ORBUSNEICH (06929) independently developed drug-coated balloon completed the first patient enrollment in clinical trials in Japan.

ORBUSNEICH(06929) announced that the key clinical trial (OM-0031) conducted in Japan has recruited its first patient. This trial will evaluate the company's self-developed drug-coated balloon (DCB) for coronary artery using paclitaxel, marking an important step for the company to consolidate its leading position in the Japanese interventional cardiology market with a diversified product portfolio. This new drug-coated balloon inherits the company's mature balloon technology platform, with excellent delivery efficiency to help interventional physicians navigate through complex and highly narrowed lesion sites. The product also utilizes the company's self-developed drug-coating technology to efficiently and evenly deliver paclitaxel to the arterial wall, ensuring precise treatment dosage, promoting vessel healing, while maintaining excellent trackability and passage. The device delivers anti-proliferative drugs in a non-invasive manner without the need for permanent implants, meeting key clinical needs in modern interventional cardiology. The OM-0031 clinical trial is a prospective, multicenter collaborative study aimed at rigorously evaluating the safety and efficacy of the drug-coated balloon. The trial targets patients with coronary artery disease, particularly focusing on lesions in small and large vessels, as well as in-stent restenosis (ISR) treatment. The main endpoint of the study is to evaluate the rate of target lesion failure (TLF) at six-month follow-up. The OM-0031 trial will continue to recruit patients at 25 top cardiovascular centers nationwide in Japan, with the goal of completing recruitment by the end of 2027. After the follow-up phase and data analysis are completed, the company plans to use the relevant clinical data to support the submission of regulatory approval applications to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to quickly introduce this advanced treatment into the Japanese market. The company also expects that commercializing this product in Japan, a strategic market, will create new growth opportunities and generate long-term value for shareholders.