ECM Biomedical Secures TFDA Establishment Permits for Human Organ Preservation Banks, Advancing a Globally Competitive Human Tissue Regenerative Medicine Platform

Issued by: Marketing and Public Relations Department, ECM Biomedical

ECM Biomedical announced that it has officially obtained establishment permits from the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, for human organ preservation banks covering bone, bone powder, and skin. With preservation banks now established for amniotic membrane, skin, bone, and bone powder, the company has further completed its integrated human tissue product and technology platform, demonstrating its capabilities in regenerative medicine, human tissue preservation, and processing technology.

The newly granted TFDA permits represent another significant milestone for ECM Biomedical in quality management, human tissue preservation, and regulatory compliance. They also strengthen the company’s overall human tissue product portfolio, laying a solid foundation for clinical applications, product development, and international market expansion.

Building a Comprehensive Human Tissue Product Platform

ECM Biomedical has established three major human tissue product platforms encompassing amniotic membrane, acellular dermal matrix, and human bone allografts. These products support applications across orthopedics, rehabilitation medicine, sports medicine, plastic and reconstructive surgery, aesthetic medicine, dentistry, neurosurgery, and other areas of regenerative medicine, providing clinicians with a broader range of human tissue repair solutions.

This comprehensive human tissue product portfolio not only enhances the company’s product development capabilities but also establishes a competitive advantage in multidisciplinary clinical integration, further expanding the clinical value of human tissues in regenerative medicine.

Establishing a Leading Position in Taiwan’s Core Human Tissue Technologies

Based on its current product and technology portfolio, ECM Biomedical is the only biomedical company in Taiwan with proprietary acellular dermal matrix product technology and the only biomedical company in Taiwan with demineralized bone matrix (DBM) product technology.

The company has also established a comprehensive human tissue platform encompassing amniotic membrane, bone allografts, and acellular dermal matrix. This positions ECM Biomedical as the only biomedical company in Asia with an integrated technology platform covering all three product categories, demonstrating its technological integration capabilities and innovative advantages in human tissue–based regenerative medicine.

Driving the Future of Regenerative Medicine Through an Integrated Technology Platform

ECM Biomedical stated that it will continue investing in human tissue preservation, manufacturing processes, quality management, and the development of its core technology platforms. The company will further advance the clinical applications of amniotic membrane, acellular dermal matrix, and bone allograft products across multiple medical specialties while actively expanding international partnerships and overseas markets.

Looking ahead, ECM Biomedical will build upon its comprehensive human tissue product platform and proprietary core technologies to drive continued innovation in regenerative medicine and develop internationally competitive human tissue solutions. Guided by its vision of “Asia Leadership, Global Reach,” the company aims to become a leading Asian enterprise in human tissue–based regenerative medicine with a growing global presence.