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Conavi Medical (OTC:CNVIF) announced leadership changes and U.S. commercialization preparations on November 3, 2025. The company appointed Mark Quick as Chief Financial Officer to lead financial strategy and investor engagement, while current CFO Stefano Picone moves to a transitional Chief Strategy Officer role to support continuity during scale-up.
Conavi also submitted its next‑generation Novasight Hybrid IVUS/OCT intravascular imaging system to the U.S. FDA for 510(k) clearance and said it is building U.S. commercial infrastructure ahead of launch.
Conavi Medical (OTCQB: CNVIF) announced on October 29, 2025 an agreement with the Province of Ontario under the Life Sciences Scale-Up Fund to support the commercial launch of the next‑generation Novasight Hybrid system.
Under the arrangement Conavi is eligible to receive up to $2.5 million CAD over the project to cover up to one‑third of eligible project costs, subject to certain requirements. The funding is intended to support design and manufacturing activity for the dual‑modality intravascular imaging system that combines IVUS and OCT to guide coronary procedures.
Conavi Medical (OTCQB: CNVIF) will highlight its Novasight Hybrid™ intravascular imaging at TCT 2025 in San Francisco, Oct 25–28, 2025, with booth #2126.
The company will present clinical images from its first‑generation IVUS/OCT system and participate in physician‑led Intravascular Imaging & Training sessions on Oct 26–27. Conavi said the next‑generation Novasight Hybrid was submitted for FDA 510(k) clearance in September 2025. The first‑generation system previously received FDA 510(k) clearance, Health Canada approval, and was used at seven luminary cardiovascular hospitals in North America.
Conavi Medical (OTCQB: CNVIF) will present at the Planet MicroCap Showcase: TORONTO in partnership with MicroCapClub on Wednesday, October 22, 2025 at 9:30 AM EST at the Arcadian Loft in Downtown Toronto.
Tom Looby, Chief Executive Officer, will host the presentation and take questions. A live webcast will be available and all company webcasts will be archived on the event platform under the Agenda tab. Investors may register to attend and request 1x1 in-person meetings at the conference venue.
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.
Conavi Medical (OTCQB:CNVIF), a medical device company specializing in cardiovascular imaging technology, reported its fiscal Q3 2025 results and provided key operational updates. The company remains on track to submit its 510(k) application for the Novasight Hybrid™ system to the FDA in Q3 2025, targeting a commercial launch in H1 2026.
Financial highlights include a significant reduction in operating loss to $4.6M from $8.9M year-over-year, and improved cash position of $11.3M following a $20M equity offering completed in April. Revenue was $63,000, down from $401,000 in the prior year, reflecting the company's focus on next-generation product development.
Operational achievements include successful validation testing with leading cardiologists and a notable publication in JSCAI validating their hybrid IVUS/OCT imaging approach.
Conavi Medical (OTCQB: CNVIF) announced the publication of a significant case report in the Journal of the Society for Cardiovascular Angiography & Interventions featuring their Novasight™ Hybrid IVUS-OCT System. The case report demonstrates how the system's dual imaging capabilities led to superior diagnosis and treatment in a complex coronary case.
The study highlighted how the system correctly identified a plaque rupture that was initially misdiagnosed as calcification through traditional angiography. The technology combines high-resolution OCT imaging with IVUS anatomical reference points, enabling precise stent placement. CEO Thomas Looby confirmed the company's next-generation Novasight™ Hybrid System is on track for FDA 510(k) submission in Q3 2025.
Conavi Medical (OTCQB: CNVIF) highlights a significant study published in The American Journal of Cardiology regarding intracoronary imaging (ICI) during percutaneous coronary interventions (PCI). The study, analyzing over 1.8 million patient records, reveals that only 13.5% of patients received image-guided PCI by 2020, despite its proven benefits.
The company's Novasight Hybrid System, which uniquely combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in a single platform, addresses key adoption barriers identified in the study. The system provides co-registered imaging in real-time, streamlining workflow and reducing procedural complexity while supporting recent Class IA recommendations in the 2024 ESC and 2025 ACC/AHA guidelines for complex PCI cases.
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