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Hybrid biological systems/biomaterials for in-body sensing


OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Biotechnology The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), 22 CFR Parts 120-130, which controls the export and import of defense-related material and services, including export of sensitive technical data, or the Export Administration Regulation (EAR), 15 CFR Parts 730-774, which controls dual use items. Offerors must disclose any proposed use of foreign nationals (FNs), their country(ies) of origin, the type of visa or work permit possessed, and the statement of work (SOW) tasks intended for accomplishment by the FN(s) in accordance with the Announcement. Offerors are advised foreign nationals proposed to perform on this topic may be restricted due to the technical data under US Export Control Laws. OBJECTIVE: The goal of this topic is the development of “soft” implantable, biocompatible and biodegradable sensors that can measure multiple biomarkers of interest continuously, and provide a signal that can be interrogated either with an external device or internally, as part of the implantable device itself. DESCRIPTION: Implantable sensors are emerging as a promising means to perform a wide variety of diagnostic and therapeutic functions. In these types of applications, the hydrogel-based biocompatible polymer matrix containing photosensitized molecule probes must be properly designed to accurately measure biomarker levels under the skin. The most noticeable example of a flexible micro-sensor was reported by Profusa with Lumee, a tissue implantable device for monitoring the levels of oxygen in the surrounding tissues [1]. Applications of such implantable sensors include monitoring of peripheral artery disease, wound healing, and muscle performance. Recently, implanted sensors were reported for detecting the presence of oral cancers [2], as well as for battery-less recording of deep brain neuropotentials [3]. Research advances in tissue-injectable biopolymer matrix continue to develop for more advanced applications. For example, implantable temperature-sensitive sensors for infection biomarkers such as pH, carbon dioxide and viscosity of synovial fluid were recently developed for early detection of prosthetic joint infections [4]. Overall, with technological advances in biocompatible material development, implantable biosensors will have the potential to improve the management of patient health and quality of life, increasing survival rates while reducing health care costs. To respond to this topic, the performer should design implantable sensors with components that will assemble into soft materials able to interact transiently with analytes of interest and provide a readable signal that allows analytical quantification over time. Soft materials are defined here as made of biological components (proteins, peptides, nucleic acids and the like) in combination with biocompatible and biodegradable polymers that offer an optimal environment for sensing, with no electronics or other hardware required to be implanted. These materials will be in the micro- or nano-size scale in order to be implanted with no compatibility issues and/or major inflammatory reactions. The end deliverable will detect at least two biomarkers of military relevance when implanted in a model system (animal, tissue model, organ-on-chip platform) or in human subjects. The sensors will be active for at least 24 h without any user intervention or regeneration steps to maintain sensor function. PHASE I: The performer should identify/design: i) biological components or systems that can interact with identified biomarkers and produce a readable signal to sense their physiological levels over time, and ii) biopolymers with properties allowing for implantation into soft body tissues. At the end of the Phase I effort, the performer should provide a detailed plan for building the sensor prototype, test it for selectivity, sensitivity and biodegradability and the models/platforms to be used for these tests. The performer should also provide a detailed assessment of the rationale for their design considering inflammatory response, biofluid access, reader function and biodegradability bioproducts toxicity. PHASE II: Multiple biological sensing components or systems should be incorporated into the implantable biopolymer formulation allowing for detection of at least two biomarkers of interest. The performer should investigate cross-reactivity and sensitivity of incorporated sensing components and demonstrate that the implantable biosensor can be used for simultaneous and continuous monitoring of at least two biomarkers of interest. The performer should utilize existing or develop new technologies allowing for the sensor’s signal interrogation either with an external device or internally, as part of the implantable device itself, with no electronics or other hardware required to be implanted. At the end of Phase II, the performer should demonstrate that the implantable sensor can be used for monitoring physiological level of at least two biomarkers of interest and produce signals that can be remotely detected and converted into biomarker quantifying units. PHASE III DUAL USE APPLICATIONS: The performer should test the functionality of the implantable sensor using animal models, tissue models or organ-on-chip platforms. The performer may conduct human studies. At the end of Phase III, the performer should demonstrate that the developed sensing device can be implanted into soft body tissues and can be used for continuous monitoring of at least two biomarkers of interest. The implantable device should be active for at least 24 hours, biocompatible (e.g., without production of toxic or immunological response), and biodegradable over time. The performer should assess marker options for medical use in different areas (tissue regeneration, a self-contained theranostics system, wound healing, etc.) and sports medicine (tissue regeneration/injury recovery, etc.). REFERENCES: 1.; 2. O.K. Hammouda and A.M.M. Allam, “Utilizing implanted antennas to detect the presence of oral cancers,” Res. J. Eng. Scien., vol. 3, pp. 22-27, Jul. 2014.; 3. A. Kiourti, C. Lee, J. Chae, and J.L. Volakis, “A wireless fully-passive neural recording device for unobtrusive neuropotential monitoring,” IEEE Trans. Biomed. Eng., vol. 63, pp. 131-137, Jan. 2016.; 4. Wijayaratna, U. N.; Kiridena, S. D.; Adams, J. D.; Behrend, C. J.; Anker, J. N. “Synovial Fluid PH Sensor for Early Detection of Prosthetic Hip Infections.” Adv. Funct. Mater. 2021, 31 (37), 2104124. KEYWORDS: implantable sensor; biomarkers; biodegradable; continuous sensing
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