Reduction in Operating Expenses
Adjusted operating expenses were reduced by 45% compared to the prior year, reflecting increased efficiency and progress toward profitability.
Expansion of Gross Margin
Gross margin expanded to 75% compared to 73% in the prior year and 45% in the previous quarter, driven by increased manufacturing efficiencies.
Successful B2B2C Model Implementation
The B2B2C sales model demonstrated over 40% growth quarter-over-quarter and year-over-year in clinics in Europe.
FDA Engagement and Approval Path
Completed pre-PMA meeting with FDA and expect to complete PMA submission by the end of June, with positive feedback on additional analyses.
Progress in France
Reengagement and re-training of clinics in France, with plans to resume commercialization in the second half of the year.
Strong Cash Position
Ended the first quarter with cash and cash equivalents of $20 million, providing a runway for achieving FDA approval and profitability.