• OrbusNeich set a plan to complete enrollment by end-2027 for its OM-0031 Japan pivotal trial of a coronary paclitaxel drug-coated balloon.
• Enrollment will run across 25 cardiovascular centers in Japan, targeting coronary artery disease patients including de novo lesions and in-stent restenosis.
• The study’s primary endpoint is target lesion failure at six months, positioning results as the key near-term value inflection.
• Clinical data is slated to support a PMDA regulatory submission, aiming for faster commercialization in Japan and a new growth driver.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. OrbusNeich Medical Group Holdings Ltd. published the original content used to generate this news brief via IIS, the regulatory disclosure system operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260722-12252677), on July 22, 2026, and is solely responsible for the information contained therein.