Understanding the Market | BIOHEART-B Rises Over 13% Again, RDN Catalysts Frequent This Year, Institutions Say BIOHEART's Commercialization is About to Accelerate

BIOHEART-B rose over 10% again, as of the time of writing, up 13.5%, priced at HKD 8.83, with a transaction volume of HKD 106 million. Huafu Securities released a research report stating that in March 2025, Boston Scientific will acquire SoniVie for a total price of USD 600 million, actively entering the RDN track; in August, the American College of Cardiology and the American Heart Association updated the hypertension treatment guidelines and included RDN in the guidelines with a Class IIb recommendation; the proposed national coverage decision for RDN released by the Centers for Medicare & Medicaid Services (CMS) in July, if approved, will significantly accelerate clinical promotion and application. The firm pointed out that percutaneous renal denervation (RDN) is a new device therapy for uncontrolled and resistant hypertension. According to Frost & Sullivan, the annual market size for RDN in China is expected to exceed RMB 10 billion by 2032. The firm noted that the BIOHEART Iberis RDN system is the only one in the world approved for dual access RDN via both the radial artery (TRA) and the femoral artery, with significant first-mover advantages. Domestically, it has formed a major strategic cooperation with Yuan Da Health and Blue Sail Bo Sheng in multiple countries and regions overseas; Germany and France have included Iberis RDN in their medical insurance, currently serving as a starting point for accelerating commercialization for BIOHEART