Conavi submits Novasight imaging system to FDA

Mr. Tom Looby reports CONAVI MEDICAL SUBMITS NEXT GENERATION NOVASIGHT HYBRID INTRAVASCULAR IMAGING SYSTEM TO US FDA FOR 510(K) CLEARANCE Conavi Medical Corp. has submitted its next generation Novasight Hybrid IVUS/OCT intravascular imaging system to the United States Food and Drug Administration (FDA) for 510(k) clearance for coronary applications. "The submission marks an important milestone for Conavi as we advance toward bringing our next-generation IVUS/OCT imaging solution to the U.S. market," said Tom Looby, chief executive officer of Conavi Medical. "With our pilot system already cleared by the FDA, we feel that this submission leverages a strong regulatory foundation and may provide for an efficient review process. We believe the next-generation Novasight Hybrid system is well positioned to capitalize on the growing adoption of intravascular imaging, a category that has been shown to improve procedural outcomes during coronary interventions." Conavi's proprietary hybrid intravascular imaging platform uniquely combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single integrated system. This dual-modality approach is designed to provide cardiologists with a comprehensive view of coronary arteries, potentially enabling more precise diagnosis and treatment of cardiovascular disease. Key advancements in the next-generation Novasight Hybrid system include: Enhanced IVUS and OCT image quality; Simplified user interface with added software features for improving ease of use; System redesign to improve cath lab workflow including system setup and bedside control; Design focus on reliability and robustness for routine clinical use. The intravascular imaging market continues to grow, driven by increasing global adoption of advanced imaging to optimize stent placement and improve clinical outcomes. Both the United States and Europe have recently adopted Class IA guidelines recommending the use of IVUS or OCT for PCI procedural guidance. The European guidelines (ESC), released in August, 2024, recommends that IVUS or OCT be used to guide PCIs in patients with complex lesions. The U.S. guidelines (ACC/AHA/SCAI), released in February, 2025, recommends that IVUS (intravascular ultrasound) or OCT (optical coherence tomography) be used to guide stent implantation in patients with Acute Coronary Syndrome (ACS) in complex lesions About Conavi Medical Corp. Conavi Medical is focused on designing, manufacturing and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid system is the first to combine IVUS and OCT into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid system has regulatory clearance in the United States, Canada, China and Japan. We seek Safe Harbor.