Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
BioFreedom Ultra
- Development stage
- Unknown
- Lead developer
- Biosensors International
- Administration
- Intracoronary (implanted Via Percutaneous Coronary Intervention)
01
Overview
BioFreedom Ultra is a **polymer-free, carrier-free, drug-coated coronary stent system** featuring a thin cobalt-chromium strut (84 μm) coated abluminally (outward-facing side only) with **Biolimus A9 (INN: umirolimus)**, a highly lipophilic, semisynthetic sirolimus derivative developed specifically for coronary vascular applications. Biolimus A9 binds FKBP-12, which in turn inhibits the mammalian target of rapamycin (mTOR), arresting smooth muscle cell cycle progression from the G1 to S phase and thus inhibiting smooth muscle proliferation and restenosis after percutaneous coronary intervention (PCI). BioFreedom Ultra is designed for **high-bleeding-risk (HBR) patients** who can be treated safely with just 1-month dual antiplatelet therapy. Clinical trials have demonstrated noninferiority for safety compared to stainless steel DCS and superiority for efficacy versus bare metal stents, with a very low rate of definite/probable stent thrombosis at 1 year. The system is not available in the United States but received CE Mark in Europe in October 2020[1][2][3][4].
- Brand names
- BioFreedom Ultra
- Other names
- BioFreedom Ultra drug-coated stentBioFreedom Ultra DESBioFreedom Ultra CoCr DES
02
Targets
mTOR (Mammalian target of rapamycin kinase)
Beyond the preview
Go deeper on BioFreedom Ultra.
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Indications & development
Full profile accessExplore development by indication, patient population, and geography.
- Indications
- Development status
- Countries
Licensing & deals
Full profile accessTrace asset ownership, licensing agreements, and commercial partnerships.
- Partners
- Deal terms
- Milestones
Patents & exclusivity
Full profile accessExplore the patent landscape and regulatory exclusivity around an asset.
- Patents
- Expiration dates
- Exclusivity
Competitive landscape
Full profile accessCompare development programs by target, modality, and indication.
- Competing assets
- Targets
- Development stage
Research & analysis
Full profile accessConnect source evidence and development news to your research questions.
- Publications
- News
- Analysis
Bring the full picture into focus.
See how Gosset can support your research on BioFreedom Ultra.