First, preliminary
formulations of its 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 the company’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.
Second, it
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 BioLargo deliver market-ready
products that feature the BioLargo’s 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.
Third,
BioLargo changed the name of its medical products subsidiary to Clyra Medical
Technologies, and added former executives from global wound management
companies to its leadership team. Former Smith & Nephew vice president Tanya Rhodes, and BlueSky Medical Group’s co-founder Tim Johnson, joined the
management team. Steven Harrison and Robert Szolomayer of BioLargo have joined
Clyra as president and vice president, respectively. Clyra will produce, market
and distribute medical products featuring BioLargo’s technology.
“Our
wound care applications showcase our mission to ‘make life better’, and should
prove out as a highly disruptive technical advancement in this competitive
marketplace”, stated Dennis Calvert, President & CEO of BioLargo. “The
industry is struggling with a host of issues that we provide a solution to: 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. We also have 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 years ago. As a result of our discussions with key opinion leaders from
the industry and our meaningful progress, we are excited about this venture and
the future impact we hope it will have in the industry and for our shareholders.”
