US FDA 510(k) Submission Follows the Successful Validation Testing with KOLs FDA 510(k) Clearance Anticipated During H1 2026 and Company Preparing for US Commercial Launch following ClearanceCoronary Intravascular Imaging Market Expected to Grow to over $1 bil USD by 2028 TORONTO, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to ...

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].