Conavi Medical Reports Fiscal Year 2025 Results and Operational Highlights
Executive Summary
- Conavi Medical reported FY 2025 revenue of $9.1 M (up from $2.2 M YoY) and reduced its net loss to $20.5 M ($0.36 per share) versus $43.6 M ($7.08 per share) in FY 2024.
- Completed an upsized public equity financing raising $20 M of gross proceeds and secured eligibility for up to $2.5 M non‑dilutive funding from the Ontario Life Sciences Scale‑Up Fund.
- Submitted a 510(k) application to the U.S. FDA for the next‑generation Novasight Hybrid™ IVUS/OCT system, positioning the company for a U.S. commercial launch pending clearance.
Key Details
- Financial Highlights (CAD)
- Revenue: $9.1 M vs. $2.2 M FY 2024.
- Operating expenses: $22.5 M vs. $26.3 M FY 2024.
- Operating loss: $14.9 M vs. $26.2 M FY 2024.
- Net loss: $20.5 M ($0.36/share) vs. $43.6 M ($7.08/share) FY 2024.
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Cash & cash equivalents at year‑end: $5.8 M (up from $0.4 M).
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Financing Activity
- April 2025 upsized public equity offering – $20 M gross proceeds, led by U.S. institutional investors.
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Agreement with the Province of Ontario’s Life Sciences Scale‑Up Fund – eligibility for up to $2.5 M non‑dilutive funding to support commercialization.
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Regulatory Milestone
- September 2025: Submitted next‑generation Novasight Hybrid™ IVUS/OCT system to the U.S. FDA for 510(k) clearance (coronary applications).
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Builds on prior clearance of first‑generation Novasight Hybrid™ system.
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Clinical & Market Validation
- Multiple peer‑reviewed publications in FY 2025 highlighted the clinical importance of intravascular imaging and hybrid IVUS/OCT for complex PCI.
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Participation at major cardiology conferences (e.g., TCT 2025) with educational sessions and technology demonstrations.
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Operational & Manufacturing Readiness
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Advanced transfer‑to‑production activities, refined manufacturing processes, and expanded commercial infrastructure in preparation for U.S. launch pending FDA clearance.
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Leadership Updates
- Expanded leadership team to support U.S. commercial launch and operational scale‑up (specific roles not detailed).
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Stefano Picone concluded his role as Chief Strategy Officer on December 24 2025.
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Outlook & Guidance
- Anticipates strong market adoption following FDA clearance, driven by Class IA guideline recommendations for IVUS/OCT use in complex coronary interventions (U.S. and Europe).
- Expected completion of the previously announced public offering in January 2026.
Notable Quotes
- “Fiscal 2025 was a transformational year for Conavi as we executed across regulatory, clinical, financial, and operational milestones,” – Thomas Looby, President & CEO.
Materiality Assessment: Material – Positive (significant improvement in financial performance, major financing, and key regulatory submission that materially affect the company’s outlook).