Core Insights - Conavi Medical Corp. experienced a transformational fiscal year 2025, achieving significant regulatory, clinical, financial, and operational milestones, including the submission of its next-generation Novasight Hybrid™ system to the FDA and strengthening its balance sheet through U.S. institutional investments [2][3][6]. Business and Operational Highlights - The company completed its U.S. FDA 510(k) submission for the Novasight Hybrid™ IVUS/OCT system in September 2025, following successful validation testing with interventional cardiologists [3]. - Multiple peer-reviewed publications during fiscal 2025 emphasized the importance of intravascular imaging in complex coronary interventions, supporting Conavi's dual-modality imaging approach [4]. - Conavi participated in key cardiovascular conferences, such as TCT 2025, to showcase its hybrid imaging technology and engage with interventional cardiologists ahead of its commercial launch [5]. Financial Highlights - For the fiscal year ended September 30, 2025, Conavi reported total revenue of CAD 9.1 million, a significant increase from CAD 2.2 million in the previous year, primarily driven by licensing and milestone revenue from a technology transfer agreement in China [11]. - Operating expenses decreased to CAD 22.5 million from CAD 26.3 million in the prior year, resulting in an operating loss of CAD 14.9 million, an improvement from CAD 26.2 million in fiscal 2024 [12]. - The net loss for fiscal 2025 was CAD 20.5 million, or CAD 0.36 per share, compared to a net loss of CAD 43.6 million, or CAD 7.08 per share, in the previous year, attributed to a gain from the change in fair value of the company's warrant liability and lower operating expenses [13]. Funding and Financial Position - In April 2025, Conavi completed a public equity financing, raising CAD 20 million, and secured eligibility for up to CAD 2.5 million in non-dilutive funding from the Province of Ontario to support commercialization activities [6][14]. - As of September 30, 2025, the company reported cash and cash equivalents of CAD 5.8 million, a significant increase from CAD 0.4 million as of September 30, 2024 [14]. Market Outlook - With U.S. and European clinical guidelines now recommending the use of IVUS or OCT for guiding PCI in complex coronary interventions, Conavi is positioned to capitalize on the growing demand for intravascular imaging following anticipated FDA clearance and U.S. commercial launch [8].