BioLargo Subsidiary Clyra Medical Accelerates Toward Near-Term Product Launches and Global Expansion
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.
BioLargo (OTCQX:BLGO) ha annunciato che la sua controllata Clyra Medical sta avanzando verso lanci commerciali ed espansione internazionale dei suoi prodotti ViaCLYR per la irrigazione delle ferite e interventi chirurgici, con l’obiettivo di vendite iniziali negli Stati Uniti e in alcune aree dell'EMEA entro la fine del 2025 o all’inizio del 2026. Le attività chiave includono accordi di distribuzione per la copertura EMEA e USA, il completamento del design di confezione ed etichetta, la definizione delle affermazioni sul prodotto e la continua validazione di stabilità, imballaggio e processi prima della presentazione standard alla FDA e della relativa revisione. Clyra ha assicurato $7.5 million di capitale per sostenere la prontezza di produzione e i rollout. Il contesto di mercato indica un mercato di $732 million per l’irrigazione di ferite nel 2024, con un CAGR del 3,4% sino al 2034.
BioLargo (OTCQX:BLGO) anunció que su subsidiaria Clyra Medical avanza hacia lanzamientos comerciales y expansión internacional de sus productos ViaCLYR para irrigación de heridas y procedimientos quirúrgicos, con miras a ventas iniciales en Estados Unidos y en áreas selectas de EMEA a finales de 2025 o principios de 2026. Las actividades clave incluyen acuerdos de distribución para el alcance en EMEA y EE. UU., la finalización del diseño de envases y etiquetas, la definición de las reclamaciones del producto y la validación continua de estabilidad, empaque y procesos antes de la presentación y revisión estándar ante la FDA. Clyra ha asegurado $7.5 million de capital para apoyar la preparación de fabricación y los despliegues. El contexto de mercado indica un mercado de irrigación de heridas de $732 million en 2024, con una CAGR del 3,4% hasta 2034.
BioLargo (OTCQX:BLGO)가 자회사 Clyra Medical이 ViaCLYR 상처 세척 및 외과용 제품의 상업적 출시와 국제 확장을 추진하고 있으며, 미국 및 선택된 EMEA 지역에서의 초기 판매를 2025년 말 또는 2026년 초로 목표하고 있다고 발표했습니다. 주요 활동으로는 EMEA 및 미국 도달 범위를 위한 유통업체 계약 체결, 포장 및 라벨 디자인 완료, 제품 주장 확정, 안정성, 포장 및 공정 검증의 지속적 진행이 있으며, 표준 FDA 제출 및 심사에 앞서 진행됩니다. Clyra는 제조 준비 및 롤아웃을 지원하기 위해 $7.5 million의 자금을 확보했습니다. 시장 맥락은 2024년 창상 세척 시장이 $732 million이고 2034년까지 연평균 3.4% 성장할 것으로 보고합니다.
BioLargo (OTCQX:BLGO) a annoncé que sa filiale Clyra Medical progresse vers des lancements commerciaux et une expansion internationale de ses produits ViaCLYR pour l’irrigation des plaies et les procédures chirurgicales, avec pour objectif des ventes initiales aux États-Unis et dans certaines zones EMEA à la fin de 2025 ou au début de 2026. Les activités clés comprennent des accords de distribution pour la couverture EMEA et US, l’achèvement de la conception des emballages et des étiquettes, la finalisation des revendications produit et la validation continue de la stabilité, de l’emballage et des procédés avant une soumission FDA standard et l’examen. Clyra a obtenu $7.5 million de capital pour soutenir la préparation à la fabrication et les déploiements. Le contexte du marché indique un marché d’irrigation des plaies de $732 million en 2024, avec un CAGR de 3,4 % jusqu’en 2034.
BioLargo (OTCQX:BLGO) gab bekannt, dass seine Tochtergesellschaft Clyra Medical Fortschritte bei kommerziellen Markteinführungen und internationaler Expansion ihrer ViaCLYR-Wundspül- und chirurgischen Produkte macht und dass erste Verkäufe in den USA sowie in ausgewählten EMEA-Regionen Ende 2025 oder Anfang 2026 angestrebt sind. Zu den wichtigsten Aktivitäten gehören Vertriebsvereinbarungen für Reichweite in EMEA und den USA, Abschluss von Verpackungs- und Etikettendesign, Festlegung der Produktansprüche sowie fortlaufende Stabilitäts-, Verpackungs- und Prozessvalidierung vor einer standardmäßigen FDA-Einreichung und -Prüfung. Clyra hat $7.5 million USD Kapital gesichert, um die Herstellungsbereitschaft und Rollouts zu unterstützen. Der Markt kontext verweist auf einen Wundspülmarkt von $732 million im Jahr 2024, mit einer CAGR von 3,4 % bis 2034.
BioLargo (OTCQX:BLGO) أعلنت أن شركتها التابعة Clyra Medical تتقدم نحو الإطلاق التجاري والتوسع الدولي لمنتجاتها ViaCLYR لغسل الجروح والجراحات، مع هدف المبيعات الأولية في الولايات المتحدة وبؤر مختارة من EMEA في أواخر 2025 أو بداية 2026. تشمل الأنشطة الرئيسية اتفاقيات توزيع للوصول إلى أسواق EMEA والولايات المتحدة، والانتهاء من تصميم التغليف والملصقات، وتحديد ادعاءات المنتج، والاعتماد المستمر على الاستقرار والتعبئة والتحقق من العمليات قبل التقديم للمراجعة القياسية من FDA. 应 Clyra يكتسب $7.5 million من رأس المال لدعم الاستعداد التصنيعي والت rollout. يشير سياق السوق إلى سوق تطهير الجروح بقيمة $732 million في 2024 مع معدل نمو مركب سنوي قدره 3.4% حتى 2034.
BioLargo (OTCQX:BLGO)宣布其子公司 Clyra Medical 正在推进 ViaCLYR 创伤冲洗与外科产品的商业化上市和全球扩张，目标是在美国和部分 EMEA地区实现初步销售，时间为 2025 年底或 2026 年初。主要工作包括为 EMEA 和美国市场的覆盖范围签订分销协议、完成包装与标签设计、最终确定产品声明，以及在标准 FDA 提交与审查前进行持续的稳定性、包装和工艺验证。Clyra 已获得 $7.5 million 美元资本，用于支持制造就绪与推广上线。市场背景显示，2024 年创伤冲洗市场规模为 $732 million，预计到 2034 年将以 3.4% 的年复合增长率增长。
- $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
- EMEA sales limited until CE Mark secured
- Commercial launch subject to FDA submission and review
Initial Commercialization Targeting
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
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
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
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