Conavi Medical Reports Fiscal Q3 2025 Interim Results and Operational Highlights

Executive Summary

• Conavi Medical reported financial results for the fiscal quarter ended June 30, 2025, showing a reduced net loss of $3.6 million ($0.05 per share) compared to $13.0 million in the prior year period, driven by lower R&D expenses as the next-generation Novasight system nears FDA submission.
• The company confirmed that validation testing with key opinion leaders was successful, confirming the next-generation Novasight system meets customer specifications for usability and imaging performance.
• The U.S. FDA 510(k) submission remains on track for calendar Q3 2025, with an anticipated U.S. commercial launch in the first half of calendar 2026.

Key Details

• Revenue: $63,000 for Q3 FY 2025, compared to $401,000 in Q3 FY 2024.
• Operating Expenses: $4.7 million for Q3 FY 2025, down from $8.8 million in Q3 FY 2024.
• Net Loss: $3.6 million ($0.05 per common share) for Q3 FY 2025, compared to $13.0 million ($2.12 per common share) in Q3 FY 2024.
• R&D Expenses: $3.2 million for Q3 FY 2025, down from $6.3 million in Q3 FY 2024.
• Cash Position: $11.3 million in cash and cash equivalents as of June 30, 2025, up from $0.4 million as of September 30, 2024.
• Validation Testing: Pre-clinical animal experiments conducted in July 2025 with leading interventional cardiologists confirmed the next-generation Novasight meets key specifications for usability, imaging performance, and workflow integration.
• Regulatory Status: 510(k) application submission to the U.S. FDA is on track for calendar Q3 2025.
• Production: Transfer of next-generation Novasight from development to manufacturing is underway, expected to be completed to coincide with the planned U.S. launch in H1 2026.
• Financing: A $20 million equity offering was completed in April 2025, providing resources for regulatory submission, production transfer, and U.S. launch preparation.
• Commission Payments: In connection with the $20M offering, the company paid a cash commission of $1,034,657.75 and issued 2,408,350 compensation options to Bloom Burton Securities Inc., plus 77,700 options to Raymond James Ltd. and 35,000 options to Research Capital Corporation.
• Publications: A case study highlighting hybrid IVUS/OCT imaging was published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) in July 2025.

Notable Quotes

• “Fiscal Q3 was an important quarter as we completed validation testing with leading interventional cardiologists, giving us confidence that our next generation Novasight™ is designed to be a best-in-class product,” said Thomas Looby, CEO of Conavi Medical. “We remain on track to submit our 510(k) application to the U.S. FDA in calendar Q3 2025, a key milestone that positions us for an anticipated U.S. launch in the first half of calendar 2026. Importantly, the $20 million financing completed in April strengthens our position as we work towards these key milestones.”