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 ReadinessKey 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 OpportunitiesWe 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 MilestonesThe
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)
SummaryWe’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 LoobyCEOConavi 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.
Contact Stefano Picone Chief
Financial Officerstefano@conavi.com(416) 483-0100
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.
Conavi Medical (TSXV:CNVI)
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