Conavi Medical Secures FDA 510(k) Clearance for Hybrid IVUS-OCT System, Advancing U.S. Commercialization
核心洞察
Conavi Medical received U.S. FDA 510(k) clearance on April 20, 2026, for its next-generation Novasight Hybrid (搜索) intravascular imaging system combining IVUS and OCT in a single platform.
The company closed a $10 million public offering on August 12, 2026, to fund a targeted U.S. market release expected in the second half of 2026.
A peer-reviewed JSCAI case report demonstrated the system's utility in contrast-sparing management of eruptive calcified nodules (搜索) in a patient with impaired renal function.
Conavi Medical Corp. (搜索) (TSXV: CNVI) (OTCQB: CNVIF), a commercial-stage medical device company focused on imaging technologies for minimally invasive cardiovascular procedures, has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation Novasight Hybrid (搜索) intravascular imaging system. The clearance, received on April 20, 2026, positions the company to advance commercialization of a platform that combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) for simultaneous and co-registered imaging of coronary arteries within a single workflow.
"Fiscal Q3 was an important quarter for Conavi with FDA 510(k) clearance for our next-generation hybrid IVUS-OCT system," said Thomas Looby, President and Chief Executive Officer of Conavi Medical. "FDA clearance was a major milestone for the Company and allows us to move forward with commercialization in the U.S. We believe there is a real clinical need for a system that gives physicians the benefits of both IVUS and OCT in a single platform."
Regulatory Milestone and Commercialization Strategy
The FDA 510(k) clearance marks a pivotal regulatory achievement for Conavi's patented Novasight Hybrid (搜索) platform. Following clearance, the company has focused on completing transfer to production and preparing for a targeted market release at U.S. hospitals in calendar H2 2026. Commercial readiness activities include manufacturing readiness, reliability studies, early inventory build, and finalization of production transfer documentation.
"With the subsequent completion of our $10 million financing, we are now focused on completing the transfer to production and expect our first U.S. clinical placement in H2 2026," Looby added.
Clinical Evidence Supporting Hybrid Imaging
On July 8, 2026, subsequent to quarter end, Conavi announced the publication of a case report in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) titled "Versatility of Hybrid OCT and IVUS Imaging Enhances Contrast-Sparing Management of Eruptive Calcified Nodules (搜索)."
The case report featured Conavi's hybrid IVUS-OCT imaging system in a complex coronary procedure involving a patient with impaired renal function. It demonstrated how the complementary information provided by IVUS and OCT supported lesion assessment, treatment planning, stent optimization, and management of contrast use. The authors concluded that hybrid IVUS-OCT imaging may play an important role in patients with challenging plaque morphology, particularly in the setting of chronic kidney disease (搜索).
"The case reports published to date, with additional publications expected, add to the clinical evidence supporting hybrid imaging and demonstrate how access to both modalities can support physician decision-making in complex coronary procedures," Looby said.
Financial Position and Funding
Conavi reported a net loss of $6.3 million for Fiscal Q3 2026, compared to $3.6 million in the prior-year period, reflecting continued investment in research and development activities of $4.4 million, up from $3.2 million a year earlier. Total operating expenses were $6.5 million, compared to $4.7 million in Fiscal Q3 2025, with the increase primarily driven by higher R&D spending associated with Novasight 3.0 and transfer-to-production activities.
Cash and cash equivalents stood at $0.9 million as of June 30, 2026, compared to $5.8 million as of September 30, 2025. On August 12, 2026, subsequent to quarter end, the company closed a public offering for aggregate gross proceeds of $10 million, which it intends to use to support a targeted market release of its Hybrid IVUS-OCT system in the United States, as well as for working capital and general corporate purposes.
On June 29, 2026, Conavi received a $1.25 million milestone payment from the Province of Ontario through the Life Sciences Scale-Up Fund (LSSUF), triggered by the company's achievement of U.S. FDA 510(k) clearance. Including this payment, Conavi has received $1.75 million under the program to date and remains eligible for additional funding under an agreement providing for up to $2.5 million based on specified milestones.
Outlook
With FDA 510(k) clearance secured and the $10 million financing completed, Conavi is focused on executing its U.S. commercialization strategy. Near-term priorities include completing transfer to production, building initial inventory, initiating a targeted market release at U.S. hospitals, and continuing to build clinical evidence supporting adoption of hybrid IVUS-OCT imaging.