ECM Biomedical Completes Construction of Its ISO Class 7 Cleanroom Manufacturing Facility

Environmental Validation Marks a Major Milestone in Human Tissue Manufacturing and Quality Management

Issued by: ECM Biomedical – Marketing & Public Relations Department

Taipei, Taiwan — ECM Biomedical today announced the completion of its ISO Class 7 (Class 10,000) Cleanroom Manufacturing Facility, which has successfully passed environmental validation. The new facility provides a manufacturing environment that meets international standards for human tissue preservation, processing, and quality management, representing a significant milestone in the Company's regenerative medicine manufacturing capabilities.

The completion of the cleanroom facility reflects ECM Biomedical's long-term commitment to investing in advanced manufacturing infrastructure and quality systems. It also establishes a strong foundation for the research, development, manufacturing, and future clinical application of human tissue products while strengthening the Company's regulatory compliance and manufacturing excellence.

Establishing an International-Standard Human Tissue Manufacturing Environment

Manufacturing human tissue products requires stringent environmental control, microbiological management, and comprehensive quality systems throughout the production process.

From the earliest stages of facility planning, ECM Biomedical designed its manufacturing environment to meet internationally recognized quality standards. The Company has completed an ISO Class 7 (Class 10,000) cleanroom manufacturing facility and successfully achieved environmental validation, ensuring that human tissue processing and manufacturing are performed under tightly controlled conditions.

The facility incorporates comprehensive environmental controls, including temperature and humidity regulation, airborne particulate monitoring, differential pressure control, and continuous environmental monitoring. Together, these systems provide a stable and controlled manufacturing environment that supports the consistent production of high-quality human tissue products.

Building the Foundation for an Integrated Human Tissue Platform

The completion of the cleanroom manufacturing facility represents a key milestone in the development of ECM Biomedical's integrated human tissue platform. It also establishes the essential infrastructure for future human tissue banking, product development, and manufacturing process optimization.

ECM Biomedical continues to expand its regenerative medicine portfolio, which includes Amniotic Membrane, Acellular Dermal Matrix (ADM), and Human Bone Allografts, while progressively extending its capabilities to additional human tissue products such as skin, cartilage, fascia, and ligaments. Together, these technologies form a comprehensive Human Tissue Portfolio supporting a wide range of regenerative medicine applications.

Driving Innovation Through Quality Management

ECM Biomedical believes that a high-quality manufacturing environment is fundamental to ensuring the safety, consistency, and traceability of human tissue products.

The Company continues to operate in accordance with Taiwan Food and Drug Administration (TFDA) Human Tissue Bank regulations while implementing internationally aligned quality management systems and standardized operating procedures. These efforts further strengthen manufacturing process control, product quality, and regulatory compliance.

Looking ahead, ECM Biomedical will continue investing in advanced cleanroom technologies, intelligent manufacturing, and quality management systems to enhance manufacturing efficiency, accelerate product innovation, and support the expanding clinical applications of regenerative medicine.

Advancing the Future of Human Tissue Regenerative Medicine

ECM Biomedical stated that the completion of its ISO Class 7 Cleanroom Manufacturing Facility represents an important milestone in the Company's long-term commitment to regenerative medicine.

Moving forward, the Company will continue to strengthen its expertise in human tissue preservation, manufacturing technologies, and international quality management while collaborating with healthcare institutions and global partners. Through continuous innovation and manufacturing excellence, ECM Biomedical aims to deliver high-quality human tissue solutions and contribute to the advancement of regenerative medicine in Taiwan and around the world.