Core Insights - Conavi Medical Corp. is nearing a significant milestone with the expected U.S. FDA 510(k) clearance of its Novasight Hybrid™ system in the first half of 2026, positioning the company for growth in the intravascular imaging market [2] Financial Highlights - Total revenue for Fiscal Q1 2026 was $0.2 million, a decrease from $8.6 million in the prior-year period, primarily due to the absence of milestone revenue from a development agreement [8] - Total operating expenses were $5.4 million, down from $6.8 million in Fiscal Q1 2025, reflecting reduced research and development spending [9] - The operating loss for the quarter was $5.1 million, compared to $0.3 million in the prior-year period, while the net loss was $2.7 million, or $0.04 per common share, compared to a net loss of $7.0 million, or $0.18 per common share, in Fiscal Q1 2025 [9] Operational Updates - The company successfully closed a $12 million public offering on January 13, 2026, issuing 26,666,670 common shares at a price of $0.45 per share, with proceeds aimed at supporting FDA clearance efforts and U.S. market release preparation [3] - A peer-reviewed publication highlighted the clinical value of the hybrid IVUS-OCT imaging technology, demonstrating its superiority in plaque characterization compared to single-modality imaging [4] - Conavi has entered into a termination agreement with MaRS Investment Accelerator Fund Inc. to terminate a $270,000 loan agreement, satisfying the debt through the issuance of 75,000 common shares [5] Future Outlook - The company anticipates FDA 510(k) clearance in the latter part of the first half of calendar 2026 and plans to initiate the U.S. market release of Novasight™ 3.0 in the third quarter of calendar 2026 [7] - Conavi will attend the LSI USA '26 conference from March 16–20, 2026, which gathers leading MedTech executives and investors [6]

Core Insights - The publication of new peer-reviewed research supports the clinical and commercial value of Conavi Medical's hybrid intravascular imaging platform, demonstrating its superiority in plaque characterization compared to single-modality analyses and human experts [1][2]. Group 1: Research Findings - The study analyzed IVUS-OCT images and matched histological sections from 10 cadaveric human hearts, showing that a histology-trained hybrid IVUS-OCT deep-learning classifier outperformed single-modality IVUS, single-modality OCT, and expert readers in plaque characterization [2]. - The research highlights the importance of comprehensive hybrid imaging systems in enhancing treatment planning for coronary interventions [2]. Group 2: Company Developments - Conavi Medical is advancing the development and commercialization of its next-generation hybrid IVUS-OCT imaging solutions, having submitted its Novasight imaging system to the U.S. FDA for regulatory clearance [4]. - The company has granted stock options to its Chief Financial Officer, Mark Quick, for a total of 1,000,000 common shares at an exercise price of $0.41 per share, as part of its long-term incentive program [5][6]. Group 3: Leadership and Expertise - The publication includes contributions from Dr. Brian Courtney, a pioneer in hybrid IVUS-OCT imaging, and co-authors from various regions, including Canada, Europe, and the USA, as well as AI researchers from Queen Mary University of London [3]. - The CEO of Conavi Medical, Tom Looby, emphasized the clinical value proposition of the technology platform and the significance of hybrid systems in the evolving field of image-guided coronary interventions [4]. Group 4: Company Overview - Conavi Medical focuses on designing, manufacturing, and marketing imaging technologies for minimally invasive cardiovascular procedures, with its Novasight Hybrid™ System being the first to combine IVUS and OCT into a single device [7]. - The first-generation Novasight Hybrid™ System has received 510(k) regulatory clearance in the U.S., Canada, China, and Japan [7].