Wednesday, 18 October 2017

BioLargo's Clyra Medical Division 510(k) Application with FDA Offers New Technology for Advanced Wound Care - Tamarack Article

Article By: Tamarack Advisors. 
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The need for effective wound care products has never been greater. Growing global population, rapidly increasing antimicrobial resistance, and the diabetes epidemic among other things, are making it difficult for healthcare providers to effectively treat wounds, putting a strain on patients and also on healthcare systems. Medical professionals are constantly on the lookout for new and innovative methods to help heal difficult-to-treat or chronic wounds, resulting in an $18B market for advanced wound care products.










One such solution is poised to be offered by BioLargo, Inc. (OTC: BLGO) subsidiary, Clyra Medical Technologies. On September 22nd, BioLargo, Inc. (OTC: BLGO)  announced that Clyra submitted an FDA 510(k) application for an advanced wound care product. Clyra has developed a wound care formulation that integrates the well-understood staple of antimicrobial iodine into a revolutionary new product that is more effective yet gentler than current solutions. Additionally, Clyra’s product produces no known antimicrobial resistance and has shown sustained antimicrobial power for up to 3 days.

Iodine has been the considered a gold standard antimicrobial for nearly two hundred years. However, traditional iodine products contain high, toxic levels of iodine, which can be damaging to fibroblasts and delay wound healing. Consequently, physicians consider traditional iodine products as a “last resort,” preferring gentler antimicrobial treatments for managing chronic wounds, such as silver, honey, and hypochlorous acid. While these antimicrobials have various proven levels of efficacy, in each case they present some sort of tradeoff in practical use, such as high costs, potential for acquired resistance, cytotoxic implications (damage to skin or other cells), and a limited effective duration.   

A wound care antimicrobial formulated with high efficacy and without the tradeoffs of the most-often prescribed products on the market would be poised to disrupt the advanced wound care industry. That’s exactly what BioLargo’s Clyra Medical Technologies has done. Their product is broad-spectrum, highly effective, and doesn’t have the collateral tissue damage problems of previous iodine-based wound care products. It remains effective longer than traditional antimicrobials, has no-know microbial resistance, and with such a low level of iodine can be offered at lower costs. The Clyra product creates a wound environment that is much more amenable to healing and regeneration. Consequently, Clyra’s wound care product has the potential to provide immense benefit in innumerable chronic or difficult-to-treat wound situations, and Clyra anticipates having a big impact on the very competitive $18B advanced wound care market.

Clyra management reports that after years of development work, they have developed a proprietary technology that retains the full power of iodine, yet minimizes skin tissue damage so that the products can remain non-cytotoxic. While Clyra’s products will likely feature additional technical claims, features and benefits, its broad spectrum and sustained antimicrobial performance (including biofilm), coupled with its safety profile and low cost, distinguish it from alternative products.

In June, Clyra presented their breakthrough technology at the 15th annual Peter Sheehan Wound Healing: Science & Industry Conference in Puerto Rico, attended by leading wound care clinicians and researchers. We had a chance to speak with Clyra Medical President, Steve Harrison, about the new technology. He commented, "We are highly encouraged by the overwhelming positive response from the clinical wound care experts attending the conference. The data from the FDA pre-submission testing generated a great deal of enthusiasm among the leading clinicians and researchers at the conference.”

The presentation at the conference highlighted Clyra's advantages over existing wound care products:
  • Clyra's hydrogel wound dressings are highly effective and have no known microbial resistance.
  • GLP lab studies demonstrated sustained release and continued antimicrobial effectiveness against major organisms.
  • In vivo pig studies have shown effectiveness against mature biofilm, with better results than certain prescription antimicrobial solutions.
  • Non-cytotoxic, non-sensitizing, and safe to human cells.
  • Can easily integrate Clyra technologies into existing products and new ones in the pipeline, including regenerative tissue.

Dr. Brock Liden, DPM, a wound care expert with an extensive wound and limb salvage practice in Ohio, presented the latest Clyra data to the conference. He commented, "When I was introduced to the Clyra technology, I was very interested to learn more. This is a complex that has been shown to impact bacteria, and shows sustained activity, yet be safe to cells and the wound healing process. It may have clinical application to be used with cellular tissue products, stem cells, and growth factors with no harm to the modality. This is a significant breakthrough in the wound space. With further clinical research we may even have a modality to impact established biofilms while doing no harm to the host or the healing modalities being utilized. As I learn more about Clyra's technology, I feel that it has the potential to have a significant impact in wound care, as well as potential in other areas of medicine."

Mr. Harrison continued, “In keeping with BioLargo’s mission, our advanced wound care products have an important contribution to Make Life Better as we compete for a segment of the $18 billion global advanced wound care market. Our products are safe, gentle, and effective, and as such, we believe their role in infection control, chronic wound management and regenerative skin therapy are important and valuable. We are targeting early 2018 to be ready for market.”
Clyra is keenly aware of the competition they will face in the wound care industry.  One established competitor offering a broad line of antimicrobial wound care products including silver and iodine based offerings is Smith & Nephew (NYSE: SNN). Another competitor is Derma Sciences (honey), now owned by Integra LifeSciences Holdings Company (NASDAQ: IART). Senior Strategy Advisor to Clyra Medical, Tanya Rhodes, Ph.D., was the former Smith & Nephew Vice President of Innovation and Vice President at Smith & Nephew Wound Management. Dr. Rhodes invested 15 years at Smith & Nephew U.S., and more than 20 years in the wound management and skin care industry globally. She has established a broad base of expertise that includes a concept-to-commercialization philosophy utilizing product design, strategic marketing and evidence-based trials as well as reimbursement and regulatory compliance strategies. Over her career, she played an instrumental role in bringing a number of staple wound care technologies to market around the globe.
Management tells us that several additional products are in the pipeline and expected to follow.  Clyra’s wound care products’ data will also be presented at the upcoming SAWC (Symposium on Advanced Wound Care) fall meeting held in Las Vegas on October 20-22, 2017.
















About BioLargo, Inc.
BioLargo, Inc. is a sustainable science and technology company that makes life better by delivering award-winning products for clean water, clean air and advanced wound care. More information can be found about the company and its subsidiaries at www.BioLargo.com. Its subsidiary BioLargo Water, Inc. (www.BioLargoWater.com) showcases its emerging technology, the Advanced Oxidation System “AOS”, an award-winning product, having been awarded more than 35 research grants and counting, specifically designed to eliminate common, troublesome, and dangerous (toxic) contaminants in water in a fraction of the time and cost of current technologies. BioLargo's subsidiary Odor-No-More Inc., features sustainable odor elimination products including its CupriDyne Clean (www.CupriDyne.com) Industrial Odor Eliminator, a product currently serving the leading solid waste handling and wastewater treatment companies as well as any industry that must contend with malodors, VOC’s or similar air quality related problems. Its personal care products are finding adoption through white labeling or early market entry in the pet, equine, military supply and consumer markets, and include the Nature's Best Solution® and Deodorall® brands (www.OdorNoMore.com). BioLargo's subsidiary Clyra Medical Technologies, Inc. (www.ClyraMedical.com) focuses on advanced wound care management featuring effective and gentle solutions for chronic infected wounds and other uses to promote infection control. BioLargo also owns a 50% interest in the Isan System, a fully automated iodine dosing system being commercialized under a license to Clarion Water, Inc.
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