Commercial Readiness

Galaxy is actively scaling its operational and commercial infrastructure in preparation for anticipated market approvals.

Manufacturing capacity is being expanded to support future demand, supported by ongoing investments in production readiness, quality systems, and supply chain capabilities.

In parallel, Galaxy has initiated commercial activity in select eligible markets, reinforcing its readiness to support broader commercialization as approvals are achieved.

Regulatory Momentum

Galaxy continues to advance toward key regulatory milestones across major global markets.

The Company has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA), marking a major milestone in Galaxy’s regulatory pathway.

In parallel, CE Mark activities remain on track as Galaxy continues to progress toward regulatory clearance in Europe.