Clinical development

Clinical roadmap

A rigorous approach centered on patient safety and clinical evidence.

Key milestones

Our provisional clinical development timeline.

From November 2026

Preclinical studies

Bench tests and preclinical studies to validate the safety and performance of the device.

2027 to 2028

Human clinical trials

A pilot study followed by a pivotal study in vascular centers of excellence.

2028 to 2029

Regulatory certifications

CE marking and FDA authorization processes.

Target 2029

Launch

First deployments to vascular surgeons.

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