Conavi loses $20.5-million in fiscal 2025

Executive Summary

• Conavi Medical reported fiscal year 2025 financial results, showing a significant reduction in net loss to $20.5 million (from $43.6 million in FY2024) and a revenue increase to $9.1 million, driven by licensing and milestone revenue.
• The company submitted its next-generation Novasight Hybrid IVUS/OCT system to the U.S. FDA for 510(k) clearance in September 2025, aiming for a U.S. commercial launch in January 2026.
• The company completed a $20 million public equity financing in April 2025 and secured eligibility for up to $2.5 million in non-dilutive funding from the Province of Ontario.

Key Details

• Financial Performance (FY ended Sept 30, 2025):
  • Total Revenue: $9.1 million CAD (up from $2.2 million in prior year).
  • Operating Expenses: $22.5 million CAD (down from $26.3 million).
  • Operating Loss: $14.9 million CAD (improved from $26.2 million).
  • Net Loss: $20.5 million CAD (or $0.36 per share), compared to a net loss of $43.6 million CAD ($7.08 per share) in FY2024.
  • Cash and Cash Equivalents: $5.8 million CAD (up from $400,000 CAD).
• Financing Activities:
  • Completed an upsized public equity financing in April 2025 for gross proceeds of $20 million CAD, led by U.S. institutional investors.
  • Entered into an agreement with the Province of Ontario for up to $2.5 million in non-dilutive funding under the Life Sciences Scale-Up Fund.
• Regulatory and Product Updates:
  • Submitted next-generation Novasight Hybrid IVUS/OCT system to the U.S. FDA for 510(k) clearance for coronary applications in September 2025.
  • The submission follows successful validation testing and builds on the regulatory foundation of the first-generation system, which previously received FDA clearance.
  • U.S. and European Class 1A guidelines now reinforce the adoption of image-guided PCI.
• Operational and Commercial Updates:
  • Leadership team expanded to support U.S. commercial launch and operational scale-up.
  • Advanced manufacturing transfer-to-production efforts and refined manufacturing processes.
  • Participated in key conferences including TCT 2025 to engage with interventional cardiologists.
  • Multiple peer-reviewed publications highlighted the clinical importance of intravascular imaging and hybrid IVUS/OCT approaches.
• Proposed Offering:
  • The previously announced proposed public offering of common shares and/or prefinanced common share purchase warrants is continuing.
  • The company expects the offering to be completed in January 2026.
• Management Changes:
  • Stefano Picone completed his transitional role as Chief Strategy Officer effective December 24, 2025.
• Early Warning Disclosure / Shareholder Activity:
  • Carlyle Services LLC transferred beneficial ownership of its securities to its affiliate, Ki Investments Europe Sarl, effective December 24, 2025.
  • Ki Investments now beneficially owns 21,750,180 common shares and warrants exercisable for 6,333,132 common shares.
  • This represents approximately 28.34% of issued and outstanding common shares (non-diluted) and 33.80% on a partially diluted basis.
  • Consideration paid was the U.S.-dollar equivalent of $13,385,061 CAD, based on market value as of November 14, 2025.

Notable Quotes

• "Fiscal 2025 was a transformational year for Conavi as we executed across regulatory, clinical, financial and operational milestones," said Thomas Looby, president and chief executive officer. "We strengthened our balance sheet with meaningful participation from U.S. institutional investors, submitted our next-generation Novasight Hybrid system to the FDA, expanded our leadership team, and continued to build a growing body of clinical and academic evidence supporting image-guided therapy."
• "With U.S. and European Class 1A guideline support now in place for intravascular imaging, we believe the timing is right and that Conavi is uniquely positioned with the right device as we prepare for U.S. commercialization."