Shanghai Bio-heart Biological Technology Co., Ltd.
2185.HK
Hong Kong Stock Exchange3.02
HKD
+0.04
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Shanghai Bio-heart Biological Technology Co., Ltd.
2185.HK
(Hong Kong Stock Exchange)
Recent
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3.02
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div
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ROIC.AI
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- Shanghai Bio-heart Biological Technology Co., Ltd. operates as an innovative interventional cardiovascular device company based in Shanghai, China. The company develops and manufactures advanced medical devices focusing primarily on fully bioresorbable scaffolds (BRS) and renal denervation (RDN) systems. Its core products include the Bioheart® BRS system, a temporary scaffold used in percutaneous coronary intervention procedures for coronary artery disease, and the Iberis® multi-electrode RDN system designed for the treatment of uncontrolled and resistant hypertension. Additionally, Shanghai Bio-heart develops a sirolimus drug-coated balloon (DCB) catheter primarily aimed at treating in-stent restenosis. The company’s products address unmet medical needs in coronary artery disease, peripheral artery disease, and hypertension across China and multiple international markets including Europe and Asia. Founded in 2011 and headquartered in Shanghai’s Zhangjiang Hi-Tech Park Medical Device Industrial Park, the company has secured over 70 registered patents and holds CE Marking and multiple registration certificates for its products abroad. Key recent developments include the February 2025 regulatory approval from China's National Medical Products Administration (NMPA) for the Iberis® RDN system for the adjunct treatment of resistant hypertension and drug intolerant patients. In 2024, clinical trials of Iberis® demonstrated successful primary endpoints, and the Bioheart® BRS product completed several phases of clinical follow-ups preparing for an expected market approval in 2026. The company also participates as a major investor in technology and medical research partnerships with a RMB54.3 million capital contribution, reinforcing its commitment to innovation and pipeline expansion. Shanghai Bio-heart continues to strategically advance its clinical product development and commercialization efforts while expanding its manufacturing and sales capabilities. The company aims to leverage its first-mover advantage in China’s BRS and RDN markets and broaden its global presence through increased sales efforts, research and development enhancements, and selective external partnerships and acquisitions. Shanghai Bio-heart remains focused on becoming a leading global chronic disease management medical device platform in the interventional cardiovascular field. This description covers the company's comprehensive product range, key markets, recent regulatory and clinical progress, strategic partnerships, and its positioning within the medical device industry context as of late 2025.