Monday 17 July 2017

BioLargo’s Clyra Medical Subsidiary on Track to File 510K with FDA for Novel Wound Care Products

Tamarack Advisers recently published an article focused on Clyra Medical Technologies' exciting presentation at the Peter Sheehan Wound Healing: Science & Industry Conference in San Juan, Puerto Rico. 


A year and a half ago, BioLargo, Inc. (OTC: BLGO) announced that its Clyra Medical division secured financing to advance its novel wound care products.  Steve Harrison, President of Clyra Medical Technologies, then commented, "We believe this financing will provide the capital needed to help Clyra secure the regulatory approvals and launch what we believe will become a game changer for the Advanced Wound Care industry. This is a fast-growing $8 to $10 billion market in which we believe we will be able to offer better and more cost-effective solutions.”

Last month, Clyra Medical presented their breakthrough products at the 15th annual Peter Sheehan Wound Healing: Science & Industry Conference in Puerto Rico that was attended by leading wound care clinicians and researchers. We had a chance to speak with Mr. Harrison who reported, “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 required pre-submission studies were conducted by Nelson Labs, an independent third party that is recognized as one of the leaders in laboratory testing for FDA submissions.”

The presentation at the conference highlighted Clyra’s advantages over existing wound care products:

  • Clyra’s hydrogel wound dressings and wound wash are highly effective and have no known antimicrobial resistance
  • GLP lab studies demonstrated sustained release and continued antimicrobial effectiveness against major organisms
  • Effective against biofilm in laboratory controlled in vivo pig studies has 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 show 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”

On the flip side of their enthusiasm is that Clyra is keenly aware of the stiff competition they will face in the wound care industry.  One established competitor offering a broad line of wound care products is Smith & Nephew (NYSE: SNN).  Another is Osiris Therapeutics (NASDAQ: OSIR) that offers regenerative medicine products for difficult to treat acute and chronic wounds.

Clyra has retained Emergo, a global firm specializing in medical device regulatory consulting, to prepare its FDA filings, and reports they are on track for filing in the very near future. With the relatively short turnaround times for 510k submissions and the ongoing need for better wound care products, it is possible that Clyra’s powerful, gentle and long-lasting products may soon find themselves entering the rewarding stage of commercialization.

** Corrected Version 7-18-2017

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SOURCE: Tamarack Advisors
For a link to the original article go here!

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