Enabling Technologies to Accelerate Development of Oral Biodevices (R41/R42 Clinical Trial Not Allowed) | PA 19 075

Opportunity Information: Apply for PA 19 075

This NIH small business funding opportunity (PA-19-075) supports early-stage research and development aimed at speeding up the creation and clinical translation of intraoral biodevices, meaning devices that operate in the mouth to sense, measure, diagnose, or potentially help treat health conditions. The focus is on enabling technologies and engineering breakthroughs that solve practical technical barriers that keep promising oral biodevice concepts from becoming safe, reliable, clinically useful products. Rather than incremental tweaks, the FOA is looking for transformative engineering solutions that either create brand-new approaches or substantially optimize existing ones so they are closer to real-world clinical use. The end result NIH expects from funded projects is a proof-of-concept prototype, a dedicated biosensor, or a core platform technology (or integrated system) that clearly demonstrates feasibility for a specific clinical application.

The scientific and technical scope emphasizes integration across electronic, physical, and biological systems, because intraoral devices have to function in a demanding environment: constant moisture, mechanical forces from chewing and speaking, temperature changes, biofilms, and strict safety and biocompatibility constraints. Projects are expected to address the engineering challenges that come with building a functional device that can operate in the oral cavity while producing clinically meaningful data or therapeutic benefit. Examples of the kinds of outcomes envisioned include tools that support precision medicine approaches, such as personalized detection of biomarkers in saliva, monitoring oral or systemic disease indicators, improving diagnosis, guiding treatment decisions, or capturing objective measures of patient functional status and outcomes. The FOA also makes clear that oral biodevices are relevant not only to oral health, but to overall health, reflecting growing interest in saliva and oral measurements as windows into systemic conditions.

The opportunity is designed to push technologies toward clinical readiness, but it explicitly does not allow clinical trials under this announcement. In practice, that means the work should stay on the engineering development and validation side: building and refining prototypes, demonstrating sensor performance, showing analytical validity in relevant settings, testing usability and safety in non-clinical evaluations as appropriate, and generating the kind of data that positions the technology for later-stage clinical testing under a different mechanism. The emphasis on “clinical translation” here is about de-risking and maturing the technology so it can realistically move into clinical evaluation afterward, not running human efficacy studies within this award.

Collaboration is a central theme. NIH is encouraging interdisciplinary teams that combine engineering and device development with expertise in areas like multifunctional sensing, pharmacology, chemistry, medicine, and dentistry. The intent is to ensure that the technology is not only clever on the bench, but aligned with real clinical needs, workflows, and constraints in dental and healthcare settings. The FOA also explicitly encourages partnerships between academia and industry, reflecting the practical reality that device commercialization and deployment typically require both scientific innovation and product development capabilities.

On eligibility, this is an NIH grant mechanism for small businesses (the SBIR/STTR-style R41/R42 pathway), so the primary applicants are small business concerns. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, “foreign components” as defined by NIH policy may be allowed in some cases, which usually means limited, well-justified parts of the project can occur outside the U.S. if they are essential and appropriately documented, but the applicant organization itself must be eligible and based in the U.S.

Key administrative details from the listing include the funding opportunity title “Enabling Technologies to Accelerate Development of Oral Biodevices (R41/R42 Clinical Trial Not Allowed),” opportunity number PA-19-075, agency NIH, and CFDA 93.121. The listing shows an original closing date of 2022-01-05 and does not specify an award ceiling or expected number of awards in the provided excerpt, which typically means applicants need to refer to the full FOA text and NIH budget guidelines for the relevant SBIR/STTR phase to understand typical funding levels and project periods. Overall, the program is aimed at helping small businesses overcome core technical barriers and deliver prototype intraoral biodevice technologies that are positioned for eventual clinical adoption and commercialization, without conducting clinical trials within the award itself.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Enabling Technologies to Accelerate Development of Oral Biodevices (R41/R42 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): 93.121.
• This funding opportunity was created on 2018-11-26.
• Applicants must submit their applications by 2022-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 19 075

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