Biosensors International Announces Results of the BIO-RISE CHINA Randomized Trial Assessing a Biolimus A9-Coated Balloon

November 6, 2021—Biosensors International Group, Ltd., a medical device manufacturer and subsidiary of Bluesail Medical Co., Ltd., announced the results of the BIO-RISE CHINA study, a multicenter, randomized controlled, superiority trial performed in 10 centers across China. The study assessed the safety and efficacy of the BioRise Biolimus A9 (BA9)–coated balloon compared to plain balloon angioplasty (POBA) in patients with small-vessel coronary artery disease. The results were presented in a late-breaking clinical trial session at TCT 2021, held in Orlando, Florida.

According to the company, the BioRise drug-coated balloon (DCB) was coated with BA9, which had previously demonstrated positive outcomes when used as a stent coating on Biosensors’ BioMatrix and BioFreedom families of coronary stents. BA9 is a highly lipophilic, antirestenotic drug developed for local drug delivery into vascular tissue. The BioRise DCB features a crystalline form of BA9, which allows rapid transfer of the drug into the vessel wall.

As stated in the announcement, the first-in-human study randomized 212 patients between treatment with the BA9-coated balloon and POBA. The study met its primary endpoint by demonstrating a highly statistically significant reduction of late lumen loss with the BA9-coated balloon compared to POBA at 9 months (0.16 ± 0.29 mm vs 0.30 ± 0.35 mm [a Δ of 0.14 mm]; 95% CI −0.23 to −0.05; P = .001). Late lumen enlargement was also three times more common with the BA9 DCB, which was associated with a trend toward improved clinical outcomes at 1 year.

Professor Yaling Han served as Principal Investigator of the study, along with Coprincipal Investigators, Drs. Guosheng Fu and Yujie Zhou. Prof. Han commented, “The excellent results of the BioRise BA9 DCB in this clinical study mean there is now a new therapeutic option for the treatment of small-vessel disease in patients undergoing percutaneous coronary intervention.”