Yejü Medical's self-developed drug-coated balloon has begun clinical trials in Japan, with the first patient enrolled.

Yejui Medical's self-developed drug-coated balloon begins clinical trials in Japan; first patient enrolled

Global medical device manufacturing company Yejui Medical Group Holdings Limited ("Yejui Medical" or "the Group"; Stock Code: 6929), specializing in interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures, announced today that its pivotal clinical trial (OM-0031) conducted in Japan has completed the enrollment of its first patient. This trial will evaluate the Group's self-developed paclitaxel drug-coated balloon (DCB), marking an important step for the Group to consolidate its leadership position in the Japanese interventional cardiology market with its diversified product portfolio.

This new drug-coated balloon inherits Yejui Medical's mature balloon technology platform, featuring excellent deliverability to help interventional physicians navigate complex and highly stenotic lesions. The product also utilizes Yejui Medical's proprietary drug coating technology, which efficiently and uniformly delivers paclitaxel to the arterial vessel wall, ensuring precise therapeutic dosing, promoting vessel healing, while maintaining superior trackability and crossability. The device delivers anti-proliferative drugs via a non-invasive method without requiring permanent implantation, meeting key clinical needs in modern interventional cardiology.

The principal investigator for the OM-0031 clinical study is Dr. Shigeru Saito, Director of the Cardiology Center at Shonan Kamakura General Hospital. This clinical trial is a prospective, multicenter cooperative study aimed at rigorously evaluating the safety and efficacy of the drug-coated balloon. The trial targets patients with coronary artery disease, specifically focusing on de novo lesions in small and large vessels, as well as the treatment of in-stent restenosis. The primary endpoint of the study is the incidence of Target Lesion Failure (TLF) assessed at six-month follow-up.

Mr. Qian Yongxun, Chairman, Executive Director, and Chief Executive Officer of Yejui Medical, stated: "The completion of the first patient enrollment in this Japanese clinical trial is a significant milestone for the Group's journey towards the era of 'intervention without implantation.' Launching this pivotal clinical trial in one of the core markets of our global strategic blueprint not only reaffirms Yejui Medical's advanced R&D capabilities on the international stage but also demonstrates our commitment to providing innovative, high-quality medical device solutions to meet the evolving needs of interventional cardiologists and improve the quality of life for patients worldwide."

The OM-0031 trial will continue to recruit patients across 25 top cardiovascular centers nationwide in Japan, with the goal of completing all enrollments by the end of 2027. After the follow-up phase concludes and data analysis is completed, Yejui Medical plans to utilize the relevant clinical data to support regulatory approval applications submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, aiming to introduce this advanced treatment solution to the Japanese market as soon as possible. The Group also expects that after the commercialization of this product in Japan, a strategic market, it will create new growth opportunities and generate long-term value for shareholders.

About Yejui Medical Group Holdings Limited

Yejui Medical is a global medical device company specializing in the production of interventional devices for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). Headquartered in Hong Kong, China, the Group's products are sold to over 70 countries and regions worldwide. The Group is also actively expanding its business into the field of structural heart disease. With an internal R&D team possessing over 20 years of product development experience, the Group has developed world-leading proprietary technologies.