BioLargo Achieves Breakout Milestones in Advanced Wound Care on Track for FDA 510(k) Submission and Commercialization
BioLargo, Inc. (OTCBB: BLGO) announced today that it 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."
About BioLargo, Inc.
BioLargo's business strategy is to harness and deliver Nature's Best Solution® -- free-iodine -- in a safe, efficient, environmentally sensitive and cost-effective manner. Its proprietary technology works by combining micro-nutrient salts with liquid from any source to deliver free-iodine on demand, in controlled dosages, in order to balance efficacy of performance with concerns about toxicity. The technology has potential commercial applications within global industries, including but not limited to oil and gas, animal health, beach and soil environmental uses, consumer products, agriculture, food processing, medical, and water. It features solutions for odor & moisture control, disinfection and contaminated water treatment. The company's goal is to improve the quality of life for people worldwide, while it protects the environment, and produces positive economic results for our customers, partners, and shareholders. Its website is www.BioLargo.com. The company's Odor-No-More® product was awarded two Editor's Choice Awards, including a "Product of the Year" award, by the Horse Journal, a top industry publication, as well as a Best New Product SuperZoo Award, and are sold by BioLargo's wholly owned subsidiary, Odor-No-More, Inc. (www.OdorNoMore.com). BioLargo also owns a 50% interest in the Isan System, already commercialized in Australia, which was honored with a "Top 50 Water Company for the 21st Century" award by the Artemis Project. It operates a wholly owned subsidiary named Clyra Medical Technologies focused on advanced wound care management that is preparing to make FDA 510(k) applications in 2013.
Safe Harbor Statement
The statements contained herein, which are not historical, are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, including, but not limited to, the risks and uncertainties included in BioLargo's current and future filings with the Securities and Exchange Commission, including those set forth in BioLargo's Annual Report on Form 10-K for the year ended December 31, 2011.