Yi'an Biomedical's minimally invasive medical material for benign prostatic hyperplasia has received marketing approval in Taiwan

Medical materials manufacturer Yi'an Biomedical (6499) announced today that Urocross, its innovative minimally invasive treatment for benign prostatic hypertrophy (BPH), has officially obtained Taiwan's marketing authorization, adding another important milestone to the product's global market layout.

This is Urocross’s further step in obtaining Taiwan’s marketing approval after it obtained 510(k) marketing approval from the US Food and Drug Administration (US FDA) in March this year and completed its first commercial application in the United States in October.

Urocross has obtained marketing approval from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare. Its clinically proven efficacy and safety are based on the Expander-1 feasibility trial and the Expander-2 multinational multi-center hub clinical trial. Part of the Expander-1 trial was conducted in Taiwan. Huang Zhiping, who participated in the Expander-1 clinical trial and is director of the Department of Urology at China Medical University Hospital, said: "The experience of using Urocross for experimental treatment shows that patients not only have improved urinary symptoms, but also have fewer complications during the operation. After the short-term stent is removed, the urinary improvement effect can be maintained for a long time. This technology also brings new treatment opportunities to patients who are not suitable for long-term medication or are worried about the impact of traditional surgery on sexual function."

Yi'an said that after successfully obtaining Taiwan's marketing authorization, the team will further promote the introduction of Urocross into the domestic medical system and simultaneously carry out product supply, sales channels, professional education and training and other related work. The company hopes to improve the preparations for market introduction, promote medical professionals' understanding of product characteristics and clinical evidence, and steadily and gradually establish the foundation for product application in Taiwan's medical environment.