Update on The Rapid Blood Ammonia Testing Instrument

​Thomas Veltman, Ph.D.
President and CTO
Aza Technology, Inc.

Aza Technology has made significant progress towards the commercialization of our point-of-care Ammonia Monitoring Device (AMD).  In our previous update, we informed readers that we had achieved Breakthrough status with FDA and begun the transition to quality management system with KMC Systems, our manufacturing partner.  Since that time, we have been able to complete our clinical trial plan pre-sub with FDA, received feedback and we are in discussions with the FDA. Additionally, we were awarded an SBIR grant from NIH which enabled us to build equipment for preparing our proprietary coated paper, which is the heart of our consumable ammonia cartridge.  This system is presently capable of producing material for 2 million cartridges per year, and can be expanded in the future to meet extra demand.  We have also commissioned our production-grade molds for injection molding of our cartridge parts, enabling manufacturing at scale.  We have fully transferred the design and specifications for the AMD to KMC Systems, and have fully integrated the AMD into their Quality Management System.  This has allowed us to set the stage for pilot-scale manufacturing for the planned FDA clinical trials, and will enable full-scale manufacturing following our 510(k) FDA clearance.  We are currently raising a round of funding to develop our pilot manufacturing line at KMC and to hire a CRO (Clinical Research Organization) to complete the FDA clinical studies.  Upon securing this funding, we will push forward with these plans.

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