ACRO Biomedical Secures Approval for Three Class III Regenerative Medical Devices

Following its recognition in 2023 with the Biotechnology Industry's "Industrial Innovation Award" and the National Pharmaceutical Technology R&D Award's "Silver Award for Manufacturing Technology," ACRO Biomedical (6748) has successfully translated its research achievements into market-ready products. On April 30, 2024, the Taiwan Food and Drug Administration (TFDA) granted Class III medical device approvals for three regenerative medical products—ACBcolla® Hemostatic Collagen Matrix, Hemostatic ADM Scaffold, and Hemostatic ADM Paste—marking a significant milestone in the company’s growth and development.

On May 27, ACRO Biomedical held its 2024 Annual General Meeting, during which Chairman Dr. Dar-Jen Hsieh reported on the company’s current operational status and future development plans. He also introduced Mr. Chih-Feng Lu, the incoming CEO, to the board of directors. With extensive expertise in biomedical technology and product marketing, Mr. Lu’s seasoned market strategies are expected to elevate ACRO Biomedical’s business operations and further solidify the company’s brand positioning in the biomedical investment sector.

Dr. Hsieh emphasized that ACRO Biomedical is among Taiwan’s pioneers in commercializing regenerative medical technology and products. The long-awaited passage of the Regenerative Medicine Act and the Regenerative Medicine Product Management Act on June 4, after a decade of legislative efforts, coincided with ACRO Biomedical’s three regenerative medical products receiving TFDA’s Class III medical device approvals. While this may be a coincidence, it underscores ACRO Biomedical’s relentless dedication to innovation. Additionally, the company’s Collagen Ophthalmic Matrix is still under regulatory review, as TFDA has requested supplementary documentation. ACRO Biomedical has since compiled the necessary supporting data and will submit the revised application shortly, anticipating approval in the near future.

Dr. Hsieh further highlighted that the company’s ophthalmic product had already obtained TFDA’s export approval in December 2023. India has been selected as the launch market for this product, and ACRO Biomedical carefully evaluated four international Contract Research Organizations (CROs) before selecting the most suitable partner for the clinical trials. The company plans to enroll 150 patients, with trial completion expected within 18 months. Notably, ACRO Biomedical’s artificial cornea has already undergone human clinical trials at Taiwan’s leading medical institutions, including Tri-Service General Hospital, Kaohsiung Veterans General Hospital, and Kaohsiung Medical University. These trials have provided critical insights and regulatory clearances that will greatly benefit the upcoming clinical trials in India.

To date, ACRO Biomedical has secured 71 invention patents worldwide, with an additional 20 patents under review. The company has rapidly translated its patented technologies into innovative biomedical products, with applications spanning wound care, dentistry, orthopedics, ophthalmology, and medical aesthetics. ACRO Biomedical is also advancing into organ regeneration, including heart, kidney, and liver reconstruction. The company envisions a future where patients no longer endure long waiting lists for organ transplants and aims to eradicate unethical organ harvesting practices globally.

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