AAI, teemed with experienced local talents and leadership, works with the business group to complete high-barrier CDSCO registration and importation of medical devices, including the group’s own high-risk implants under the ologen® brand. By the end of 2019, the group’s ologen® Collagen Matrix has been adopted by medical practitioners coming from every state and used in more than 10,000 ophthalmic surgeries.
At the same time, AAI works with the group closely to conduct post-market surveillance and clinical studies to monitor product safety and efficacy on an ongoing basis. To date, there have been more than 20 journal articles reviewing clinical outcomes of the group’s product, from studies carried out at local medical universities, and led by leading ophthalmologists. The clinical adoption of the group’s product is expected to continue its growth with the amount of evidence accumulated, resulting in higher patient benefit.