Reported a net loss of $2,669,348 for the fiscal year ended December 31, 2025, compared to a $2,001,733 loss in 2024. Generated zero revenue for both 2025 and 2024 as commercial operations remain paused to focus on FDA Premarket Approval (PMA). Operating expenses increased to $2,255,474, driven by higher stock-based compensation. Working capital deficit stands at $3,837,757 as of December 31, 2025. The company is currently under an FDA Warning Letter issued in March 2025 regarding clinical study violations and is working on corrective actions.