Yeju Medical (06929) completed clinical trials of self-developed drug-coated balloons in Japan and enrolled the first patient

According to the Zhitong Finance App, Yeju Medical (06929) announced that the key clinical trial (OM-0031) conducted in Japan has completed the first patient enrollment. This trial will evaluate coronary paclitaxel drug-coated balloons (“drug-coated balloons”, DCB) independently developed by the Group, marking an important step in consolidating the Group's leading position in the Japanese interventional cardiology market with a diversified product portfolio.

This novel drug-coated balloon inherits the Group's mature balloon technology platform and has excellent delivery efficiency, helping interventional physicians to cross complex and highly narrow lesion sites. The product also uses drug coating technology independently developed by the Group, which can efficiently and evenly deliver paclitaxel to arterial blood vessel walls, ensure accurate treatment doses, promote blood vessel healing, and maintain excellent circulation and passability. The device delivers antiproliferative drugs in a non-invasive manner and does not require permanent implants, meeting the critical clinical needs of modern interventional cardiology.

This OM-0031 clinical trial is a prospective, multi-center collaborative study aimed at critically evaluating the safety and efficacy of drug-coated balloons. The test subjects were patients with coronary artery disease, particularly the treatment of primary lesions in small blood vessels and large blood vessels, and stent restenosis (ISR). The primary end point of the study was to assess the incidence of target lesion failure (TLF) during a six-month follow-up.

The OM-0031 trial will continue to recruit patients from 25 top cardiovascular centers across Japan, with the goal of completing all enrollment by the end of 2027. After the follow-up phase is completed and data analysis is completed, the company plans to use relevant clinical data to support the submission of regulatory approval applications to the Japan Independent Administrative Institution Pharmaceuticals and Medical Devices Agency (PMDA) to introduce this advanced treatment plan to the Japanese market as soon as possible. The Group also anticipates that the product will create new growth opportunities and create long-term value for shareholders after commercialization in the strategic market of Japan.