Conavi Medical Submits Next-Generation Hybrid Imaging System to FDA as Clinical Guidelines Support Intravascular Imaging
核心洞察
Conavi Medical (搜索) submitted its next-generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. FDA for 510(k) clearance in September 2025, following successful validation testing with leading interventional cardiologists.
U.S. and European clinical guidelines now recommend the use of IVUS or OCT to guide percutaneous coronary intervention in complex coronary interventions with Class IA designation, supporting growing market adoption.
The company reported fiscal 2025 revenue of $9.1 million compared to $2.2 million in the prior year, while reducing operating losses from $26.2 million to $14.9 million as it transitions from development to commercialization.
Conavi Medical (搜索) Corp. has submitted its next-generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration (搜索) for 510(k) clearance, marking a pivotal step toward commercializing what the company describes as the first fully integrated hybrid imaging device for coronary interventions. The September 2025 submission follows successful validation testing with leading interventional cardiologists and builds upon the regulatory foundation of Conavi's first-generation system, which previously received FDA clearance.
The timing of the submission aligns with significant changes in clinical practice guidelines. U.S. and European clinical guidelines now recommend the use of intravascular ultrasound (IVUS) or optical coherence tomography (OCT) to guide percutaneous coronary intervention (PCI) in complex coronary interventions with Class IA designation, representing the highest level of clinical evidence and recommendation strength.
Regulatory and Clinical Momentum
"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 (搜索). "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."
During 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.
The company's Novasight Hybrid™ System (搜索) combines intravascular ultrasound and optical coherence tomography into a single device, enabling simultaneous and co-registered imaging of coronary arteries (搜索). Conavi positions itself as the only company offering a fully integrated hybrid IVUS/OCT imaging system with a single catheter.
Financial Performance and Funding
For the fiscal year ended September 30, 2025, Conavi recorded total revenue of $9.1 million, compared to $2.2 million in the prior year. Revenue during fiscal 2025 primarily reflects licensing and milestone revenue recognized under the company's technology transfer and licensing agreement in China, as well as limited product revenue from the first-generation system.
Operating expenses decreased to $22.5 million from $26.3 million in the prior year, resulting in an operating loss of $14.9 million compared to $26.2 million in fiscal 2024. The year-over-year improvement was primarily driven by lower research and development spending as the company progressed from intensive development activities toward regulatory submission, partially offset by commercialization and corporate costs.
The net loss for fiscal 2025 was $20.5 million, or $0.36 per common share, compared to a net loss of $43.6 million, or $7.08 per common share, in the prior year. The decrease in net loss was primarily attributable to a gain related to the change in fair value of the company's warrant liability, as well as lower operating expenses.
Strengthened Financial Position
In April 2025, Conavi completed an upsized public equity financing for gross proceeds of $20 million, led by U.S. institutional investors. The company also entered into an agreement with the Province of Ontario (搜索) under the Life Sciences Scale-Up Fund, providing eligibility for up to $2.5 million in non-dilutive funding to support commercialization activities.
As of September 30, 2025, Conavi reported cash and cash equivalents of $5.8 million, compared to $0.4 million as of September 30, 2024. The company has announced a proposed public offering expected to be completed in January 2026.
Commercial Preparation
Throughout 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 (搜索), pending FDA clearance.
The company participated in key cardiovascular conferences during the year, including Transcatheter Cardiovascular Therapeutics (TCT) 2025, where it featured hybrid IVUS/OCT imaging technology and engaged with interventional cardiologists through educational and training sessions in advance of an anticipated commercial launch.
Market Outlook
Conavi believes the intravascular imaging market is entering a new phase of adoption, supported by the Class IA clinical guideline recommendations. The Novasight Hybrid™ System (搜索) has regulatory clearance in the U.S., Canada, China, and Japan for its first-generation version, providing a foundation for the next-generation system's commercial prospects.
The company expects to address growing demand following anticipated FDA clearance and U.S. commercial launch, positioning its hybrid imaging approach as a differentiated solution in the interventional cardiology market.