ACRO Biomedical Secures Class III Certification for Three Advanced Medical Devices
Revolutionizing Internal and External Wound Care in Major Surgical Procedures, Setting a New Record in Taiwan’s Medical Device Industry
ACRO Biomedical Secures Three Class III Medical Device Approvals, Setting a New Benchmark in Taiwan's MedTech Industry
Pioneering Innovations in Regenerative Medicine, Expanding into Hair Regeneration and Aesthetic Applications
ACRO Biomedical, a leading regenerative medicine company based in the Southern Taiwan Science Park, has achieved a remarkable milestone by securing three Class III medical device approvals simultaneously from Taiwan’s Ministry of Health and Welfare (MOHW). In the medical device industry, products are classified into three levels based on their invasiveness and risk profile, with Class III representing the highest-risk implantable medical devices—making regulatory approval for such products particularly challenging. While many companies struggle to obtain even a single Class III medical device approval, ACRO Biomedical’s achievement of three approvals at once is poised to set a new record in Taiwan’s medical device sector.
According to Dr. Dar-Jen Hsieh, CEO of ACRO Biomedical, the three newly approved high-end medical devices include:
Hemostatic Collagen Matrix
Hemostatic ADM Scaffold
Hemostatic ADM Paste
All three products are designed for use in major surgical procedures, effectively promoting wound healing and hemostasis for both internal and external surgical wounds. The Collagen Hemostatic Dressing boasts a broad range of applications, including burns, trauma, ulcer wounds, and various surgical incisions. Similarly, the Decellularized Dermis Hemostatic Powder, packaged in a sterile powder form, can be directly applied to wounds to control bleeding and accelerate healing. Meanwhile, the Decellularized Dermis Hemostatic Gel, pre-filled in syringes, is also intended for use in burns, trauma, ulcers, and surgical wounds, providing a versatile and effective solution for hemostasis and wound care.
Dr. Hsieh further revealed an unexpected breakthrough during preclinical studies—the Decellularized Dermis Hemostatic Powder demonstrated a unique ability to promote hair regeneration. In light of this discovery, ACRO Biomedical is preparing to initiate clinical trials in collaboration with a medical center to validate its efficacy in human subjects. Additionally, the Decellularized Dermis Hemostatic Gel is set to undergo clinical trials for dermatological aesthetic applications, specifically for wrinkle filling, opening new commercial opportunities in the medical aesthetics sector.
Beyond these recent approvals, ACRO Biomedical is also making strides in ophthalmic regenerative medicine. The company’s Collagen Corneal Matrix, another Class III medical device, has been under extensive review by Taiwan’s MOHW, with official approval expected soon.
In a significant step toward global expansion, ACRO Biomedical signed an agreement in early April with India's leading CRO, Raptim Research Pvt. Ltd., to launch a 150-patient corneal transplant clinical trial in India. The trial is expected to conclude within two years, paving the way for regulatory approval not only in India but also in the United States (FDA) and the European Union (CE), as the study follows international Good Clinical Practice (GCP) standards.
With multiple Class III approvals in hand and a pipeline of groundbreaking medical innovations, ACRO Biomedical continues to push the boundaries of regenerative medicine, reinforcing its position as a leader in the global biomedicine industry.
URL:ACRO Biomedical Secures Class III Certification for Three Advanced Medical Devices