CE Mark Readiness Profusa is actively progressing the Lumee Oxygen Platform toward CE Mark readiness with GMED, indicating a regulatory path and potential acceptance for European healthcare markets. This suggests sales opportunities in EU regions once approved, particularly for tissue oxygen monitoring in PAD, chronic wounds, and reconstructive surgery.

Clinical Expansion The Lumee Oxygen Platform targets tissue oxygen monitoring across multiple applications such as peripheral artery disease, chronic wounds, and post-surgical healing. There is potential to expand to additional indications where real-time biosensor data can guide treatment decisions, creating cross-selling opportunities with vascular, wound care, and surgical departments.

Strategic Partnerships Management has initiated a board-led process to evaluate strategic alternatives, including partnerships and commercial arrangements. This creates openings for distributors, healthcare technology integrators, and strategic alliances to scale sales, integrate with existing diagnostic workflows, and accelerate market adoption.

Nasdaq Momentum Recent Nasdaq listings activity and a focus on near-term commercial milestones signal ongoing investor support and credibility. This environment can attract hospital systems and buyers seeking proven digital health platforms with backing and a clear regulatory and governance path.

Global Market Readiness With plans to transfer to Nasdaq Capital Market and a European CE mark process underway, Profusa is signaling readiness to engage multinational healthcare buyers. This supports multi-region sales strategies, channel investments, and pilot programs in hospitals and clinics seeking real-time, actionable biosensor data.