OrbusNeich has enrolled the first patient in its pivotal Japanese clinical trial evaluating its proprietary coronary paclitaxel drug‑coated balloon. The milestone strengthens the Group’s position in Japan’s interventional cardiology market through continued expansion of its product portfolio.
Built on OrbusNeich’s established balloon platform, the device is designed for strong deliverability, enabling clinicians to navigate complex and severely stenotic lesions. It incorporates the Group’s drug‑coating technology to ensure efficient and uniform paclitaxel transfer to the arterial wall. This pairing supports precise dosing and favourable vascular healing while maintaining trackability and crossability.
By delivering anti‑proliferative medicine without leaving a permanent implant, the device aims to meet key clinical needs in modern interventional cardiology.
The Coordinating Investigator for the OM‑0031 study is Dr Shigeru Saito, Director of Heart Center at Shonan Kamakura General Hospital. The prospective, multi‑centre trial will assess safety and efficacy in patients with coronary artery disease, focusing on de novo lesions in small and large vessels and in‑stent restenosis. The primary endpoint is target lesion failure at six months.
Mr David Chien, Chairman, Executive Director and Chief Executive Officer of OrbusNeich, said: “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’.”
He added: “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.”
Patient enrollment is expected to continue across 25 cardiovascular centres in Japan, with completion targeted by the end of 2027.
Following follow‑up and data analysis, OrbusNeich plans to use the results to support regulatory submission to Japan’s Pharmaceuticals and Medical Devices Agency, aiming to bring the treatment to market swiftly and create long‑term value for shareholders.
