BioLargo Subsidiary Clyra Medical Accelerates Toward Near-Term Product Launches and Global Expansion

Rhea-AI Summary

BioLargo (OTCQX:BLGO) announced that its subsidiary Clyra Medical is advancing toward commercial launches and international expansion for its ViaCLYR wound irrigation and surgical products, targeting initial U.S. and select EMEA sales in late 2025 or early 2026. Key activities include distributor agreements for EMEA and U.S. reach, completion of package and label design, product claim finalization, and ongoing stability, packaging and process validation ahead of standard FDA submission and review. Clyra has secured $7.5 million in capital to support manufacturing readiness and rollouts. Market context cites a $732 million 2024 wound irrigation market with 3.4% CAGR to 2034.

Positive

• $7.5M capital secured in past 12 months
• Targeting commercial launch in late 2025 or early 2026
• Distribution agreements covering EMEA and U.S.
• Planned U.S. availability to > 6,000 hospitals

Negative

• EMEA sales limited until CE Mark secured
• Commercial launch subject to FDA submission and review

Initial Commercialization Targeting $732 Million Wound Care Market is Expected in Late 2025 or Early 2026

WESTMINSTER, CALIFORNIA / ACCESS Newswire / October 13, 2025 / BioLargo, Inc. (OTCQX:BLGO), a cleantech innovator that creates and commercializes sustainable technologies, today announced that its subsidiary Clyra Medical Technologies has achieved noteworthy progress across product development, commercialization, and clinical programs, advancing toward multiple near-term market launches and international expansion.

ViaCLYR: Market Launch on Track

Clyra's ViaCLYR, an advanced wound irrigation and antimicrobial solution, remains on schedule for commercial launch in late 2025 or early 2026 through multiple established distributors with domestic and international reach. The company is also expanding collaborations with clinicians to conduct targeted evaluations supporting applications in antimicrobial, wound care, and surgical markets.

Under a distribution agreement signed earlier this year, Clyra is advancing into the Europe-Middle East-Africa (EMEA) region through partnerships with international distributors. Initial product sales in the region are anticipated to begin in late 2025 or early 2026. Initial sales will be limited to those nation-states that recognize the existing FDA clearances, and others will require a CE Mark (an EU certification process to ensure health, safety and environmental protections standards are met), which is underway.

Global Wound Irrigation Solution Market Size

According to Fact.MR an international provider of data-driven market intelligence solutions across several industries, "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 growing number of chronic diseases like diabetes and vascular conditions leads to a higher demand for wound care solutions. Hospitals and clinics are increasingly adopting wound irrigation as a protocol to prevent surgical site infections.

Surgical Market Expansion

Following the execution of another distribution agreement in Q2 2025, Clyra has achieved several key milestones toward the commercial launch of its surgical products. These milestones include completion of package and label design, as well as finalized product claims. The next steps, already in process, will focus on product stability testing, packaging validation, and process validation. Upon completion, the full package will undergo standard FDA submission and review.

Our major distribution partner has been engaged throughout every stage of development in preparation for launch. Together, we anticipate that Clyra's surgical application products will be made available at more than 6,000 hospitals, 6,300 ambulatory surgery centers, and 2,200 specialty wound care clinics across the United States.

Market Diversification and Innovation

Building on its proven platform technology, Clyra is developing new product delivery systems and expanded applications for infection prevention and wound management diversifying its offerings across multiple medical markets that management believes will expand the total addressable markets for Clyra products as they are commercialized.

Capital and Growth

Over the past 12 months Clyra has secured over $7.5 million in capital to support capital investments, product rollouts, manufacturing readiness, and market expansion. The company continues to evaluate strategic funding opportunities to sustain its growth trajectory and maximize shareholder value.

Executive Commentary

"We are excited to bring these innovations to market and see our years of development translate into real clinical impact," said Steve Harrison, CEO of Clyra Medical. "Our expanding team remains focused on delivering world-class antimicrobial solutions that improve patient care and safety. For more information, visit www.ClyraMedical.com."

"Clyra represents a major technical advancement in infection control and wound care," said Dennis P. Calvert, CEO of BioLargo and Chairman of Clyra Medical Technologies. "We believe its products will set a new standard in antimicrobial performance and deliver exceptional value to patients, clinicians, and shareholders as adoption expands globally. Clyra exemplifies BioLargo's mission to develop high-impact technologies that create meaningful value for humanity and our investors."

About Clyra Medical Technologies

Clyra Medical Technologies, a subsidiary of BioLargo, Inc., develops innovative antimicrobial and wound care products designed to advance infection control and improve healing outcomes across multiple medical markets. Learn more at www.ClyraMedical.com.

About BioLargo, Inc.

BioLargo, Inc. (OTCQX:BLGO) is a cleantech and life sciences innovator and engineering services solution provider. Its core products address PFAS contamination, achieve advanced water and wastewater treatment, control odor and VOCs, improve air quality, enable energy efficiency and safe on-site energy storage, and control infections and infectious disease. BioLargo's approach is to invent or acquire novel technologies, develop them into commercial offerings, and extend their reach through licensing and channel partnerships to maximize their impact. Visit www.BioLargo.com.

Contact Information

Dennis P. Calvert
President and CEO, BioLargo, Inc.
888-400-2863

Safe Harbor Act

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, those regarding BioLargo's ("the Company") expectations about anticipated revenue and plans for future operations. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied. More information on these risks and other potential factors is included in the Company's filings with the SEC, including its most recent Form 10-K, Form 10-Q, and subsequent filings. The Company assumes no obligation to update any forward-looking statements or information, which speak as of their respective dates.

SOURCE: BioLargo, Inc.

View the original press release on ACCESS Newswire

FAQ

When will Clyra Medical's ViaCLYR launch and will it affect BLGO stock?

Clyra expects ViaCLYR commercial availability in late 2025 or early 2026; investor impact depends on sales performance and regulatory timing.

How large is the wound irrigation market cited in the BLGO announcement?

The announcement cites a $732 million global wound irrigation market in 2024 with a 3.4% CAGR to 2034.

What regulatory steps could delay Clyra product sales mentioned by BLGO (OTCQX:BLGO)?

EMEA sales may require a CE Mark, and U.S. launches are pending completion of stability testing and FDA submission/review.

How much capital has Clyra secured to support BLGO's product rollouts?

Clyra secured over $7.5 million in capital in the past 12 months for investments and manufacturing readiness.

What U.S. reach does BLGO say Clyra's surgical products will target?

Management anticipates availability at more than 6,000 hospitals, 6,300 ambulatory surgery centers, and 2,200 specialty wound clinics in the U.S.