Shanghai Bio-heart Biological Technology Co., Ltd. announced that the RCT of the Company's Bioheart® bioresorbable coronary rapamycin-eluting scaffold in patients with coronary heart disease ("BIOHEART-II") has recently achieved its pre-set primary clinical endpoint. BIOHEART-II is a forward-looking, multi-center, and randomized controlled clinical study with the control group receiving treatment using Abbott's marketed Xience everolimus-eluting coronary scaffold. The study aims to evaluate the safety and efficacy of the Company's Bioheart ® bioabsorbable coronary rapamycin-eluting scaffold in coronary revascularization.

A total of 431 subjects was enrolled in the study. The study showed that the primary clinical endpoint of in-segment late lumen loss at 12 months after the procedures in the test group achieved the primary clinical endpoint of efficacy and was not inferior to that in the control group. In this study, the safety of patients using the Bioheart ® bioabsorbable coronary rapamycin-eluting scaffold was similar to that of patients using the control scaffold, with no increased risk of adverse events such as myocardial infarction and death, and no stent thrombosis events.

As of the date of this announcement, only two BRS products were commercialized in China, each of which was a first-generation BRS product with a strut thickness of over 150 m. Are one of only four domestic players in China with second-generation BRS products at clinical trial stage. Since completed the patient enrollment of the RCT earlier than the other competitors in China, Bioheart ® is expected to be the world's first second-generation BRS system receiving regulatory approval based on multi-center RCT results. Bioheart ® was recognized as an "innovative medical device" by the NMPA in February 2017 and is therefore eligible for an expedited approval process.

Looking ahead, the Company will carry on its ongoing clinical and registration application programs and will actively prepare for pre-commercialization to bring Bioheart® to the market. The Company will continue to strengthen its in-house research and development capabilities and bring innovation to clinical care.