U.S. and European Class 1A Guidelines Reinforce Growing Adoption of Image-Guided PCI
Peer-Reviewed Publications Highlight Clinical Importance of Intravascular Imaging
Leadership Team Expanded to Support U.S. Commercial Launch and Operational Scale-Up
Company Advances Manufacturing, Conference Visibility, and Launch Readiness
TORONTO, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV:CNVI) (OTCQB:CNVIF) ("Conavi" or the "Company"), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today reported financial results and provided an operational update for the fiscal year ended September 30, 2025.
"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 of Conavi Medical. "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."
Fiscal 2025 Business and Operational HighlightsU.S. FDA 510(k) Submission CompletedIn September 2025, Conavi submitted its next-generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration for 510(k) clearance for coronary applications. The submission followed successful validation testing with leading interventional cardiologists and builds upon the regulatory foundation of Conavi's first-generation Novasight Hybrid™ system, which previously received FDA clearance.
Peer-Reviewed Publications Reinforce Importance of Image-Guided TherapyDuring fiscal 2025, multiple peer-reviewed academic publications highlighted the importance of intravascular imaging in guiding complex coronary interventions. These publications, including case studies featuring hybrid IVUS/OCT imaging, underscore growing clinical momentum behind image-guided PCI and further support the relevance of Conavi's dual-modality approach.
Participation at Leading Interventional Cardiology ConferencesConavi participated in key cardiovascular conferences during the year, including Transcatheter Cardiovascular Therapeutics (TCT) 2025, where the Company featured hybrid IVUS/OCT imaging technology and engaged with interventional cardiologists through educational and training sessions in advance of an anticipated commercial launch.
U.S. Institutional Financing and Non-Dilutive Funding In April 2025, Conavi completed an upsized public equity financing for gross proceeds of $20 million, led by U.S. institutional investors.
In addition, the Company entered into an agreement with the Province of Ontario under the Life Sciences Scale-Up Fund, providing eligibility for up to $2.5 million in non-dilutive funding to support commercialization activities.
Operational and Manufacturing Readiness Activities AdvanceThroughout fiscal 2025, Conavi advanced transfer-to-production efforts, refined manufacturing processes, and continued to build the operational and commercial infrastructure required to support a U.S. launch of the next-generation Novasight Hybrid™ system, pending FDA clearance.
OutlookWith U.S. and European clinical guidelines now recommending the use of IVUS or OCT to guide PCI in complex coronary interventions (Class IA), Conavi believes the intravascular imaging market is entering a new phase of adoption. As the only company offering a fully integrated hybrid IVUS/OCT imaging system with a single catheter, Conavi believes it is well positioned to address growing demand following anticipated FDA clearance and U.S. commercial launch.
Fiscal 2025 Financial HighlightsAll amounts are in Canadian dollars unless otherwise noted.
As previously reported, during fiscal 2025 the Company remained focused on advancing the next-generation Novasight Hybrid™ system through regulatory submission, manufacturing readiness, and commercialization planning. For the year ended September 30, 2025, ...
