business, and applicants should be cautious about structuring any international involvement.

From an administrative standpoint, this is a discretionary federal funding opportunity under NIH within the health activity category, listed under CFDA number 93.853. The announcement was created on 2017-05-10, and the original closing date shown is 2018-01-05. The source data does not provide an award ceiling, expected award count, or other budget specifics in the excerpt provided, but the use of a U44 cooperative agreement and the explicit clinical trial focus indicate that NIH is aiming to support serious, execution-ready programs rather than purely conceptual work. Overall, the opportunity is best understood as a pathway for SBIR-eligible companies to leverage NIH StrokeNet and NIH oversight to run milestone-based clinical trials or to validate biomarkers and outcome measures that directly enable those trials in stroke prevention, treatment, and recovery.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2017-05-10.
• Applicants must submit their applications by 2018-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 17 275

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