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

DENVER, CO / ACCESSWIRE / July 17, 2017 / A year and a half ago, BioLargo, Inc. (OTCQB: 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 overwhelmingly 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 of up to 30 days compared to 3-minute half-life for the best current solutions.
Effective against biofilm in laboratory controlled in vitro studies.
Non-cytotoxic, non-sensitive, and safe to human cells.
Can easily integrate Clyra technologies into existing products and new ones on the drawing board.

Dr. Brock Liden, DPM, a wound care expert with an extensive wound and limb salvage practice in Ohio, presented the Clyra products to the conference. He commented, “When I was introduced to the Clyra technology, I was very interested in learning 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, 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 (SNN). Another is Osiris Therapeutics (OSIR), which 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.

Legal Disclaimer:

Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Flathead Business Solutions LLC, which owns tamarackadvisorsinc.com, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. Flathead Business Solutions LLC may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. Flathead Business Solutions LLC may be compensated for its services in the form of cash-based compensation or equity securities in the companies it writes about, or a combination of the two. For full disclosure please visit http://tamarackadvisorsinc.com/legal-disclaimer/.

SOURCE: Tamarack Advisors

ReleaseID: 468410