November 10, 2021 — Biosensors International Group Ltd., a developer and manufacturer of innovative medical devices, announced the results of the BIO-RISE CHINA study, sponsored by its sister company, JW Medical Systems Ltd. (Shangdong, China). BIO-RISE CHINA is a multi-center, randomized controlled, superiority trial performed in 10 centers across China under the leadership of Prof. Han Yaling, principal investigator, and co-principal investigators, Dr. Guosheng Fu and Dr Yujie Zhou. This first-in-human study assessed the safety and efficacy of a Biolimus A9 (BA9) coated balloon (DCB) in patients with small vessel coronary artery disease undergoing PCI.
“The excellent results of the BioRise BA9 coated balloon [DCB] in this clinical study mean there is now a new therapeutic option for the treatment of small vessel disease in patients undergoing PCI," Han said.
212 patients were randomized between treatment with the BA9 coated balloon and plain old balloon angioplasty (POBA). The study met its primary end-point by demonstrating a highly statistically significant reduction of late lumen loss with the BA9 coated balloon compared to POBA at nine months (0.16±0.29 mm vs. 0.30±0.35 mm ∆ 0.14 mm; 95% CI -0.23 to -0.05; p = 0.001).
In addition, late lumen enlargement was three times more common with the BA9 coated balloon which was also associated with a trend towards improved clinical outcomes at one year.
This data is the first trial in a series of studies Biosensors and JWMS will conduct worldwide, including the REFORM trial (prospective, randomized, non-inferiority trial to determine the safety and efficacy of the BA9 drug coated balloon for the treatment of in-stent restenosis: first-in-man trial, a head-to-head to study comparing the BioRise DCB with the paclitaxel coated Sequent Please DCB across various centers in Europe.