Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection- Interventions from Small Businesses (U44 Clinical Trial Not Allowed) | RFA NS 22 033

Opportunity Information: Apply for RFA NS 22 033

The Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection - Interventions from Small Businesses (RFA-NS-22-033) is a National Institutes of Health (NIH), NINDS funding opportunity that uses a cooperative agreement mechanism (U44) to support Phase II SBIR projects focused on preclinical stroke therapy development. The central goal is to move the most promising acute cerebroprotective interventions closer to human testing by putting them through rigorous, standardized, and parallel evaluation in well-established experimental models of ischemic stroke. This FOA is explicitly not for clinical trials; it is meant to strengthen and de-risk the preclinical evidence base so that only the strongest candidates advance toward later-stage clinical development.

In practical terms, SPAN is designed as a coordinated, multi-site preclinical testing network that can evaluate up to eight interventions. The interventions of interest are cerebroprotective drugs, biologics, devices, or other strategies intended to protect brain tissue during an ischemic stroke, particularly when administered before reperfusion or right around the time blood flow is restored. That timing matters because modern stroke care increasingly relies on reperfusion therapies (such as thrombectomy and thrombolysis), and there is a major clinical need for add-on treatments that can limit injury during and after the restoration of blood flow. The FOA highlights experimental ischemic stroke paradigms such as transient middle cerebral artery occlusion (tMCAo), a commonly used model that mimics a blocked cerebral artery followed by reperfusion, allowing researchers to study both ischemic damage and reperfusion-related injury.

A key feature of this opportunity is that awardees do not operate in isolation. Successful applicants become part of the SPAN consortium and are expected to collaborate closely with three major partner components: the SPAN Coordinating Center (supported under RFA-NS-22-004), the network testing laboratories (supported under RFA-NS-22-003), and other intervention contributors (RFA-NS-22-032). This structure is meant to make the evaluation process more efficient and more credible by using shared protocols, coordinated project management, and harmonized outcome measures across sites, while enabling multiple candidate therapies to be tested in parallel. Because the funding instrument is a cooperative agreement, NIH and network leadership typically have substantial involvement in shaping milestones, coordinating work across the network, and ensuring that the studies meet agreed-upon rigor and transparency expectations.

Applicants are expected to bring a promising cerebroprotective intervention with strong justification for why it should be tested in this network. The FOA emphasizes that the intervention should be supported by rigorous and extensive preliminary data, meaning the project should not be speculative or early-concept. Instead, the small business should already have convincing preclinical evidence suggesting the therapy is ready for a more definitive, network-based assessment. The intent is to use SPAN as a translational "stress test" that can validate (or rule out) candidates with a level of rigor that is often difficult for a single small business to achieve alone due to cost, time, and the need for independent replication.

If SPAN works as intended, the payoff is a clearer, faster path to identifying which cerebroprotective strategies truly merit expensive pivotal clinical trials. Stroke neuroprotection has historically been an area where many candidates looked promising early on but later failed to translate; this network approach is meant to reduce that risk by standardizing testing, improving reproducibility, and making head-to-head or parallel evaluations possible. For small businesses, the program also offers a structured bridge between internal R and D and the broader translational pipeline, connecting companies with experienced preclinical stroke labs and an NIH-supported framework that can strengthen the evidentiary package for future clinical-stage investment and regulatory planning.

Eligibility is limited to small businesses applying under the SBIR framework, consistent with the Phase II SBIR focus. Foreign (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as defined under NIH Grants Policy, may be allowed in some circumstances, which generally means discrete elements of the project could potentially be performed abroad if they meet NIH policy requirements and are well-justified. The administering agency is NIH, the activity category is health, and the CFDA number listed is 93.853. The original closing date in the provided listing was March 14, 2022, and the listed award ceiling is $300,000, reflecting the scale of support indicated in the source data.

Overall, this FOA is best understood as a targeted Phase II SBIR pathway for small businesses that already have a mature, evidence-backed acute cerebroprotective candidate and want that candidate evaluated through a highly coordinated, NINDS-backed preclinical network. The deliverable is not a clinical study, but a stronger, more decision-ready preclinical package that helps determine whether the intervention is truly ready to move toward human trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection- Interventions from Small Businesses (U44 Clinical Trial Not Allowed)" 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 2022-01-06.
• Applicants must submit their applications by 2022-03-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $300,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA NS 22 033

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