PURIOLABS, LLC — Department of Defense SBIR Phase II: DHA213-006

Description

To address the critical challenge explained in SBIR Topic DHA213-006, PURioLABS proposes to deliver Phase II objectives via the PURitALL Desktop Mobile Device Sterilizer, a field-ready, portable sterilization cabinet that will perform the sterilization and drying treatments for surgical scopes and similar sensitive semi-critical or any non-critical medical devices or packaged supplies. In one machine, suspect items, devices and supplies can be chemically sterilized to a high degree of confidence in a process that is so rapid as to be practical and easy. The Phase I completed prototype successfully achieved 0% recoverable bacterial spores in 10 minutes (greater than 6-log reduction) when those spores were located on the distal (furthest) portion of the internal instrument channel of a simulated surgical scope. The technical challenges in delivering the Topic's desired specifications and performance were achieved for Phase I. Further refinements are planned in Phase II work plans including optimized design and treatment cycles as well as all safety and regulatory and GLP studies which will be included in the final FDA 510(k) clearance application. PURioLABS believes the PURitALL Desktop can be field-ready within 24 months. According to the CDC: In the United States, approximately 46.5 million surgical procedures including approximately 5 million gastrointestinal endoscopies—are performed each year. Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes. A major risk of all such procedures is the introduction of pathogens that can lead to infection. Of the approximately two million American patients who acquire an HAI (Healthcare Associated Infection) annually, an estimated 90,000 will die. The average cost of a single case is over $25,000, with the direct cost of HAIs to hospitals estimated at between $28 billion and $45 billion annually. For the warfighter and the supporting forward medical units, lower infection risk equals higher average readiness. For the battlefield and civilian opportunities to lower infection rates, the PURitALL Desktop features an innovative, fast, eco-friendly multi-modal antimicrobial technology that is applied to the exterior surfaces and interior channels of medical devices and supplies. The original core technology has proven efficacy via independent laboratories, is recently deployed as a mobile cabinet in hospital pilots and is acknowledged by leading U.S. epidemiologists as very promising. Our Phase I PURitALL Desktop has further advanced the core technology to provide mobile and rugged sterilization capability with nominal power requirements, a lighter construction, flexible interior space for a variety of devices while not leaving behind harsh chemicals, solid waste or environmental impact. Treated devices are relieved of living bioburden, are dried to touch, have no treatment residue, with no device damage, at a very low cost of operation.