HONG KONG, July 22, 2026 - (ACN Newswire) - OrbusNeich Medical Group Holdings Limited (“OrbusNeich” or the “Group”; stock code: 6929), a multinational medical device company specializing in interventional devices for percutaneous coronary intervention (“PCI”) and percutaneous transluminal angioplasty (“PTA”), today announced the successful enrollment of the first patient in its pivotal Japanese clinical trial (OM-0031). This 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 leading position in Japan’s interventional cardiology market through its diversified product portfolio.

Built upon OrbusNeich’s well-established balloon platform, the innovative drug-coated balloon is engineered for outstanding deliverability, allowing interventionalists to easily navigate complex and severely stenotic lesions. The device also adopts OrbusNeich’s proprietary drug-coating technology, which enables the highly efficient and uniform paclitaxel transfer onto the arterial wall. This thoughtful technical pairing ensures precise therapeutic dosing and supports favorable vascular healing while maintaining robust trackability and crossability. By delivering anti-proliferative medicine non-invasively without leaving a permanent implant, the device addresses critical 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-center study designed to rigorously evaluate the safety and efficacy of the DCB. The trial targets patients suffering from coronary artery disease, with a particular 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.

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’. 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 of OM-0031 is expected to continue across 25 leading cardiovascular centers 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 advanced treatment option to the Japanese market as swiftly as possible. Commercializing the product in this strategic market is expected to create new growth opportunities and deliver long-term value to shareholders.

About OrbusNeich Medical Group Holdings Limited

OrbusNeich is a multinational medical device company specializing in interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures. Headquartered in Hong Kong, China, our Group sells its products in more than 70 countries and regions worldwide. It is also actively expanding into structural heart disease. With an in-house R&D team boasting over 20 years of product development expertise, our Group has developed world-leading proprietary technologies.

For more information, please visit the Group’s official website: https://orbusneich.com/.

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