ORBUSNEICH (06929.HK): First Patient Enrolled in Pivotal Japanese Clinical Trial for Self-developed Drug-Coated Balloon
NewTimeSpace News: ORBUSNEICH (06929.HK) announced that the first patient has been enrolled in OM-0031, the pivotal clinical trial of its coronary paclitaxel drug-coated balloon (DCB) in Japan. The trial evaluates the safety and efficacy of the Group’s self-developed DCB product. It will be conducted across 25 leading cardiovascular centres nationwide in Japan, with full enrolment targeted by the end of 2027.
NewTimeSpace News: On 22 July 2026, ORBUSNEICH (06929.HK) issued a voluntary announcement, disclosing the enrolment of the first patient in the Japanese clinical trial for its in-house developed drug-coated balloon.
Built upon the Group’s mature balloon technology platform, this novel drug-coated balloon delivers outstanding trackability and crossability. Adopting proprietary drug-coating technology, it transfers paclitaxel efficiently and uniformly onto arterial vessel walls to achieve precise therapeutic dosing, facilitating vascular healing. The device delivers anti-proliferative agents via a minimally invasive approach without permanent implant retention.
Trial OM-0031 is a prospective, multicentre collaborative study assessing the safety and efficacy of the drug-coated balloon for patients with coronary artery disease, targeting de novo lesions in small and large vessels as well as in-stent restenosis. The primary endpoint is the rate of target lesion failure at six-month follow-up. The trial will be carried out at 25 top-tier cardiovascular centres throughout Japan, aiming to complete full enrolment by the end of 2027.
Upon data readout, the Group intends to leverage the clinical results to support regulatory filing with PMDA in Japan. The Group expects the product to unlock new growth opportunities following commercialisation in Japan.
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