TORONTO, May 28, 2026 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV:CNVI) (OTCQB:CNVIF) ("Conavi" or the "Company"), a 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 quarter ended March 31, 2026 ("Fiscal Q2 2026").
"Fiscal Q2 2026 marked a transformational period for Conavi highlighted by FDA 510(k) clearance of our next-generation Novasight™ Hybrid system, a milestone that positions the Company for commercial launch in the United States," said Thomas Looby, President and Chief Executive Officer of Conavi Medical. "In addition to this significant regulatory achievement, we were honoured to receive multiple industry awards recognizing the innovation and clinical potential of our hybrid IVUS-OCT technology. With commercialization activities advancing and financing initiatives underway to support our U.S. launch strategy, we believe Conavi is entering an exciting new phase of growth."
Fiscal Q2 2026 Business and Operational Highlights
FDA 510(k) Clearance of Next-Generation Hybrid Imaging SystemOn April 20, 2026, subsequent to quarter end, Conavi announced that it received U.S. Food and Drug Administration ("FDA") 510(k) clearance for its next-generation hybrid intravascular imaging system. The system integrates intravascular ultrasound ("IVUS") and optical coherence tomography ("OCT") into a single platform designed to provide simultaneous, co-registered imaging of coronary arteries within a unified workflow. The Company believes the clearance represents a major milestone for Conavi and positions the Company to initiate its targeted U.S. commercial launch expected in calendar H2 2026. The next-generation system includes enhancements designed to improve image quality, workflow efficiency, catheter deliverability, and overall ease of use for physicians performing image-guided coronary interventions.
Industry Awards Recognize Innovation and Technology LeadershipDuring and subsequent to the quarter, Conavi received multiple industry recognitions highlighting the Company's innovation in intravascular imaging technology.
Conavi was named a winner in the Medical Device category at the 2026 MedTech Breakthrough Awards, an independent program recognizing leading companies and technologies in the global health and medical technology market. The award recognized Conavi's next-generation hybrid IVUS-OCT imaging platform and its potential to improve physician workflow and clinical decision-making during coronary interventions.
Conavi was also awarded a 2026 TAG Innovation Award recognizing innovation and leadership in advancing healthcare technology following the Company's recent FDA 510(k) clearance announcement.
Management believes these recognitions provide important third-party validation of Conavi's technology and commercial opportunity within the growing intravascular imaging market.
Commercial Readiness Activities ContinueFollowing FDA clearance, Conavi is focused on ...
