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Conavi Medical Reports Fiscal Year 2025 Results and Operational Highlights
Next-Generation Novasight Hybrid™ System Submitted to U.S. FDA for 510(k) Clearance U.S....
About this update from Conavi Medical Corp.
[{"type":"text","content":"Conavi Medical Reports Fiscal Year 2025 Results and Operational Highlights\nNext-Generation Novasight Hybrid™ System Submitted to U.S. FDA for 510(k) Clearance U.S. and European Class 1A Guidelines Reinforce Growing Adoption of Image-Guided PCIPeer-Reviewed Publications Highlight Clinical Importance of Intravascular ImagingLeadership Team Expanded to Support U.S. Commercial Launch and Operational Scale-UpCompany Advances Manufacturing, Conference Visibility, and Launch Readiness TORONTO, Dec. 29, 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 guide minimally invasive cardiovascular procedures, today reported financial results and provided an operational update for the fiscal year ended September 30, 2025. “Fiscal 2025 was a transformational year for Conavi as we executed across regulatory, clinical, financial, and operational milestones,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “We strengthened our balance sheet with meaningful participation from U.S. institutional investors, submitted our next-generation Novasight Hybrid™ system to the FDA, expanded our leadership team, and continued to build a growing body of clinical and academic evidence supporting image-guided therapy. With U.S. and European Class 1A guideline support now in place for intravascular imaging, we believe the timing is right and that Conavi is uniquely positioned with the right device as we prepare for U.S. commercialization.” Fiscal 2025 Business and Operational HighlightsU.S. FDA 510(k) Submission CompletedIn September 2025, Conavi submitted its next-generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration for 510(k) clearance for coronary applications. The submission followed successful validation testing with leading interventional cardiologists and builds upon the regulatory foundation of Conavi’s first-generation Novasight Hybrid™ system, which previously received FDA clearance. Peer-Reviewed Publications Reinforce Importance of Image-Guided TherapyDuring fiscal 2025, multiple peer-reviewed academic publication...