PROFUSA, INC. — Department of Defense SBIR Phase II: SB12A-003

Description

The overall goal of the Phase II work is to advance novel tissue-integrating lactate sensors towards human testing as rapidly as possible (proposal does not include human testing itself). A single sensor injected subcutaneously can provide months of continuous physiological monitoring data transmitted wirelessly through near-infrared light for remote monitoring. This proposal includes activities such as critically defining specific user requirements for multiple diverse use cases (e.g. trauma, sepsis, exercise physiology/performance optimization, metabolic monitoring, hypoxia studies, skin grafts, wound healing) in order to help focus on greatest-impact use cases and ensure that development meets the end-user needs, accelerating hydrogel formulation iterations, long-term sensor stabilization, recognition element reproducibility, expanding the understanding of lactate kinetics in interstitial fluid, blood transport and metabolism, early and more rigorous biocompatibility testing to ensure safety, particularly centered around biocompatibility and ISO standards, polymer degradation studies, FDA pre-submission meetings, to shape costly ISO hydrogel degradation studies, non-immunogenicity validation, wearability/skin contacting adhesives of the wearable reader, and multiple risk mitigation strategies to ensure adequate accuracy and longevity is obtained in the final sensors.