ECM Biomedical Expands Its Human Tissue Platform

Six Additional Human Tissue Bank Categories Approved Following TFDA On-Site Inspection, Strengthening Regenerative Medicine Applications

Issued by: ECM Biomedical – Marketing & Public Relations Department

ECM Biomedical today announced the successful completion of the Taiwan Food and Drug Administration (TFDA) on-site inspection for the expansion of its Human Tissue Bank, adding six new tissue categories, including skin, cortical bone, cartilage, fascia, ligaments, and bone particulate. This milestone further strengthens the Company's human tissue platform, enhances its capabilities in tissue preservation, manufacturing, and clinical translation, and marks another significant step in advancing Taiwan's regenerative medicine industry.

The expansion represents an important milestone in ECM Biomedical's ongoing development of an integrated human tissue platform spanning both soft and hard tissue applications. The enhanced tissue portfolio is expected to support a broader range of clinical specialties, including orthopedics, sports medicine, neurosurgery, reconstructive surgery, dentistry, aesthetic medicine, and rehabilitation medicine, providing clinicians with more comprehensive solutions for tissue repair and regeneration.

Building a Comprehensive Human Tissue Portfolio

As regenerative medicine continues to evolve worldwide, human tissue products are playing an increasingly important role in tissue repair and reconstructive therapies. ECM Biomedical has continued to invest in advanced tissue preservation technologies, proprietary tissue processing methods, and robust quality management systems to support the development of innovative regenerative medicine solutions.

With the addition of these new tissue bank categories, the Company has further expanded its Human Tissue Portfolio, which now includes amniotic membrane, acellular dermal matrix (ADM), human bone allografts, skin, cartilage, fascia, ligaments, and bone particulate. This comprehensive portfolio enables ECM Biomedical to provide healthcare professionals with a wider range of human tissue-based solutions across multiple clinical specialties.

Strengthening Core Manufacturing and Quality Capabilities

Human tissue products require stringent regulatory oversight throughout every stage of procurement, processing, preservation, manufacturing, and quality assurance.

ECM Biomedical continues to operate in accordance with TFDA Human Tissue Bank regulations while implementing manufacturing processes and quality management systems aligned with international standards. These capabilities ensure product safety, manufacturing consistency, full traceability, and reliable quality throughout the production lifecycle.

The successful completion of the TFDA on-site inspection further demonstrates the Company's growing expertise in human tissue preservation and manufacturing, while providing a strong foundation for future product innovation, clinical collaborations, and international market expansion.

Expanding the Future of Regenerative Medicine

Driven by the increasing demand for precision medicine and the challenges of an aging population, regenerative medicine has become one of the fastest-growing areas in modern healthcare.

ECM Biomedical remains committed to advancing the clinical applications of amniotic membrane, acellular dermal matrix, human bone allografts, and other human tissue products across multiple medical specialties. Through continuous investment in research and development, strategic collaborations, and manufacturing excellence, the Company aims to accelerate innovation in regenerative medicine and expand access to advanced human tissue-based therapies.

Looking ahead, ECM Biomedical will continue to leverage its integrated human tissue platform, proprietary technologies, and internationally aligned quality systems to deliver innovative regenerative medicine solutions. By strengthening global partnerships and expanding its international presence, the Company is committed to becoming one of Asia's leading innovators in human tissue regenerative medicine.