Sequential Phase II Proposal for Smartphone Application for Mask Sizing and Projecting Quantitative Fit

To address the Chemical and Biological Defense (CBD) need for a field-portable mass spectrometer for small molecule drugs in clinical samples, Physical Optics Corporation (POC) proposes to develop a new FiEldable DRug Mass Analysis (FERMA) system based on a combination of portable mass spectrometry technology with laser desorption/ionization for use with aqueous clinical samples. The FERMA system offers small size, weight, and power (SWaP), field portability, and in vitro operating capabilities for drug analysis. The innovation in using a laser desorption/ionization subsystem for gently generating ion plumes without defragmentation will enable the system to measure drugs (e.g., anesthetics, sedatives, analgesics). The FERMA system renders high precision and accuracy, field portability, and automation without sample preparation. In Phase I, POC will demonstrate the feasibility of FERMA by designing a benchtop prototype and testing certified drug solutions with known concentrations to reach TRL-4. In Phase II, POC plans to develop a fully integrated, portable, ruggedized prototype system for testing and validation in field environments, reaching TRL-6. By the completion of Phase II, we will have a plan for a U.S. FDA presubmission application describing the proposed regulatory approach for FDA clearance, and a mature working prototype that meets all CBD requirements.