Conavi Medical Reports Fiscal Q3 2025 Interim Results and Operational Highlights
US FDA 510(k) submission remains on track for calendar Q3 2025
Successful validation testing of Novasight Hybrid™ system with key opinion leaders
Recent academic publications underscore importance of intravascular imaging and potential of hybrid IVUS / OCT
$20 million financing completed in April strengthens balance sheet and supports anticipated U.S. launch
TORONTO, Aug. 29, 2025 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV:CNVI) (OTCQB:CNVIF) ("Conavi Medical" or the "Company"), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced its financial results for the fiscal quarter ended June 30, 2025.
"Fiscal Q3 was an important quarter as we completed validation testing with leading interventional cardiologists, giving us confidence that our next generation Novasight™ is designed to be a best-in-class product," said Thomas Looby, CEO of Conavi Medical. "We remain on track to submit our 510(k) application to the U.S. FDA in calendar Q3 2025, a key milestone that positions us for an anticipated U.S. launch in the first half of calendar 2026. Importantly, the $20 million financing completed in April strengthens our position as we work towards these key milestones."
A recent publication in the Journal of the American College of Cardiology (JACC) underscores the rising importance of intravascular imaging in the treatment of patients with complex coronary artery disease, a market that continues to grow as physicians increasingly rely on imaging to guide better outcomes. Combined with hands-on validation by experts using our system, these developments highlight the strong clinical and commercial momentum behind our hybrid IVUS / OCT technology and its potential to transform patient care.
Business Highlights:
Successful Validation Testing with Key Opinion Leaders: In July 2025, Conavi conducted two pre-clinical animal experiments with several leading interventional cardiologists, confirming that next generation Novasight meets key customer specifications for usability, imaging performance, and workflow integration. These studies validated market readiness and established that the system is competitive with best-in-class stand-alone IVUS and OCT solutions.
510(k) Regulatory Submission Remains on Track: The Company remains on track to submit its 510(k) application to the U.S. FDA in Q3 of calendar 2025, a critical milestone toward its planned U.S. launch in H1 calendar 2026.
Transfer to Production Underway: Conavi advanced preparations to transition next generation Novasight from development to manufacturing. Transfer to production is expected to be completed to coincide with the planned U.S. launch in H1 calendar 2026.
Peer-Reviewed JSCAI Publication: In July 2025, Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) published a case study with images from the first-generation Novasight system highlighting hybrid IVUS / OCT imaging as a breakthrough modality for guiding complex coronary interventions, further validating Conavi's unique clinical approach.
$20 Million Financing Strengthens Balance Sheet: In April ...
