Singapore-based Biosensors International (SGX:B20) won FDA approval to launch a U.S. clinical trial of its BioFreedom drug-eluting stents, the company announced today.
U.S. regulators granted Biosensors investigational device exemption to conduct a 100-patient clinical examining the safety and efficacy of the BioFreedom stent, which is the 1st of its kind to use the novel Biolimus A9 drug.
"IDE approval for the BioFreedom U.S. trial represents a major milestone for the company because it is 1st first U.S.-based clinical study of a stent," Biosensors’ CEO Dr. Jack Wang said in prepared remarks. "The U.S. is the largest national market for medical devices. We look forward to introducing our unique and ground-breaking interventional cardiology products there."
Biosensors hopes to use data from the study to support a future pivotal trial in the U.S. in pursuit of FDA approval for the BioFreedom stent, a polymer-free device that won CE Mark approval from European regulators in January 2013.
Biosensors has previously pitted its device against Boston Scientific‘s (NYSE:BSX) Taxus Liberté stent, with clinical results finding that the Biosensors device showed improved late lumen loss compared with Taxus Liberté, with similar rates of major adverse cardiac events.
