OrbusNeich Medical Group Holdings Limited has announced the successful enrollment of the first patient in its pivotal Japanese clinical trial, OM-0031.
The trial will evaluate the Group’s proprietary coronary paclitaxel drug-coated balloon (DCB), marking a significant step forward for the Group in further consolidating its position in Japan’s interventional cardiology market through its diversified product portfolio.
Built upon OrbusNeich’s well-established balloon platform, the drug-coated balloon is engineered for deliverability, allowing interventionalists to navigate complex and severely stenotic lesions.
The device also adopts OrbusNeich’s proprietary drug-coating technology, which enables efficient and uniform paclitaxel transfer onto the arterial wall. By delivering anti-proliferative medicine non-invasively without leaving a permanent implant, the device addresses clinical needs in modern interventional cardiology.
The Coordinating Investigator of the OM-0031 clinical study is Dr Shigeru Saito, Director of Heart Center at Shonan Kamakura General Hospital. The clinical trial is a prospective, multi-centre study designed to evaluate the safety and efficacy of the DCB.
The trial targets patients with coronary artery disease, with a focus on the treatment of de novo lesions in both small and large vessels and in-stent restenosis (ISR).
The primary endpoint of the study will evaluate target lesion failure (TLF) at the six-month follow-up.
“The first patient enrollment in this Japanese clinical trial is an important milestone for the Group as we embrace an era of ‘leave nothing behind’. Launching this pivotal trial in one of the core markets of our global strategic blueprint not only reaffirms OrbusNeich’s advanced R&D capabilities on the international stage, but also underscores our steadfast commitment to providing innovative, high-quality medical device solutions that meet the evolving requirements of interventional cardiologists and improve the lives of patients worldwide,” said Mr David Chien, Chairman, Executive Director and Chief Executive Officer of OrbusNeich.
Patient enrollment of OM-0031 is expected to continue across 25 leading cardiovascular centres throughout Japan, with the goal of completing patient enrollment by the end of 2027.
Following the follow-up period and data analysis, OrbusNeich plans to use the clinical data to support its regulatory submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), with the aim of bringing this treatment option to the Japanese market.
