BioLargo Subsidiary Clyra Medical Selects Keystone Industries to Support Manufacturing of its Medical Products

Rhea-AI Summary

BioLargo's subsidiary, Clyra Medical Technologies, has selected Keystone Industries to support the manufacturing of its medical products, specifically the Bioclynse surgical wound irrigation solution. Bioclynse is FDA 510(k) cleared, non-cytotoxic, and effective against biofilms, presenting significant benefits for patient outcomes in surgeries and dentistry. Keystone, a global manufacturer with over a century of experience, has committed significant investment in infrastructure to scale up production. Both companies have emphasized the importance of this collaboration for the successful market launch of Bioclynse.

Positive

• Clyra Medical's Bioclynse is FDA 510(k) cleared, ensuring regulatory compliance.
• Bioclynse offers several advantages: non-cytotoxic, non-sensitizing, no tissue damage, no rinse-out, non-staining, sustained multi-day efficacy, and effectiveness against biofilms.
• Keystone Industries has a century-long experience in the medical, dental, and pharmaceutical sectors, providing reliable manufacturing support.
• Significant investment by both companies suggests strong commitment and potential for successful scaling and market penetration.

Negative

• The need for substantial investment indicates significant upfront costs.
• The success of Bioclynse hinges on Keystone's ability to rapidly scale production, posing a potential risk if delays occur.
• Clyra continues to incur expenses to support the roll-out, which could impact short-term financial performance.

WESTMINSTER, CA / ACCESSWIRE / June 12, 2024 / BioLargo, Inc. (OTCQX:BLGO), a company that creates and commercializes sustainable technologies to solve tough environmental and cleantech challenges, announced that its subsidiary Clyra Medical Technologies, Inc. ("Clyra") has selected Keystone Industries, a global manufacturer of medical, dental and cosmetic products with distribution partners in more than 70 countries, to support manufacturing of its medical products. The relationship focuses on the build-out of scaled manufacturing capacity for Clyra's FDA 510(k) cleared Bioclynse surgical wound irrigation solution. Clyra and Keystone have been and continue to make significant investments to support the launch of Bioclynse.

Bioclynse is Clyra's FDA 510(k) cleared, safe, highly effective, broad spectrum wound irrigation solution with enormous potential to improve patient outcomes in applications like orthopaedic surgery and dentistry. Advantages of Bioclynse include:

• Non-cytotoxic, non-sensitizing, no damage to tissue
• No rinse-out required
• Non-staining
• Sustained multi-day efficacy
• Effective against biofilms

Cary Robinson, President and CEO of Keystone Industries, said, "We are excited to support Clyra Medical Technologies to bring Bioclynse to the market. Keystone has a century of experience in developing and manufacturing medical device, OTC and pharmaceutical products. We have committed a significant investment in our infrastructure to support the manufacturing of innovative products like Clyra's Bioclynse and can readily provide the needed support to scale up production rapidly."

Steve Harrison, President of Clyra Medical Technologies, commented, "We are continuing to work hard and spend money to support the scaled roll-out of the Bioclynse surgical wound irrigation solution. Finding a manufacturing partner willing to invest significant money in new equipment and dedicated space was critical to these efforts. We look forward to a long and mutually prosperous relationship with Keystone."

About BioLargo, Inc.

BioLargo, Inc. (OTCQB:BLGO) is a cleantech and life sciences innovator and engineering services solution provider. Our 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. Our approach is to invent or acquire novel technologies, develop them into product offerings, and extend their commercial reach through licensing and channel partnerships to maximize their impact. See our website at www.BioLargo.com.

About Keystone Industries, Inc.

Keystone Industries is a market leader with over 100 years experience in developing cosmetic, medical device, OTC and pharmaceutical products. The company operates through a diverse network of over 800 U.S. and international distribution partners in more than 70 countries. Keystone maintains FDA licensing, ISO 13485 (medical device) and 22716 certifications, as well as GMP certification and international product registrations. Keystone's commitment to innovation and quality ensures that the company consistently exceed the evolving needs of their customers. See our website at www.keystoneindustries.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 about BioLargo's (the "Company") expectations regarding anticipated revenue; and plans for future operations. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include without limitation: the effect of regional economic conditions on the Company's business, including effects on purchasing decisions by consumers and businesses; the ability of the Company to compete in markets that are highly competitive and subject to rapid technological change; the ability of the Company to manage frequent introductions and transitions of products and services, including delivering to the marketplace, and stimulating customer demand for, new products, services, and technological innovations on a timely basis; the dependency of the Company on the performance of distributors of the Company's products. More information on these risks and other potential factors that could affect the Company's business and financial results is included in the Company's filings with the SEC, including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's most recently filed periodic reports on Form 10-K and 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 accesswire.com

FAQ

What is the focus of Clyra Medical and Keystone Industries' collaboration?

The collaboration focuses on the manufacturing and scaled production of Clyra Medical's FDA 510(k) cleared Bioclynse surgical wound irrigation solution.

What are the benefits of Bioclynse?

Bioclynse is non-cytotoxic, non-sensitizing, requires no rinse-out, is non-staining, has sustained multi-day efficacy, and is effective against biofilms.

Who is supporting the manufacturing of Clyra Medical's products?

Keystone Industries, a global manufacturer with over a century of experience, is supporting the manufacturing of Clyra Medical's products.

What is the significance of the FDA 510(k) clearance for Bioclynse?

The FDA 510(k) clearance indicates that Bioclynse meets regulatory standards for safety and efficacy, which is important for market acceptance.

What potential risks are involved in the Clyra Medical and Keystone Industries partnership?

Potential risks include significant upfront investment costs and the reliance on Keystone’s ability to rapidly scale production without delays.