Strong DREAM Study Results
The DREAM U.S. pivotal study achieved its efficacy endpoints with a strong safety profile, demonstrating AHI response rates of 63.5% on an ITT basis and 66.4% on a modified ITT basis, with a p-value of 0.002.
Regulatory Progress and Anticipated FDA Approval
The company completed the fourth and final module in its modular PMA submission, anticipating FDA approval in Q1 2025.
Significant Capital Raise
Raised EUR 24.6 million in new capital from a single U.S. healthcare dedicated fund, extending cash runway to mid-2026.
Commercial Expansion in the U.S.
Strengthened U.S. presence with the hiring of key executive roles, and planning a commercial organization of approximately 50 people by the time of launch.
Strong Market Performance in Germany
Achieved a 25% overall market share in Germany only 24 months after launch, serving as a proxy for U.S. adoption trajectory.