The Myonex Solution
To protect study timelines and maintain full operational control, Myonex implemented a dual-path clinical labeling and distribution strategy, enabling parallel supply execution across both regions.
Rather than relying solely on a sequential workflow, operations were designed to run independently in the US and EU where needed, removing critical dependencies and accelerating overall readiness.
The ultrasound resonator, a component of the Sonocloud-9 system is managed as an Investigational Medicinal Product (IMP). Supplied from the United States and stored at +2/+8°C, it requires two dedicated supply streams. In the US, Myonex performs primary and secondary labeling at its Horsham facility, managing both single-label printing and application before direct distribution to clinical sites nationwide. In parallel, the EU pathway involves booklet labeling at Myonex Le Haillan (France), followed by distribution across 10 European countries.
Carboplatin, the second IMP, is supplied from an EU country and stored at +15/+25°C. Labeling operations for both regions are performed at Myonex Le Haillan (France). From there, distribution flows are split: EU sites are supplied with the booklet-labeled products directly from Le Haillan, while batches intended for the US, with single-label formats, are shipped to Horsham for final on-demand distribution to sites.
This structure ensured simultaneous readiness across regions, while avoiding delays associated with sequential models for certain products. In this case, it eliminates the need for import licenses in some cases, reduces transport complexity and associated costs, and minimizes the risk of temperature excursions by limiting unnecessary product movement.
In addition, Myonex coordinates the Just-in-Time labeling and distribution of the blood brain barrier-opening device, SonoCloud-9®, the implantation kits and connectors, alongside drug supply. With no temperature-control constraints, these components were aligned with drug distribution timelines to ensure full operational readiness at site level.
Execution is driven by close, continuous coordination between Myonex teams in the US and France, with global study oversight by a dedicated Global Project Lead and local project management at each Myonex facility, ensuring alignment, compliance, and full control over timelines.