Co. Moves Step Closer to Getting Products on Market

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BioLargo Inc.'s (BLGO:OTCQX) subsidiary Clyra Medical Technologies Inc. entered into a series of agreements to advance the sales and distribution of its medical products in the U.S. and abroad, it was announced in a news release. Clyra's products are for safely treating wound and skin infections while simultaneously promoting wound healing, thereby reducing the need for antibiotics.

Each of Clyra's new agreements could generate material revenue, though none requires a minimum product purchase.

"These agreements reflect the significant time, energy and resources Clyra has invested to meet client specifications and bring products to market," BioLargo Chief Executive Officer (CEO) Dennis P. Calvert said in the release. "While no prediction can be made as to when the agreements will result in product sales or the volume of sales, we believe each could be important as Clyra grows."

Tackling Infection Control

Tampa, Fla.-based Clyra, BioLargo's 52%-owned subsidiary, develops medical products based on its patented Clyrasept technology involving a copper-iodine complex, according to the company website. A combination of these compounds creates an oxidative reaction that is effective against a wide range of organisms that cause disease, such as viruses, fungi, spores, and even multidrug-resistant bacteria such as Klebsiella pneumoniae. The reaction also is effective against biofilms, bacterial clusters attached to a surface and/or to each other and embedded in a self-produced matrix. The Clyra technology is safe, effective, and biocompatible. It can be delivered in multiple formats, including liquid, dry solution, hydrogel, or embedded in a pad.

Both of Clyra's products, Bioclynse and ViaCLYR, have 510(k) clearance by the U.S. Food and Drug Administration (FDA). Neither is associated with any known acquired microbial resistance.

Bioclynse is a wound irrigation solution used in surgeries and dentistry. ViaCLYR is a long-acting wound irrigation and management solution used for acute and chronic wounds and burns.

Clyra's products can be used by wound care centers, hospitals, nursing homes, urgent care clinics, and home healthcare agencies, in military applications, and by consumers.

Clyra Medical Technologies is a proud member of the BioLargo Family of Companies. BioLargo, according to its website, is a cleantech and life sciences innovator and engineering services solution provider, working to solve some of the world's challenging human health and environmental problems, including infection control, PFAS contamination, and industrial odor/volatile organic compounds control.

Sector to Grow 'Substantially'

The global anti-biofilm wound dressings market is forecasted to see a 9.8% compound annual growth rate (CAGR) between 2025 and 2035, reaching US$2.4 billion in value from US$943.5 million (US$943.5M), according to Future Market Insights. The increasing prevalence of surgical site infection, diabetic ulcers, and chronic wounds is a main growth driver. Biofilms contributing to antibiotic resistance and delayed healing is another.

The market in the U.S. is also set to expand significantly, with a projected 9.3% CAGR during the forecast period. This will be fueled by chronic wounds, an aging population, advanced care demand, technological advancements, and government initiatives.

The Catalyst: Commercial Rollout

Richard Ryan, an analyst at Oak Ridge Financial Research, reported last month that among BioLargo's various solutions to challenging environmental problems, Clyra's Bioclynse was one of two technologies next in line for potential commercialization. BioLargo must get additional products on the market to generate revenue to offset its ongoing, share-diluting cash burn, Ryan implied.

He highlighted that Clyra already had engaged an FDA-compliant manufacturer, Keystone Industries. In March Clyra and its un-named distributor inspected the manufacturer's facilities to ensure production of two Clyra products each could be scaled to 1 million (1M) units.

Subsequently, management indicated the inspection was successful and scaled manufacturing could be ready in the relatively near term. Clyra ordered about US$2M of specialty equipment, and Keystone spent more than US$3M in preparation for commercialization.

"We believe this infrastructure build is for significant anticipated growth," Ryan wrote.

The analyst has a Buy rating on BioLargo and a target price on it implying a 46% return.

Ownership and Share Structure

According to Refinitiv, management and insiders own 14% of BioLargo. The Top 3 are Chief Science Officer Kenneth Code with 8.33%, CEO Dennis Calvert with 3.27% and Director Jack Strommen with 1.62%.

The company's one institutional investor, First American Trust, holds 0.04%. The rest is in retail.

BioLargo has 301.78M outstanding shares and 259.59M free float traded shares. Its market cap is $77.74M. Its 52-week range is $0.16–0.36 per share.