Key Dates

Related Announcements

• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-23-230.
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232.
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See NOFO PA-23-231.
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). See NOFO PA-23-233. 

Issued by

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Dental and Craniofacial Research (NIDCR)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to invite NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applications focused on advancing paradigm-shifting biomaterials-based technologies leading to commercialized products.   Additionally, this NOSI aims to generate private-sector interest and engagement in the development of innovative and emerging biomaterials-based technologies of biomedical and clinical relevance with high commercialization potential. 

Background: 

A biomaterial is any matter, surface, or construct that interacts with biological systems. Biomaterials can be derived from nature or synthesized in the laboratory using metallic components, polymers, ceramics, or composite materials. In 2021, the global biomaterials market size was estimated to be $135.4 billion and projected to grow at a rate of 15.4% during the next decade.  However, the translation of early-stage biomaterials-based technologies to clinically relevant, commercially viable biomedical products is notoriously challenging, with small businesses being limited in the ability to capitalize on the market potential of platform technology development. Additionally, the lack of tools and standards to determine the safety and effectiveness of novel biomaterials presents unique regulatory challenges for innovators in this space (Song et al., 2021). Therefore, a gap remains between the translation of laboratory-based discoveries to commercially and clinically successful biomaterials-based technologies. This SBIR/STTR initiative, paired with product development resources from the NIBIB biomaterials network, will bridge some of these gaps and accelerate the development of critically needed biomaterials. 

Research Objectives:

The National Institute of Biomedical Imaging and Bioengineering (NIBIB): 

The mission of the NIBIB is to transform through engineering the understanding of disease and its prevention, detection, diagnosis, and treatment. As it relates to this NOSI, the NIBIB aims to encourage small business interest in developing broadly applicable platform technologies that can be optimized for success in a variety of biomedical products and clinical applications.

Examples of projects responsive to this NOSI within the NIBIB’s mission include, but are not limited to:

• Development of novel classes of materials with biomedical applications (e.g., active materials, bio-integrating and bio-inspired materials, novel material architectures and/or manufacturing methods).
• Development of biomaterials to construct or coat implantable devices aimed at improving biocompatibility, performance, safety, longevity, or other properties limited by current material application.
• Formulation of new contrast agents or probes for use in biomedical imaging applications.
• Early-stage engineering and development of bio-integrating materials, such as materials with tailored immunomodulation properties, personalized materials, rapid assays and sensors.
• Re-engineering of specialized biomaterials-based technologies towards more broadly applicable functionality.
• Development of innovative methods or techniques to address challenges in scaling biomaterials-based technologies to clinical translation (e.g., large-scale manufacturing, characterization techniques, machine learning/artificial intelligence, etc.).

The National Heart Lung and Blood Institute (NHLBI):

The NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, blood, and sleep (HLBS) diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI invites projects developing new biomaterials with high commercialization potential, proof of concept applications of existing biomaterials, and in vivo validation of more mature biomaterial technologies for HLBS diseases or conditions. Fast-Track and Phase II applications should include a regulatory plan if applicable to the proposed product commercialization in the Commercialization Plan document.  Examples of topics of interest within the scope of this NOSI include but are not limited to:

• AI- mediated design and manufacturing of biomaterials for HLBS-specific indications
• Tissue organoids, Organ-on-a-chip systems, and in vitro models for the screening/identification of novel therapeutics and diagnostics for HLBS diseases
• Immunomodulatory biomaterials to facilitate tissue repair and regeneration in HLBS diseases
• Integration of nanotechnology for targeted drug delivery to treat HLBS diseases
• Creating biomaterial environments optimized for the growth, differentiation, and delivery of stem cells for HLBS therapies
• Development of biomaterials (or coatings) that are optimized for long-term use in wearable devices or implants for monitoring or treating HLBS disorders without inflicting an adverse immune response or inflammation
• Development of biomedical products that can be used to improve sleep disorders, such as sleep apnea
• Design of novel, portable biomedical products for draining, posttraumatic, and post-surgical empyema as well as for discharging pleural effusions
• Novel biomaterial-based sensors that provide a readout of normal or disease-affected physiological states
• Design of materials that prevent blood clotting, which can be used in various medical devices like catheters or stents
• Biomaterials designed to enhance vascularization of tissues for HLBS conditions
• New biomaterials that may be used to replace or supplement whole blood or blood products for transfusion medicine

The National Center for Advancing Translational Sciences (NCATS):

NCATS conducts and supports research and other activities that address long-standing challenges in the translational research pipeline to provide more treatments to more people more quickly. In this NOSI, NCATS is interested in novel biomaterials for diagnostics, therapeutics, medical procedures and potentially, behavioral changes. We are interested in cutting-edge application of biomaterials that can go through the rigors of validation, benchmarking and standardization. Specifically, we are looking for:

• Biomaterials for drug delivery for controlled release of small and macromolecule drugs such as peptides, polymer nanoparticles, hydrogels, etc.
• Bioresponsive polymers for the release of drugs at the desired target through chemical, physical and biological stimuli.
• Biomaterials for wearable diagnostics and biosensors that are flexible and conformable aimed at skin volatile organic compounds and sweat biomarkers. These wearables can be “self-powered” by fuel cells such as piezoelectric energy harvesters or energy generators from the body’s own glucose.
• Theranostic (dual therapeutic and diagnostic) biomaterials such as tissue-specific probes that can be triggered by light, vibration, magnetism, etc. to target diseased tissue. Included here are multimodal theranostic particles conjugated with both drugs and diagnostic probes that can be imaged with technologies such as NIR, photoacoustics, fluorescence, etc.
• Novel tunable, biocompatible hydrogels and scaffolding for tissue chips and 3-D bioprinting.
• “Green” biopolymers that are biodegradable, re-usable and recyclable. These include high efficiency, low turnover biomaterials produced with minimal energy consumption, as well as metamaterials with multiple applications during their life cycle.

The National Institute of Dental and Craniofacial Research (NIDCR):

The NIDCR is interested in applications that are relevant to the NIDCR mission and strategic plan.  Potential areas of NIDCR interest for highly impactful translational research in the development of innovative and emerging biomaterials-based technologies of clinical relevance in dental, oral, and craniofacial (DOC) biomaterials.  Examples of topics of interest within the scope of this NOSI include but are not limited to:

• Develop novel bonding technologies with enhanced durability and longevity, addressing challenges related to bonding layer degradation over time.
• Leverage the influence of biological factors on material degradation and develop bioactive materials that interact favorably with the oral environment to promote tissue regeneration.
• Integrate the use of clinical data registries to collect real-world evidence on the performance of restorative materials, leveraging big data analytics to enhance data-driven discovery and build confidence in new technologies.
• Develop predictive models and early-stage biocompatibility testing methods to guide the development of biologically relevant materials and minimize the risk of adverse reactions.
• Improve fabrication workflows through data-led strategies and optimize materials for 3D printing and other digital fabrication technologies to enhance performance and efficiency.
• Develop predictive models and assessment tools for various aspects of biomaterial performance, including substance elution, antimicrobial activity, durability, and biocompatibility, to streamline preclinical development and regulatory approval processes.
• Develop interventions within reasonable timeframes utilizing remineralizing peptides and systems, along with technologies for increased penetration depth, such as electrophoretic migration.
• Develop diagnostic tools with improved sensitivity and specificity considering a multi-parametric approach to address patient-specific needs.
• Develop affordable over-the-counter homecare products for early caries lesions, explore interventions targeting early stages of caries, and advance technologies for imaging and analyzing enamel structure in situ.
• Develop methods and strategies to increase mechanical and physical properties of newly remineralized tissues such that they recapitulate native values. 

The National Center for Complementary and Integrative Health (NCCIH):

The NCCIH will support applications on the development of biomaterials-based technologies and therapies relevant to complimentary and integrative approaches. Complementary health approaches include a broad range of practices and interventions that are not typically part of conventional medical care and can be classified by their primary therapeutic input, including nutritional (e.g., botanicals, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, dance therapies, or some forms of art therapies, such as music-based interventions) input.

Examples of such biomaterials-based technologies include, but are not limited to:

• Development of biomaterials for oral delivery of microbial-based therapies to enhance their clinical outcomes.  This may include technologies that protect live microbial strains from the gastrointestinal (GI) environment, release in a spatially controlled manner, and enhance their retention in the GI tract.
• Development of biomaterials for oral or transdermal delivery of small molecule natural product therapies to enhance their clinical outcomes.  This may include technologies that improve natural product stability, targeted delivery, and bioavailability.
• Development of tissue organoids, organ-on-chip models, and hydrogels for the screening/identification of novel natural product therapies and spatial mapping of the effects of natural product therapeutics.
• The development of bio-material based wearable biosensors to readout the whole-body physiological states with the integration of complementary and integrative interventions.

Application and Submission Information:

• Applications for this initiative must be submitted using the following opportunities or their subsequent reissued equivalents:
  • July 12, 2023 – PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See PA-23-230
  • July 12, 2023 – PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See PA-23-231 
  • July 12, 2023 –  PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See PA-23-232
  • July 12, 2023 – PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). See PA-23-233
• This notice applies to due dates on or after September 5, 2024 through April 5, 2027.
• All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:
  • For funding consideration, applicants must include “NOT-EB-24-001” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form.
  • Application without this information in box 4B will not be considered for this initiative.
  • Applicants may be given the opportunity to interact with and take advantage of the Biomaterials Network groups and resources. For more information, please contact Dr. Luisa Russell (Luisa.Russell@nih.gov).
• Applicants are strongly encouraged to consider entrepreneurial training programs, such as Concept to Clinic: Commercializing Innovation (C3i), or I-Corps at NIH, when feasible.
  • The NIH C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). There are two components of this program: the Educational component (eC3i) is a 10-week virtual program largely focused on understanding market need and value propositions. The Validation/Execution component(C3i) is a 24-week in-depth course that provides commercialization planning support, covering topics such as intellectual property strategy, regulatory and reimbursement requirements, risk assessment, milestone creation and valuation, and preparations for pitching to investors and/or strategic partners.
  • I-Corps at NIH is an entrepreneurship training program specifically designed for companies to learn how to focus their business plan and get the tools to bring their treatment to the patients who need it most.
• Applicants should also consider taking advantage of other resources offered by the NIH, such as:
  • Technical and Business Assistance (TABA) Funding
  • Regulatory and Business Development Consultations
  • Partnering and Investment Opportunities; and
  • Other IC-specific commercialization resources

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

NIBIB:

Kari Ashmont, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB) Small Business Program
Email: NIBIB-SBIR@mail.nih.gov

Luisa M. Russell, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-5654
Email: luisa.russell@nih.gov 

NHLBI:

Stephanie M. Davis, PhD
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: (301) 496-8412
E-mail: stephanie.davis3@nih.gov

NCATS:

Leah Croucher, Ph.D.
National Center for Advancing Translational Science (NCATS)
Telephone: 301-827-7149
Email: leah.croucher@nih.gov

NIDCR:

Orlando Lopez, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 240-701-2580
E-mail: orlando.lopez@nih.gov

Jason Wan, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 594-9898
E-mail: jasonwan@mail.nih.gov

NCCIH:

Emrin Horgusluoglu, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 240-383-5302
Email: emrin.horgusluoglu-moloch@nih.gov 

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB) Grants Management
Telephone: 301-451-4786
Email: james.huff@nih.gov