- 2022-12-27
- Starting With Collagen Ophthalmic Matrix, ACRO Biomedical Hopes to Become a Global Supplier of Transplant Organs with Its Patented Platform Technology
After years of R&D and refinement, ACRO Biomedical will complete human clinical trials for ABCcolla® Collagen Ophthalmic Matrix in October 2022. ABCcolla® Collagen Ophthalmic Matrix is the leading product of ACRO Biomedical’s organ engineering research. Utilizing the patented core technology, supercritical carbon dioxide decellularization platform technology, ACRO Biomedical wishes to decellularize the heart, liver, kidney, pancreas, brain and other organs, and reconstruct the organs in vivo.
According to the MarketsandMarkets Research report in 2021, the artificial cornea and corneal transplant market will grow from US$4.18 billion in 2021 to US$5.99 billion in 2026, with an average CAGR of 7.4%. At present, the relatively well-developed markets are still in Europe and America, but in developing countries such as China and India, it is estimated that hundreds of thousands of new cases will be added every year. The number of potential patients and the market cannot be underestimated. ACRO Biomedical has spotted the huge market for corneal transplantation. Starting from Taiwan's research and development, ACRO Biomedical is preparing to hit the markets of the world's two largest countries with the largest populations.
After Years of Research and Development, ABCcolla® Collagen Ophthalmic Matrix Will Apply for Medical Device Marketing Authorization after GCP Review
After years of R&D and refinement, ABCcolla® Collagen Ophthalmic Matrix has completed human clinical trials in October 2022. It is expected to apply for marketing approval from the Ministry of Health and Welfare after the GCP review, so that patients with eye diseases no longer have to wait in line for corneal donation.
【R&D Progress of ABCcolla® Collagen Ophthalmic Matrix】
- 2016 - Conducted world's first successful canine corneal transplantation and was interviewed and broadcasted by the Discovery Channel
- 2017 - Completed the efficacy test on rabbit model and published an international journal article
- 2018 - The physicochemical properties test of the product was completed, and was approved by the Ministry of Health and Welfare for human clinical trials
- 2019 - Successively approved for human clinical trials from three medical centers, and began to implement human clinical trials
- 2021 - Passed the three-year real time stability test, published an international journal article, and approved by the Ministry of Economic Affairs as a biotech and new drugs company
- 2022 - The upper limit of cases was reached and the full observation period was completed
ACRO Biomedical is currently more focused on China and India, two countries with the largest population in the world. It is expected to obtain Taiwan TFDA approval first, and then authorize Chinese partners to conduct human clinical trials in China and distribution all over China. The business model of marketing in China is to collect out-licensing fees and sales profits or royalties. At the same time, ACRO Biomedical will also conduct large-scale human clinical trials in India, and the test results will be used as evidence for FDA in India, the European Union and the United States, and marketed in the global market accordingly.
Not Only in the Corneal Transplant Market, ACRO Biomedical Also Hopes to Become an Organ Supplier for Clinical Transplantation
ABCcolla® Collagen Ophthalmic Matrix is the leading product of ACRO Biomedical’s organ engineering research. Using the patented core technology, supercritical carbon dioxide decellularization platform technology, ACRO Biomedical is able to decellularize the heart, liver, kidney, pancreas, brain and other organs, and then implanted in animals, by connecting blood vessels, the blood flow brings stem cells to reconstruct the implanted organ scaffolds. At present, kidney reconstruction in vivo have achieved good results. In addition to the cornea, ACRO Biomedical also hopes to utilize the decellularization platform to develop 3D printing of organ powder to replace the current clinical organ transplantation.
