CleanTech Company Advances FDA-Cleared Solution Toward Big Gains

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1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

Clean technology and life sciences company BioLargo Inc. (BLGO:OTCQX) announced that its subsidiary, Clyra Medical Technologies, Inc., has received its first commercial stocking order from Advanced Solution LLC for ViaCLYR™, Clyra's FDA-cleared wound irrigation solution, according to a February 9 release.

This order marks the beginning of commercial distribution and signifies Clyra's shift from development-stage operations to generating early revenue. The stocking order enables product availability through Advanced Solution's national distribution network, facilitating sales to hospitals, clinics, and healthcare providers across the United States.

BioLargo sees this milestone as the first in a series of planned commercial and revenue-related announcements as Clyra progresses its market rollout.

"This initial commercial order reflects years of disciplined development, regulatory execution, and commercial preparation," said Steve Harrison, Clyra's chief executive officer. "With ViaCLYR™ now entering the distribution channel, we are beginning the transition from innovation to execution, laying the groundwork for scalable revenue growth as adoption expands."

ViaCLYR™ is a highly effective, tissue-safe, long-acting wound irrigation solution suitable for acute and chronic wounds and burns. This unique, clear, odorless, non-irritating solution is 510(k) cleared by the FDA and indicated for acute and chronic wounds. It boasts extremely high antimicrobial activity as a preservative in solution, with over 99.9999% kill rate (up to 7 log reduction) and sustained efficacy for up to 72 hours, the company said.

Dennis P. Calvert, chairman of Clyra Medical Technologies and president and CEO of BioLargo, added, "This milestone represents a tangible step forward in BioLargo's strategy of developing differentiated technologies and advancing them into commercial markets through strong partnerships. We believe Clyra is well positioned to build momentum as product availability expands and market awareness grows."

Clyra's commercial readiness reflects the completion of key foundational elements, including FDA 510(k) clearance, implementation of ISO 13485-certified quality systems, validated manufacturing processes, and clinical evaluations supporting real-world use, BioLargo noted. As distribution begins, Clyra plans to advance additional commercialization initiatives and expand its product portfolio over time.

Clyra is a partially owned subsidiary of BioLargo that focuses on infection control and advanced wound care. Founded in 2012, the company develops and commercializes wound care solutions based on its proprietary Copper-Iodine Complex Technology. Clyra's product portfolio features FDA-cleared medical devices that leverage this patented technology to deliver superior wound care outcomes.

Co. Makes Progress on Multiple Platforms in 2025

At the end of 2025, Calvert shared an open letter with shareholders reflecting on the year and looking ahead to the company's role in "what may be one of the largest infrastructure and technology investment cycles in history."

"Global investment trends driven by artificial intelligence, data centers, electrification, energy storage, and environmental remediation are placing increasing demands on water systems, energy infrastructure, and regulatory compliance," Calvert noted. "BioLargo's portfolio of enabling technologies has been developed to address these challenges at the system level, where performance, sustainability, and economics increasingly converge."

BioLargo said it views Clyra as operating precisely at this type of intersection, where regulatory rigor, performance requirements, and sustainability pressures converge in healthcare and life-science environments.

Throughout 2025, BioLargo made progress on multiple technology platforms through ongoing development, validation, and initial deployment efforts, Calvert noted. Management deliberately prioritized strategic advancement over rapid expansion, understanding that growth is most effective when supported by a solid technical and commercial foundation. This focus on capital efficiency and technical precision is intended to facilitate faster, lower-risk scaling as market adoption grows.

"This approach reflects BioLargo's long-standing strategy to develop high-impact technologies patiently, validate them thoroughly, and position them to serve large and growing markets where demand is driven by structural forces rather than short-term trends," Calvert said.

In 2025, BioLargo advanced several projects in New Jersey that demonstrate the company's shift from development to real-world application, according to the letter. These projects include the installation of the company's proprietary Aqueous Electrostatic Concentrator (AEC) at a municipal water treatment facility in Lake Stockholm, New Jersey. The AEC offers rapid, effective, and affordable concentration and removal of per- and polyfluoroalkyl substances (PFAS) from water.

In addition, to the Clyra advancements, the company said it is also working to formalize a budding public-private partnership that could lead to the construction and operation of one or more Cellinity battery factories aligned with state and regional infrastructure priorities, the letter said.

"While these initiatives remain subject to further development and execution, they represent tangible progress toward deployment and reflect growing institutional engagement with BioLargo's technologies," Calvert wrote. "It is also worth noting that BioLargo's engineering team has a long and successful history of working with industry and governments in the State of New Jersey."

Narrowing the 'Valuation Gap'

During an online discussion with Calvert and Harrison on November 20, 2025, Chris Temple from The National Investor shared his insights on the company following a recent announcement about the AEC's performance. He stated, "BioLargo announced that its regimen to remove PFAS 'forever chemicals' from water is even more robust."

In a January 30 update, Temple said he is confident the AEC system "will lead to an explosion of business for the company to follow."

BioLargo made significant progress in several project initiatives in 2025, "reflecting the company's shift from development to real-world application," according to Richard Ryan, an analyst at Oak Ridge Financial, in a research note dated January 5. Ryan rated the stock a Buy.

Looking ahead to this year, BioLargo anticipates achieving validation of its technologies and Clyra's products, along with significant revenue from Clyra. According to Oak Ridge, in 2026, BioLargo and other small-cap stocks "may begin to reap the benefits of enhanced productivity from the AI trade and a sustained monetary easing cycle, thus narrowing the growing valuation gap."

The Catalyst: Increasing Prevalence of Chronic Diseases

According to Future Market Insights, the global market for anti-biofilm wound dressings is expected to grow at a compound annual growth rate (CAGR) of 9.8% from 2025 to 2035, increasing from US$943.5 million to US$2.4 billion. This growth is largely driven by the rising incidence of surgical site infections, diabetic ulcers, and chronic wounds.

Biofilms, which contribute to antibiotic resistance and slow healing, are also a significant factor. In the U.S., the market is projected to expand significantly, with a forecasted CAGR of 9.3% over the period. This growth is supported by the prevalence of chronic wounds, an aging population, the demand for advanced care, technological advancements, and government initiatives, according to the research firm.

Fact.MR, a global provider of data-driven market intelligence, noted that "The global wound irrigation solution market is evaluated at a size of US$732 million in 2024 and has been forecasted to expand at a CAGR of 3.4% to reach US$1.02 billion by the end of 2034." The increasing prevalence of chronic diseases such as diabetes and vascular conditions is driving the demand for wound care solutions. Hospitals and clinics are increasingly adopting wound irrigation protocols to prevent surgical site infections.

According to the National Institutes of Health, about 99,000 deaths are associated with healthcare-associated infections (HAIs) each year. On any given day, approximately 1 in 31 hospital patients has at least one HAI. These infections are a serious concern, leading to millions of infections and significant costs for the healthcare system.

Ownership and Share Structure¹

About 13.85% of BioLargo is owned by insiders and management. They include Chief Science Officer Kenneth Code with 8.18%, CEO Calvert with 3.34%, and Director Jack Strommen with 1.56%.

About 0.04% is held by the institution First American Trust. The rest, 86%, is retail.

Its market cap is US$56.19 million, with about 313.76 million shares outstanding and about 266.36 million free-floating. It trades in a 52-week range of US$0.30 and US$0.14.