Core Insights - Conavi Medical Corp. reported its financial results for the fiscal quarter ended June 30, 2025, highlighting significant developments in its product pipeline and financial position [1][11]. Business Highlights - The company completed successful validation testing of its next-generation Novasight™ system with leading interventional cardiologists, confirming its competitiveness with existing IVUS and OCT solutions [2][3]. - A $20 million financing round completed in April 2025 strengthens the company's balance sheet, providing resources for regulatory submission and production transition [6][8]. Regulatory and Production Milestones - Conavi is on track to submit its 510(k) application to the U.S. FDA in Q3 2025, which is crucial for its planned U.S. launch in the first half of 2026 [4][10]. - The transition of the Novasight system from development to manufacturing is underway, expected to align with the U.S. launch timeline [4]. Financial Performance - For Q3 FY 2025, the company recorded revenue of CAD 63,000, a decrease from CAD 401,000 in the same period the previous year [11]. - Operating expenses were CAD 4.7 million, down from CAD 8.8 million year-over-year, leading to a reduced operating loss of CAD 4.6 million compared to CAD 8.9 million in Q3 FY 2024 [12]. - The net loss for Q3 FY 2025 was CAD 3.6 million, or CAD 0.05 per share, significantly improved from a net loss of CAD 13.0 million, or CAD 2.12 per share, in the prior year [13]. Market Context - A publication in the Journal of the American College of Cardiology emphasizes the growing importance of intravascular imaging in treating complex coronary artery disease, indicating a favorable market environment for Conavi's hybrid imaging technology [2][5].
Conavi Medical Reports Fiscal Q3 2025 Interim Results and Operational Highlights
Globenewswire·2025-08-29 11:00