- New U.S. intracoronary imaging guidelines from the American College of Cardiology and recent peer-reviewed research strongly validate Novasight's unique value proposition
- Upsized $20 million financing led by U.S. institutional investors is expected to fund key value inflection points through planned commercial launch of next-generation Novasight Hybrid System in H1 2026
- U.S. FDA 510(k) submission remains on track for calendar Q3 2025
TORONTO, May 30, 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 common minimally invasive cardiovascular procedures, today announced its financial results for the fiscal quarter ended March 31, 2025.
"We are thrilled to have raised $20 million in financing to support finalizing product development of the next-generation Novasight Hybrid system, submit for regulatory clearance and enable commercial launch," commented Thomas Looby, CEO of Conavi Medical. "The team deserves huge credit for maintaining our timelines while working to support a significantly upsized raise in challenging market conditions. The participation of U.S. institutional investors is itself a powerful endorsement of our team, technology and strategy to set a new imaging standard for the most common procedures in interventional cardiology. Coupled with the recent upgrade in U.S. medical guidelines, we believe our timing for unlocking substantial shareholder value could not be better."
Business Highlights
All amounts in Canadian dollars unless specified otherwise:
- In January 2025, the Company completed the design freeze of the next-generation Novasight Hybrid System and initiated design verification testing in support of a regulatory application to the FDA. Activities during and after the quarter enabled Conavi to remain on track for its planned U.S. FDA 510(k) submission in calendar Q3 2025, which will build upon the previous clearance of the first generation Novasight system.
- In March 2025, new intracoronary imaging guidelines were issued by the American College of Cardiology, American Heart Association, and other leading medical organizations. Based on mounting evidence that intracoronary imaging markedly improves patient safety, these guidelines include a Class 1A recommendation (highest level of evidence) for the use of intravascular imaging in patients with acute coronary syndrome undergoing complex coronary interventions. Conavi believes these new guidelines strongly validate the clinical utility and importance of its unique hybrid IVUS (ultrasound) and OCT (optical) imaging technology, uniquely positioning the Novasight system to meet the needs of interventional cardiologists. Notably, these revised U.S. guidelines are similar to upgraded European intracoronary imaging guidelines released in August 2024.
- Also in March 2025, the Company announced that its common shares had been approved for uplisting from the OTC Pink Open Market to the OTCQB. Intended to improve investor transparency and visibility, this step is expected to increase Conavi Medical's exposure to the U.S. investment community and broaden its investor base.
- In April 2025, the Company successfully closed an upsized equity offering for aggregate gross proceeds of $20 million. Led by U.S. institutional investors, this financing is expected to provide the capital to fund Conavi's operations to the planned U.S. commercial launch of the next-generation Novasight system.
Upcoming Targeted Milestones
The following targeted milestones use calendar dates:
Q3 2025
- Targeted timeframe for U.S. FDA 510(k) submission for the next-generation Novasight system
Q4 2025
- Expected completion of usability and system validation with key opinion leaders
- Expected publication of whitepaper and case report in academic journals to drive awareness
H1 2026
- Estimated timeframe for U.S. FDA 510(k) clearance for the next-generation Novasight system
- First-in-human clinical study to highlight safety and feasibility
- Targeted U.S. commercial launch (subject to FDA clearance)
Fiscal Q2 2025 Financial Results
All amounts are in Canadian dollars unless specified otherwise:
As previously reported, in the two preceding fiscal years and in FY Q1 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 Q2 2025. For the quarter ended March 31, 2025, the Company recorded revenue of approximately $58,000 compared to approximately $589,000 for the same period in the prior year.
Operating expenses for the three months ended March 31, 2025, were approximately $5.6 million, compared to approximately $6.0 million for the same period in the prior year. The operating loss for Q2 2025 was approximately $5.4 million, compared to approximately $6.0 million for Q2 2024. This drop largely stems from a reduction in research & development expenses, which were approximately $3.8 million in FY Q2 2025, compared to approximately $4.2 million in the same period in 2024, reflecting a reduction in costs as development of the next-generation system nears completion.
The Q2 2025 net loss was approximately $3.1 million, or $0.07 per common share, compared to a net loss of approximately $7.1 million, or $1.15 per common share, in the three-month period ended March 31, 2024. The net loss in Q2 2025 was principally due to operating costs, partially offset by a gain in the fair value of warrant liability; the loss in Q2 2024 was principally due to operating costs. In both periods, the majority of operating costs were attributable to research & development activities.
As at March 31, 2025, cash and cash equivalents were approximately $1.0 million, up from approximately $0.4 million as at September 30, 2024. The FY Q2 2025 cash balance does not reflect the $20 million raised in the April 2025 public offering.
For detailed financial results, please refer to Conavi Medical's filings on SEDAR+ and the Company's website.
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 system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China's National Medical Products Administration, and Japan's Ministry of Health, Labor and Welfare. For more information, visit conavi.com.
Forward-Looking Statements
This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Conavi and its business, which may include, but are not limited to, statements with respect to the anticipated use of proceeds from the April 2025 public offering, Conavi's exposure to the U.S. investment community, the commercialization and development of the Novasight Hybrid System and the achievement and timeline of key milestones towards commercialization and development of the Novasight Hybrid System. 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" "anticipate" 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 short form prospectus dated April 15, 2025 and the joint information circular of the Company dated August 30, 2024 (both of which are on the Company's profile at sedarplus.ca). Although Conavi 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 Conavi 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
Stefano Picone
Chief Financial Officer
ir@conavi.com
(416) 483-0100
