ACRO Biomedical Co., Ltd. (TWSE: 6748) announced today that its ABCcolla® Collagen Ophthalmic Matrix has received regulatory approval from Taiwan's Ministry of Health and Welfare (MOHW), marking a significant advancement in corneal transplantation technology. The product, registered under MOHW Medical Device No. 008155, offers new hope for millions of patients worldwide awaiting corneal transplants.
The approval comes at a critical time when the global need for corneal transplants far exceeds available donor tissue. According to the World Health Organization, over 20 million people suffer from blindness due to corneal injuries or infections, yet only approximately 100,000 corneal transplants are performed annually due to severe donor shortages.
Innovative Decellularization Technology
ABCcolla® Collagen Ophthalmic Matrix represents a technological breakthrough as the world's first and only product utilizing supercritical carbon dioxide decellularization technology. This proprietary process completely removes cells and impurities from animal-derived corneal tissue while preserving the intact collagen scaffold structure.
"Our vision is to address the global shortage of transplantable tissues and organs, ensuring that every patient in need of a corneal transplant can receive timely treatment," said Dr. DJ Hsieh, Chairman and CEO of ACRO Biomedical. "This approval not only validates our technology but also brings hope to those awaiting transplantation."
The innovative approach enhances biocompatibility, biodegradability, and tissue regeneration capabilities of the final product. ACRO Biomedical's technology has secured patents in 15 countries and received recognition with the Silver Award at the 2023 National Pharmaceutical Technology R&D Awards.
Clinical Applications and Market Potential
ACRO Biomedical developed the product using porcine corneas, which closely resemble human corneal structure. Once cellular components are removed through the company's proprietary process, the resulting material serves as a biocompatible alternative to donated human corneas with reduced risk of immune rejection.
Clinical trials have demonstrated the product's effectiveness for patients suffering from corneal damage caused by:
- Corneal melting
- Trauma
- Infections
The global corneal transplant market is projected to grow substantially in coming years. According to Global Market Insights, Inc., the market is estimated to reach $500 million in 2024 and is expected to grow to $1 billion by 2033, representing a compound annual growth rate (CAGR) of 7.59% from 2025 to 2033.
Addressing Unmet Medical Needs
Currently, no similar products exist in the Taiwanese market, positioning ACRO Biomedical as a pioneer in this therapeutic area. The company is now preparing for product commercialization to meet market demand and improve patient quality of life.
The approval is particularly significant given the aging global population, increasing prevalence of corneal diseases, and rising awareness of vision health. By advancing this breakthrough technology, ACRO Biomedical aims to reduce dependency on donated corneas and restore sight for more patients worldwide.
The company remains committed to ongoing innovation in regenerative medicine, with ambitions to become a global leader in the field of tissue engineering and transplantation alternatives.
