BA9 clinical trial

Biosensors, unlike most of its competitors, is a drug-eluting stent (DES) manufacturer that has designed and developed its own proprietory drug, specifically for use on a coronary stent. Clinical trials were carried out in healthy volunteers to highlight the safety profile of the Biolimus A9™ drug (BA9™).

These clinical trials have shown our commitment to using pioneering technology to deliver better patient outcomes and were instrumental in deciding the optimal use of BA9™ as part of the stent system.

Phase 1 Single Ascending Dose trial N=28
Design: Randomized, double blind, placebo controlled study of BA9™ with a 30 day follow-up.

Primary Endpoint: Safety, tolerability and dose dependant pharmacokinetics (PK).

Phase 1 Multiple Ascending Dose N=19
Design: Randomized, double blind, placebo controlled study of BA9™ with a 30 day follow-up.

Primary Endpoint: Safety, tolerability and dose dependant pharmacokinetics (PK).


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Biosensors’ interventional cardiology products, including BioMatrix Flex™, BioMatrix Flex™BTK, BioMatrix NeoFlex™, BioMatrix™, Axxess™, BioFreedom™, Chroma™, BioStream™, BioPath™, Gazelle™, Juno™, S-Stent™, Powerline™, Quadrature Link™ and MultiPleat™, are not available for sale in the United States and certain other countries. All other trademarks are the property of their respective owners.

BioMatrix Flex, BioMatrix NeoFlex, BioMatrix, Axxess, BioFreedom, Chroma, BioStream, BioPath, Gazelle, Juno, S-Stent, Powerline, Quadrature Link and MultiPleat are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and certain other countries. All cited trademarks are the property of their respective owners.