- U.S. FDA 510(k) filing of next-generation Novasight system targeted for H2 2025 with U.S. commercial launch planned for early 2026 - Evolving medical guidelines position next-generation Novasight system as new imaging standard in interventional cardiology - Multiple non-dilutive opportunities being pursued to fund growth
TORONTO, Jan. 23, 2025 (GLOBE NEWSWIRE) --
To our Shareholders,
As we enter 2025, I’m encouraged by our recent progress and the favorable strategic landscape. Having completed our go-public transaction and raised concurrent financing of US$7.7 million, Conavi is well positioned to set a new imaging standard for the most common procedures in interventional cardiology.
The case for our Novasight platform has never been stronger. With the new European interventional cardiology guidelines strongly recommending intravascular imaging, and the expectation that similar U.S. guidelines will soon follow, we have an extraordinary opportunity in a market where 80% of procedures continue to rely on old technology. These developments come as demand is already rising, with intravascular imaging devices projected to be the fastest-growing segment of the global interventional cardiology market.1
We believe we have achieved product-market fit based on feedback and clinical experience with earlier Novasight versions at multiple hospital sites. With our capability to match the performance and pricing of single-mode systems, we believe our next-generation solution offers a truly no-compromise solution for doctors, payers, and hospital administrators.
Commercial Readiness Key opinion leaders (“KOLs”) are expected to commence system usability testing next quarter, which aims to demonstrate that we have met physician requirements and satisfied key functional specifications—validating the system’s suitability for routine clinical use. Also, in calendar Q2, we plan to continue showcasing the important clinical role to be played by hybrid imaging in coronary interventions by highlighting clinical case reports and developing a hybrid imaging whitepaper.
Our filing for U.S. FDA 510(k) clearance is targeted for the second half of 2025. Given previous clearances for earlier Novasight versions, we expect to satisfy the agency’s safety, efficacy, and quality standards. Upon clearance, we plan to begin placing systems at key U.S. hospitals on commercial terms—several have already expressed interest. Also in early 2026, in collaboration with KOLs, we plan to conduct the first-in-human study of the next-generation Novasight system. Once achieved, this will be an important milestone marking the next-generation system’s initial use in real-world clinical cases. If the results of this study are favorable, we expect they will assist us in highlighting Novasight’s safety and ease of use, and in demonstrating those clinical scenarios where hybrid imaging is particularly advantageous.
As we bring the next-generation Novasight to market, we’re working to extend our technological advantage; initiatives include further integration of AI capabilities, achieving state-of-the-art image quality for both imaging modalities, and overcoming limitations in catheterization lab workflows. Our goal is for these efforts to help support expansion beyond the US$700 million coronary (i.e., heart-based) segment to the broader interventional cardiology market, a potential US$4 billion market opportunity.
We also expect to continue to fortify our IP position, with planned patent filings covering novel methods of fabricating and assembling imaging cores and new means of improving clinical workflows.
Multiple Near-Term Revenue and Non-Dilutive Funding Opportunities We continue to explore opportunities with groups possessing significant experience in commercializing cardiovascular technologies outside of North America and China. As previously reported, our Chinese licensee recently gained regulatory approval for its coronary imaging system, triggering a fourth and final US$5.9 million milestone payment of licensing revenue to Conavi,2 highlighting the potential of other markets as global demand for interventional cardiology procedures grows.
Beyond our core business, we are also pursuing the monetization of Titan Medical’s intellectual property portfolio, acquired by Conavi as a result of the ongoing public transaction and consisting of 240 patents and patent applications. Although we cannot yet estimate the likelihood of success, we are buoyed by the rising interest in robotic surgery technology and Titan’s earlier success in licensing and selling aspects of their IP.
We continue to pursue government grants, including Ontario’s recently announced program to support scale-up for market-ready products in life sciences, with up to $2.5 million available to each successful applicant. To date, the Company has benefited from over $20 million in non-dilutive funding from government sources.
Upcoming Targeted Milestones The following targeted milestones use calendar dates:
H1 2025
Expected completion of usability and system validation with key opinion leaders
Expected publication of whitepaper and submissions to journals to drive awareness
H2 2025
Targeted timeframe for U.S. FDA 510(k) submission for the next-generation Novasight system
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 (subject to FDA clearance)
Targeted U.S. commercial launch (subject to FDA clearance)
Summary We’re planning a transformative year for Conavi, with several value-creating milestones expected to be achieved starting next quarter. As the market landscape evolves in our favor, we’re refining our technology to extend Novasight’s competitive advantage. We’re excited to be setting a new imaging standard for the most common procedures in interventional cardiology.
I am deeply grateful to our people and partners as well as the many doctors and patients who have supported us in reaching this point.
We look forward to updating you on our progress!
Sincerely,
Tom Looby CEO Conavi Medical Corp.
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”, “target”, “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 the following: Conavi’s plans for the commercialization of its Novasight Hybrid™ System, the expectation that U.S. interventional cardiology guidelines will be revised to strongly recommend intravascular imaging, the expectation that demand for intravascular imaging devices will continue to rise, Conavi’s ability match performance and pricing of single-mode systems, the commencement and successful completion of KOL testing and the outcome thereof, Conavi’s intentions to showcase the role of hybrid imaging in coronary interventions through case reports and whitepapers, Conavi’s intentions to file for U.S. FDA 510(k) clearance in respect of the next-generation Novasight system and the timing thereof, Conavi’s expectations concerning the outcome and timing of the FDA clearance process, Conavi’s plans for first-in-human studies of the next-generation Novasight system and the timing and outcome thereof, Conavi’s plans to further enhance its technological capabilities, Conavi’s intentions to expand its business beyond the coronary segment to the broader interventional cardiology market and the size of the relevant market opportunity, Conavi’s plans to fortify its IP portfolio, and Conavi’s pursuit of revenue and funding opportunities (including exploration of further international outlicensing opportunities, opportunities for monetization of Titan Medical’s intellectual property portfolio and government grant opportunities).
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 continue to finance its operations, the acceptance of the next-generation Novasight system from a clinical, commercial and regulatory perspective, 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 (which may be viewed at 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 this 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.
1 The New Interventional Cardiology Market, Diagnostic and Interventional Cardiology, Sept 12, 2023: dicardiology.com/article/new-interventional-cardiology-market (Based on data from iData reports). 2 Last month, Conavi Medical (the “Company”) announced that its exclusive licensing partner in China, East Ocean Medical (Hong Kong) Company Limited (“EOM”), had received approval by the China National Medical Products Administration for its coronary imaging system, which is based on Novasight Hybrid™ System intellectual property licensed to it by Conavi via a June 2021 technology transfer and licensing agreement. The approval triggered a fourth and final US$5.9 million milestone payment from EOM to Conavi, which the Company will use to extinguish a US$5.9 million promissory note owed by it to EOM. With this milestone achieved, the Company expects to begin benefiting from a recurring royalty revenue stream, as detailed in its press release of December 9, 2024.
