Conavi Medical Reports Fiscal Q3 2025 Interim Results and Operational Highlights

US FDA 510(k) submission remains on track for calendar Q3 2025
Successful validation testing of Novasight Hybrid™ system with key opinion leaders
Recent academic publications underscore importance of intravascular imaging and potential of hybrid IVUS / OCT
$20 million financing completed in April strengthens balance sheet and supports anticipated U.S. launch

TORONTO, Aug. 29, 2025 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi Medical” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced its financial results for the fiscal quarter ended June 30, 2025.

“Fiscal Q3 was an important quarter as we completed validation testing with leading interventional cardiologists, giving us confidence that our next generation Novasight™ is designed to be a best-in-class product,” said Thomas Looby, CEO of Conavi Medical. “We remain on track to submit our 510(k) application to the U.S. FDA in calendar Q3 2025, a key milestone that positions us for an anticipated U.S. launch in the first half of calendar 2026. Importantly, the $20 million financing completed in April strengthens our position as we work towards these key milestones.”

A recent publication in the Journal of the American College of Cardiology (JACC) underscores the rising importance of intravascular imaging in the treatment of patients with complex coronary artery disease, a market that continues to grow as physicians increasingly rely on imaging to guide better outcomes. Combined with hands-on validation by experts using our system, these developments highlight the strong clinical and commercial momentum behind our hybrid IVUS / OCT technology and its potential to transform patient care.

Business Highlights:

Successful Validation Testing with Key Opinion Leaders: In July 2025, Conavi conducted two pre-clinical animal experiments with several leading interventional cardiologists, confirming that next generation Novasight meets key customer specifications for usability, imaging performance, and workflow integration. These studies validated market readiness and established that the system is competitive with best-in-class stand-alone IVUS and OCT solutions.

510(k) Regulatory Submission Remains on Track: The Company remains on track to submit its 510(k) application to the U.S. FDA in Q3 of calendar 2025, a critical milestone toward its planned U.S. launch in H1 calendar 2026.

Transfer to Production Underway: Conavi advanced preparations to transition next generation Novasight from development to manufacturing. Transfer to production is expected to be completed to coincide with the planned U.S. launch in H1 calendar 2026.

Peer-Reviewed JSCAI Publication: In July 2025, Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) published a case study with images from the first-generation Novasight system highlighting hybrid IVUS / OCT imaging as a breakthrough modality for guiding complex coronary interventions, further validating Conavi’s unique clinical approach.

$20 Million Financing Strengthens Balance Sheet: In April 2025, Conavi completed an upsized equity offering for gross proceeds of $20 million. Led by U.S. institutional investors, the financing provides resources to complete the regulatory submission, advance transfer to production, and prepare for anticipated U.S. commercial launch of Novasight.

Upcoming Targeted Milestones (calendar dates):

Q3 2025

Planned submission of next generation Novasight U.S. FDA 510(k) application.

Q4 2025

Publish additional whitepapers and case studies to drive awareness.

H1 2026

Expected FDA clearance and U.S. commercial launch of next generation Novasight.

Fiscal Q3 2025 Financial Results

All amounts are in Canadian dollars unless specified otherwise:

As previously reported, in the two preceding fiscal years and in FY Q2 2025, the Company focused on development of the next-generation Novasight system and on incorporating clinical user feedback from its earlier Novasight system. This focus and shift in resources continued into FY Q3 2025. For the quarter ended June 30, 2025, the Company recorded revenue of $63,000 compared to $401,000 for the same period in the prior year.

Operating expenses for the three months ended June 30, 2025, were $4.7 million, compared to $8.8 million for the same period in the prior year. The operating loss for Q3 FY 2025 was $4.6 million, compared to $8.9 million for Q3 FY 2024. This drop largely stems from a reduction in research & development expenses, which were $3.2 million in FY Q3 2025, compared to $6.3 million in the same period in FY 2024, reflecting a reduction in costs as the next-generation system nears FDA submission.

The Q3 FY 2025 net loss was $3.6 million, or $0.05 per common share, compared to a net loss of $13.0 million, or $2.12 per common share, in the three-month period ended June 30, 2024. The net loss in Q3 2025 was principally due to operating costs, partially offset by a gain in the fair value of warrant liability; the loss in Q3 FY 2024 was principally due to operating costs. In both periods, the majority of operating costs were attributable to research & development activities.

As of June 30, 2025, cash and cash equivalents were $11.3 million, up from $0.4 million as of September 30, 2024.

For detailed financial results, please refer to Conavi Medical’s filings on SEDAR+ and the Company’s website www.conavi.com.

Additional Disclosure Regarding $20M Public Offering

Further to the Company’s press release dated April 23, 2025 regarding the closing of its public equity offering for aggregate gross proceeds of $20 million (the “Offering”), the Company confirms that in connection with the Offering, it paid a cash commission of $1,034,657.75 and issued 2,408,350 compensation options to Bloom Burton Securities Inc., the sole and exclusive agent for the Offering. In addition, in connection with the Offering, 77,700 and 35,000 compensation options were issued to Raymond James Ltd. and Research Capital Corporation, respectively.

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™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid™ System has regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit conavi.com.

Cautionary Statement Regarding Forward-Looking Information

This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ System and expected FDA clearance and the commercial launch of next generation Novasight in the U.S.

These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.

Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.

Neither the TSX Venture Exchange nor its Regulation 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:
Stefano Picone
Chief Financial Officer
(416) 483-0100

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