Clyra Medical Technologies has accomplished a number of significant achievements in its march toward development of advanced wound care products.
Preliminary formulations of our antimicrobial “hydrogel” and “liquid wound cleanser” products have passed rigorous third party laboratory testing validating both efficacy and safety. Independent testing has verified both rapid and effective control against a host of dangerous pathogens commonly encountered in the wound care field. Testing of Clyra Medical’s liquid formula verified efficacy against antimicrobial resistant species referred to by the CDC as the “ESKAPE” pathogens – enterococcus faecium (VRE), staphylococcus aureus (MRSA), klebsiella species, acinetobacter baumannii, pseudomonas aeruginosa, and enterobacter.
Additionally, Clyra Medical Technologies Inc. has entered into a strategic alliance with a state-of-the-art FDA registered and a current good manufacturing practices (“cGMP”) drug and device manufacturing company located in Florida, which will provide a host of services, including laboratory, regulatory, manufacturing, quality assurance, and supply chain. Formulated Solutions, LLC will help Clyra Medical Technologies Inc. deliver market-ready products that feature our patented technology as soon as possible in the second half of 2013. They will finalize and test product formulations and complete the required data sets required to file the 510(k) premarket notification application with the FDA.
Clyra Medical Technologies wound care applications showcase our mission to ‘make life better’, and should prove out as a highly disruptive technical advancement in this competitive marketplace. We provide a number of solutions to industry wide issues: the need to avoid microbial resistance, a need for gentle but effective ingredients that are readily metabolized by the body, products that can be used across a broad spectrum of pathogens, and cost savings. Clyra Medical Technologies has also initiated discussions to advance our work in the area of biofilm management for chronic wounds, which we began with our technical proof of claims at the University of Hawaii. As a result of our discussions with key opinion leaders from the industry and our meaningful progress, we are excited about the future impact we hope it will have in the industry.