NIH Highlighted Topic: Microphysiological System Pilot Studies in Diabetes Research
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is encouraging collaborative research that applies human microphysiological systems (MPSs), often called organ-on-chip or tissue-chip platforms, to cell and tissue types relevant to diabetes and its kidney and urologic complications. MPSs are a New Approach Methodology (NAM) that support long-term culture of human cells under physiologically relevant conditions, enable real-time observation, biosensing, and frequent sampling, and can connect multiple tissue or organ models.
A central goal is pairing engineering and device developers with biology and physiology researchers so MPSs can be more widely adopted in diabetes research. High-priority areas include systems with at least two diabetes-relevant human tissues that demonstrate stability and durability, validation of diabetes pathophysiology through biosensors and multiplexed monitoring, studies of crosstalk between tissues, models with mature cell types and interacting compartments such as vasculature, nerves, and stroma, disease phenotypes created through gene editing or environmental perturbation, and multi-tissue models of diabetic kidney disease and urologic complications.
Relevant tissues include pancreatic islets, liver, adipose tissue, gut, vasculature, and skeletal muscle. The topic is part of the NIH MAHA Chronic Disease Initiative and NIH's broader push for NAMs, which NIH, FDA, and EPA have all committed to using where appropriate.
How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. NIDDK asks that responsive projects be tightly focused and short in duration (1 to 3 years) to establish proof of concept and demonstrate feasibility, which fits naturally with a focused SBIR Phase I scope. STTR is a strong option for company and university engineering partnerships. We also recommend contacting the listed NIDDK scientific contacts to confirm fit before writing.
This highlighted topic is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NIDDK notes it may dedicate funds to this area, depending on availability and the number of meritorious applications, and may give special consideration to meritorious applications. The topic is active from September 10, 2026 through September 10, 2028.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of microphysiological systems, biosensors, and enabling tools for diabetes research.
Eligible activities may include:
Multi-tissue MPS platforms incorporating two or more diabetes-relevant human tissues
Integrated biosensors and multiplexed sampling for real-time metabolic readouts
Vascularized or innervated tissue models built with mature human cell types
Disease-phenotype models created through gene editing or environmental perturbation
Models of diabetic kidney disease and urologic complications
Standardization, reproducibility, and validation studies against human data
Commercialization planning and market validation with pharma and research end users
Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable microphysiological system product aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until September 10, 2028. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have 500 or fewer employees including affiliates.
Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.