Conavi Medical Reports Fiscal Third Quarter 2026 Results and Operational Highlights

GlobeNewswire | Conavi Medical Corp.
Today at 12:03pm UTC
  • Net loss for Fiscal Q3 2026 was $6.3 million (Fiscal Q3 2025 - $3.6 million) reflecting continued investment in research and development activities of $4.4 million (Fiscal Q3 2025 - $3.2 million) 
  • Ended Fiscal Q3 2026 with $0.9M in cash and cash equivalents (Fiscal Q4 2025 - $5.8 million) and on August 12, 2026 closed $10 million public offering
  • Received $1.25 Million Ontario Life Sciences Scale-Up Fund Milestone Payment
  • Achieved U.S. FDA 510(k) Clearance for Next-Generation Hybrid IVUS-OCT Imaging System
  • Added to Clinical Evidence Supporting Hybrid IVUS-OCT Imaging

TORONTO, Aug. 27, 2026 (GLOBE NEWSWIRE) --  Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage 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 June 30, 2026 (“Fiscal Q3 2026”).

“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. 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. 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.”

Fiscal Q3 2026 Financial Highlights
All amounts are in Canadian dollars unless otherwise noted.

Net loss for Fiscal Q3 2026 was $6.3 million, compared to a net loss of $3.6 million in the prior-year period. For the nine months ended June 30, 2026, net loss was $13.8 million compared to $13.7 million in the prior-year period.

Licensing and R&D services revenue for Fiscal Q3 2026 was $0.1 million compared to $0.1 million in the prior-year period. For the nine months ended June 30, 2026, total revenue was $0.5 million compared to $8.8 million in the prior-year period. The prior-year period included milestone revenue under the Company’s technology transfer and licensing agreement with East Ocean Medical that did not recur in Fiscal 2026.

Total operating expenses for Fiscal Q3 2026 were $6.5 million compared to $4.7 million in Fiscal Q3 2025. The increase primarily reflected higher research and development spending associated with Novasight 3.0 and transfer-to-production activities, as well as higher general and administrative expenses. Research and development expenses were $4.4 million compared to $3.2 million in the prior-year period.

Cash and cash equivalents were $0.9 million as of June 30, 2026, compared to $5.8 million as of September 30, 2025. Subsequent to quarter end, the Company completed the $10 million public offering described below.

For additional information regarding the Company’s financial performance, including management’s discussion and analysis, readers are encouraged to review Conavi Medical’s filings on SEDAR+ and on the Company’s website at www.conavi.com.

Fiscal Q3 2026 Business and Operational Highlights
FDA 510(k) Clearance of Next-Generation Hybrid Imaging System
On April 20, 2026, Conavi received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its next-generation Novasight Hybrid™ intravascular imaging system. The system combines intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) to enable simultaneous and co-registered imaging of coronary arteries within a single workflow.

Following clearance, Conavi 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.

$1.25 Million Ontario Life Sciences Scale-Up Fund Milestone Payment
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”). The payment was 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 to receive additional funding under the agreement, which provides for up to $2.5 million based on the achievement of specified milestones. Funding under the program is intended to support commercialization initiatives, manufacturing scale-up and other eligible costs associated with the launch of Conavi’s hybrid imaging system.

Peer-Reviewed Publication Adds to Clinical Evidence Supporting Hybrid IVUS-OCT 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.”

The case report featured Conavi’s hybrid IVUS-OCT imaging system in a complex coronary procedure involving a patient with impaired renal function and 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. Management believes the publication adds to the growing body of clinical evidence demonstrating the potential utility of having both IVUS and OCT available through a single hybrid imaging platform.

Closed $10 Million Public Offering to Support U.S. Commercialization
On August 12, 2026, subsequent to quarter end, Conavi closed its previously announced public offering for aggregate gross proceeds of $10 million. The Company intends to use the net proceeds 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. 

Outlook
With FDA 510(k) clearance secured and the $10 million financing completed subsequent to quarter end, 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.

About Conavi Medical
Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ platform combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single system, enabling simultaneous and co-registered imaging of coronary arteries. Conavi has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation hybrid intravascular imaging system and is advancing preparations for commercialization in the United States. For more information, visit conavi.com.

Notice on forward-looking statements
This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the commercialization and commercial launch of Conavi's hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging, the potential utility of hybrid IVUS-OCT imaging across a range of complex coronary procedures, and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company's profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

CONTACT:
Chief Financial Officer: Mark Quick, 416-483-0100
Investors: Christina Cameron, 416-483-0100 ext.121, IR@conavi.com


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