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Conavi Medical Corp. reports developments tied to its commercial-stage medical device business in cardiovascular imaging. The company designs, manufactures and markets technologies used to guide minimally invasive cardiovascular procedures, including a next-generation hybrid intravascular imaging system that combines intravascular ultrasound and optical coherence tomography in a single platform.
Recurring news themes include FDA 510(k) clearance, U.S. commercialization preparation, clinical and academic publications on hybrid IVUS-OCT imaging, operational and financial results, equity financing, non-dilutive funding agreements, leadership changes, investor conference participation and healthcare technology recognition.
Conavi Medical (OTCQB:CNVIF) reported Fiscal Q2 2026 results and major operational milestones for the quarter ended March 31, 2026.
Key points include FDA 510(k) clearance for its next‑generation hybrid IVUS-OCT imaging system, multiple 2026 industry awards, stable quarterly revenue, lower operating expenses, and a wider quarterly net loss.
Conavi Medical (OTCQB: CNVIF) received a 2026 TAG Innovation Award after securing FDA 510(k) clearance for its next‑generation hybrid intravascular imaging system. The platform combines IVUS and OCT in one workflow and positions the company to begin U.S. commercialization and broaden clinical adoption.
Conavi Medical (OTCQB:CNVIF) received FDA 510(k) clearance for its next-generation hybrid IVUS‑OCT intravascular imaging system on April 20, 2026. The device co-registers IVUS and OCT in a single workflow and positions Conavi for a limited U.S. commercial launch expected in H2 2026.
The company cites a >$4 billion global coronary intravascular imaging market with current IVUS/OCT penetration of 30–40%, and highlights streamlined workflow, lesion and stent analysis tools, and enhanced catheter deliverability as commercial features.
Conavi Medical (TSXV: CNVI; OTCQB: CNVIF) announced that CEO Thomas Looby will present and hold one-on-one meetings at the 2026 Bloom Burton & Co. Healthcare Investor Conference on April 21-22, 2026 in Toronto.
The CEO presentation is scheduled for April 22, 2026 at 9:30 a.m. ET at the Metro Toronto Convention Centre, with a live webcast and replay available via the company investor relations site for 30 days.
Conavi Medical (OTCQB: CNVIF) reported Fiscal Q1 2026 results for the quarter ended Dec 31, 2025, and highlighted operational developments. Key items: $12.0M public equity offering closed Jan 13, 2026; anticipated U.S. FDA 510(k) clearance in H1 2026; peer‑reviewed publication supporting hybrid IVUS‑OCT imaging; and termination of a $270,000 loan via issuance of 75,000 shares.
Financials: total revenue was $0.2M (prior $8.6M), operating loss $5.1M, net loss $2.7M ($0.04/share), and cash was $1.0M at quarter end before the subsequent $12.0M financing.
Conavi Medical (OTC:CNVIF) highlighted a peer‑reviewed Cardiovascular Research publication (Feb 2026) showing a histology‑trained hybrid IVUS‑OCT deep‑learning classifier outperformed single‑modality IVUS, OCT, and expert readers in plaque characterization. The company said this supports clinical and commercial value for its hybrid platform and noted it has submitted its next‑generation Novasight system to the FDA. The release also disclosed a 1,000,000 stock option grant to CFO Mark Quick at a $0.41 exercise price (VWAP on Feb 10, 2026), subject to vesting, expiry and regulatory approvals.
Conavi Medical (OTCQB: CNVIF) reported fiscal 2025 results for the year ended Sept 30, 2025 and provided an operational update ahead of a planned U.S. commercial launch. Key business highlights include a 510(k) submission for the next-generation Novasight Hybrid™ IVUS/OCT system, participation at major cardiology conferences, multiple peer-reviewed publications supporting image-guided PCI, and leadership hires to support U.S. scale-up.
Financially, revenue was $9.1M (FY2025) vs $2.2M (FY2024); net loss was $20.5M or $0.36/share; cash was $5.8M. The company completed a $20M public equity financing and is eligible for up to $2.5M in non-dilutive funding.
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.