PURitALL Sterilizer - Sequential Phase II

Hospital acquired infections (HAI) present a significant problem for both commercial and military hospital environments. Of the approximately 46.5 million surgical procedures in the USA, 2 million patients acquire an HAI resulting in an estimated cost to hospitals between $28 billion and $45 billion. For the warfighter and the supporting forward medical units, infections present a significant risk to unit readiness. PURitALL Sterilizer can deliver a modern solution to lower warfighter infection risk.  To address the critical challenge explained in SBIR Topic DHA213-006, PURioLABS proposes to deliver Sequential Phase II results via the PURitALL Sterilizer, a field-ready, portable sterilization cabinet that will perform the sterilization and drying treatments for surgical scopes and other critical or semi-critical or non-critical medical devices. In one machine, medical items can be terminally sterilized in a process that is rapid, practical, and easy. The PURitALL core technology has proven its efficacy via independent laboratories and was deployed as a mobile cabinet in hospital pilots during COVID-19 crisis in 2020 and 2021. This initial pilot was acknowledged by leading U.S. epidemiologists for its promise. Subsequently, the Phase I completed prototype successfully fulfilled the topic’s technical challenges by achieving greater than 6-log reduction in recoverable bacterial spores in 10 minutes on a simulated endoscope with spores inoculated in the hardest to reach channel location. Phase II then sought to refine the sterilizer design to better fulfill DHA and commercial stakeholder interests as well as reduce regulatory risk. In an effort to better understand the PURitALL supercharging phenomenon, the PURioLABS team created more sophisticated test methods that expanded the breadth of scientific research capability for this next-generation device. As a result, the team discovered methods to significantly increase the treatment cycle speed while presenting less of a risk to the instrument and increasing sterilizer design flexibility. Phase II also included a full regulatory review of all needed validation and verification efforts  and accomplished three FDA pre-submission meetings, resulting in a mutual expectation of the contents of our formal FDA 510(k) clearance application. Most importantly, the key variables for optimal efficacy are known as a result of Phase II research and internal experimentation which once again validated Phase 1 results. The Sequential Phase II effort will begin with microbiological studies to verify the critical ROS Supercharging variables identified in Phase II. The final design of a portable sterilization cabinet will be determined from these studies and will result in a newer, rugged, commercial-quality PURitALL Sterilizer built to undergo all safety and regulatory testing required for FDA 510(k) clearance. PURioLABS believes a commercially demonstrable PURitALL Sterilizer can be field-ready within 24 months.