Corporate Profile

China's leading interventional cardiovascular device company

Bioheart is a leading interventional cardiovascular device company in China, and locate in Shanghai Zhangjiang Hi-Tech Park Medical Device Industrial Park. Focused on two therapies, bioresorbable scaffolds (BRS) and renal denervation (RDN), addressing the unmet medical needs of Chinese patients for the treatment of coronary and peripheral artery diseases and uncontrolled hypertension.

Bioheart lease an area of about 3000 square meters, including around 1800 square meters of class 10,000 clean workshops and a full-project testing laboratory for related products. We have also established a quality management system which meets the ISO13485/YY0287 standard, and have gathered professionals in machinery, polymer, precision processing, and clinical medicine with extensive experience in product design, quality control, clinical verification, and market development.

Development path

Shanghai AngioCare Medical Technology Ltd. was established.

The product development of Iberis single-electrode denervation system was completed and passed the CFDA type inspection in December 2012;

AngioCare and Terumo, the leading Asian medical device company, reached a strategic partnership in December 2012.

Iberis single-electrode RDN system has been registered in the European Union and is the first product of its kind in Asia;

Launched BRS product research and development;

AngioCare launched Iberis multi-electrode RDN system product developme.

Shanghai Bio-heart Biological Technology Co., Ltd. was established;

Bioheart's BRS product received interim reports from animal experiments, which preliminarily prove the safety and effectiveness of the products.

BRS product obtained product registration type inspection report.

BRS product obtained the medical device clinical trial approval from the State Food and Drug Administration;

BRS product completed the first enrollment of FIM clinical trial;

AngioCare was awarded as Shanghai High-tech Enterprise;

Iberis multi-electrode RDN system has been registered in the European Union.

Bioheart BRS product passed the special approval application for innovative medical devices of the State Food and Drug Administration, and entered the special approval procedure "green channel";

BRS product obtained special fund subsidy for the development of strategic new industries from the Shanghai Development and Reform Commission;

Bioheart BRS product completed the 1 years follow-up of the FIM clinical trial;

Bioheart BRS product initiated the randomized controlled confirmatory clinical trial;

Iberis multi-electrode RDN system initiated FIM clinical trial in Japan.


Bioheart BRS product completed the 2 years follow-up of the FIM clinical trial.

Bioheart BRS product completed the 3 years follow-up of FIM clinical trial;

Bioheart BRS product completed the enrollment of the randomized controlled confirmatory clinical trial;

Bioheart BRS product initiated the single-arm confirmatory clinical trials;

AngioCare was evaluated as a pilot unit for patent affairs in Shanghai;

Iberis multi-electrode RDN system completed FIM clinical trial in Japan.

Bioheart lunched the development of Bioresorbable below-the-knee (BTK) artery drug-eluting stent system;

Bioheart lunched the development of BRS system with ultra-thin strut;

Bioheart lunched the development of Balloon Dilatation

Catheter, Noncompliant (high-pressure) balloon dilatation catheter and Impulse balloon dilatation catheter;

AngioCare was awarded as Shanghai High-tech Enterprise again.