Conavi Medical Submits Next Generation Novasight Hybrid Intravascular Imaging System to US FDA for 510(k) Clearance
Conavi Medical (OTCQB: CNVIF) has submitted its next-generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the FDA for 510(k) clearance. The system uniquely combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in a single integrated platform for coronary applications.
Key improvements include enhanced image quality, simplified user interface, improved cath lab workflow, and increased reliability. The company anticipates FDA clearance during H1 2026 and is preparing for US commercial launch. The coronary intravascular imaging market is projected to exceed $1 billion USD by 2028, supported by recent class IA guidelines in both US and Europe recommending IVUS or OCT for PCI procedural guidance.
Key improvements include enhanced image quality, simplified user interface, improved cath lab workflow, and increased reliability. The company anticipates FDA clearance during H1 2026 and is preparing for US commercial launch. The coronary intravascular imaging market is projected to exceed $1 billion USD by 2028, supported by recent class IA guidelines in both US and Europe recommending IVUS or OCT for PCI procedural guidance.
- Submission builds on previous FDA clearance of pilot system, potentially enabling efficient review
- Market expected to grow to over $1 billion USD by 2028
- Recent US and European guidelines recommend IVUS/OCT use, supporting market adoption
- Next-gen system offers dual-modality imaging advantages with enhanced features
- FDA clearance not expected until H1 2026, indicating significant wait time before commercialization
- US FDA 510(k) Submission Follows the Successful Validation Testing with KOLs
- FDA 510(k) Clearance Anticipated During H1 2026 and Company Preparing for US Commercial Launch following Clearance
- Coronary Intravascular Imaging Market Expected to Grow to over
$1 b il USD by 2028
TORONTO, Sept. 16, 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, announced that it has submitted its next generation Novasight Hybrid™ IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration (“FDA”) for 510(k) clearance for coronary applications.
“The submission marks an important milestone for Conavi as we advance toward bringing our next-generation IVUS/OCT imaging solution to the U.S. market,” said Tom Looby, Chief Executive Officer of Conavi Medical. “With our pilot system already cleared by the FDA, we feel that this submission leverages a strong regulatory foundation and may provide for an efficient review process. We believe the next-generation Novasight Hybrid™ system is well positioned to capitalize on the growing adoption of intravascular imaging, a category that has been shown to improve procedural outcomes during coronary interventions.”
Conavi’s proprietary hybrid intravascular imaging platform uniquely combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single integrated system. This dual-modality approach is designed to provide cardiologists with a comprehensive view of coronary arteries, potentially enabling more precise diagnosis and treatment of cardiovascular disease.
Key advancements in the next-generation Novasight Hybrid™ system include:
- Enhanced IVUS and OCT image quality
- Simplified user interface with added software features for improving ease of use
- System redesign to improve cath lab workflow including system setup and bedside control
- Design focus on reliability and robustness for routine clinical use
The intravascular imaging market continues to grow, driven by increasing global adoption of advanced imaging to optimize stent placement and improve clinical outcomes. Both the United States and Europe have recently adopted class IA guidelines recommending the use of IVUS or OCT for PCI procedural guidance. The European guidelines (ESC), released in August 2024, recommends that IVUS or OCT be used to guide PCIs in patients with complex lesions. The US guidelines (ACC/AHA/SCAI), released in February 2025, recommends that IVUS or OCT be used to guide stent implantation in patients with Acute Coronary Syndrome (ACS) in complex lesions
About Conavi Medical
Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid™ System has regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit conavi.com.
Cautionary Statement Regarding Forward-Looking Information
This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ System and expected FDA clearance and the commercial launch of next generation Novasight in the U.S.
These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.
Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.
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Contact:
Stefano Picone
Chief Financial Officer
(416) 483-0100
FAQ
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