Pre-Clinical Trials

As the only drug-eluting stent (DES) manufacturer to design and develop our own drug specifically for use on a coronary stent, we carried out pre-clinical trials in healthy volunteers to highlight the safety profile of Biolimus A9™ (BA9™).

These pre-clinical trials show 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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