ACRO Biomedical Pioneers a New Era in Organ Transplantation

ACRO Biomedical (6748), leveraging its advanced medical technology, Supercritical Carbon Dioxide Platform Technology for Medical Applications, has continued its momentum following its recognition in 2023 with the Industrial Innovation Award from the biotechnology industry and the Silver Award in Manufacturing Technology from the National Pharmaceutical Technology Research and Development Awards. In 2024, the company achieved another milestone as three of its Class III medical devices—ACBcolla® Hemostatic Collagen Matrix, Hemostatic ADM Scaffold, and Hemostatic ADM Paste—received regulatory approval from the Taiwan Food and Drug Administration (TFDA) on April 30.

Dr. Dar-Jen Hsieh, Chairman of ACRO Biomedical, emphasized that Class III medical devices are the highest-risk implantable medical devices, making TFDA approval the most challenging to obtain. Successfully securing three Class III medical device approvals simultaneously establishes a new benchmark in Taiwan’s medical device industry. These three advanced medical products are designed for internal and external wound management in major surgical procedures, effectively promoting wound healing and hemostasis. ACRO Biomedical’s achievements in regenerative medicine technology and product applications position it as a new leader in the field.

Additionally, ACRO Biomedical’s Class III Collagen Ophthalmic Matrix is currently under TFDA review. Due to insufficient supporting documentation, approval has not yet been granted. The company is actively compiling additional evidence and will submit supplementary documents for further review.

In April, ACRO Biomedical signed an agreement with Raptim Research Pvt. Ltd., an Indian CRO, to initiate a 150-patient clinical trial for corneal transplantation in India. The trial is expected to be completed within two years. Beyond securing regulatory approval in India, the clinical data—compliant with international Good Clinical Practice (GCP) standards—will also support regulatory applications to the U.S. FDA and the European CE certification process.

Furthermore, following its successful advancements in kidney regeneration, ACRO Biomedical is actively collaborating with Taiwan’s medical institutions on cardiac and hepatic regeneration studies. The company is also conducting rigorous homologous and xenogeneic kidney regeneration trials using decellularized organ scaffolds to facilitate in vivo organ reconstruction. Looking ahead, these innovations hold the potential to revolutionize organ transplantation, offering new hope to patients in need.

Beyond regenerative medicine, ACRO Biomedical is also making strides in cutting-edge biomedical research. Dr. Hsieh highlighted that due to the exceptional biocompatibility of ACRO Biomedical’s biomaterials, multiple research teams have expressed interest in collaborating on future applications in human-machine interfaces and brain-machine interfaces. Through these initiatives, ACRO Biomedical is poised to shape the future of human medicine and technological integration.

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