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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