Tuesday, 18 December 2012

BioLargo Achieves Breakout Milestones in Advanced Wound Care on Track for FDA 510(k) Submission and Commercialization

LA MIRADA, Calif. - BioLargo, Inc. announced (12-17-2012) that had accomplished a number of significant achievements in its march toward commercialization of advanced wound care products featuring its patented BioLargo technology.

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.”