Conavi Medical Reports Fiscal First Quarter 2026 Results and Operational Highlights

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]