Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185), a leading Chinese innovator in interventional cardiovascular devices, has announced plans for an initial public offering (IPO) on Shanghai’s Sci-Tech Innovation Board (STAR) following its HKD 440 million (USD 56 million) Hong Kong debut in November 2023. The move underscores the company’s ambition to accelerate development of its pipeline, including a next-generation bioresorbable scaffold (BRS) system poised to set a global benchmark.
Core Products and Therapeutic Focus
Bio-Heart specializes in two critical cardiovascular therapies: (1) fully bioresorbable scaffolds (BRS) for coronary/peripheral artery disease and (2) renal denervation (RDN) for uncontrolled/intractable hypertension. Its flagship product, the Bioheart BRS system—a proprietary second-generation device developed via in-house R&D—is positioned to become the world’s first advanced bioresorbable scaffold, based on data from a multi-center, randomized, controlled clinical trial.
Clinical Milestones and Regulatory Fast-Track
The Bioheart BRS system achieved fast-track designation in China in February 2017, accelerating its path to market. Results from the clinical study highlight its potential to outperform existing first-generation BRS technologies, with superior efficacy and safety profiles. The device’s innovative design enables full resorption within 3 years, reducing long-term vascular complications—a key differentiator in the global interventional cardiology market.
IPO Strategy and Market Outlook
Proceeds from the STAR Board IPO will fuel Bio-Heart’s expansion plans, including scaling production, advancing R&D for RDN therapies, and pursuing international approvals. The company’s dual-listing strategy reflects growing demand for cutting-edge cardiovascular solutions in China and abroad, where aging populations and rising chronic disease rates drive market growth.-Fineline Info & Tech
