Conavi Medical Corp. remains on track to submit its 510(k) application to the U.S. FDA in calendar Q3 2025 for their Novasight Hybrid™ system. Recent academic publications highlight the importance of intravascular imaging. A $20 million financing completed in April supports the anticipated U.S. launch in the first half of 2026.

Successful validation testing of Novasight Hybrid™ system with key opinion leaders was completed in July 2025. The system meets key customer specifications and is competitive with stand-alone IVUS and OCT solutions. The Company plans to submit its 510(k) application to the U.S. FDA in Q3 2025, with an expected U.S. launch in H1 2026.

Conavi is advancing preparations to transition the Novasight system from development to manufacturing in time for the U.S. launch in H1 2026. A recent publication in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) highlighted the system’s potential for guiding complex coronary interventions.

In fiscal Q3 2025, Conavi recorded revenue of $63,000, with operating expenses of $4.7 million. The net loss for the quarter was $3.6 million. As of June 30, 2025, cash and cash equivalents were $11.3 million, up from $0.4 million in September 2024. Research & development expenses decreased as the next-generation system nears FDA submission.

A $20 million financing was completed in April 2025, providing resources for regulatory submission, production transfer, and U.S. commercial launch. Conavi’s Novasight Hybrid™ System combines IVUS and OCT for coronary artery imaging and has regulatory clearance in the U.S., Canada, China, and Japan. Visit conavi.com for more information.

Read more at GlobeNewswire: Conavi Medical Reports Fiscal Q3 2025 Interim Results and