Conavi Medical Corp. (TSXV: CNVI; OTC: 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, responded today to new
intracoronary imaging guidelines by the American College of
Cardiology, American Heart Association and other medical
organizations. The guidelines apply to patients presenting with
acute coronary syndrome (ACS) and undergoing a coronary
intervention in the left main artery or complex lesions. Notably,
the guidelines are rated Class 1A, indicating the highest level of
evidence and strongest level of recommendation.
The new guidelines offer strong validation for
Conavi as the only provider of hybrid IVUS (ultrasound) and OCT
(optical) imaging technology. As the authors explain, “both IVUS
and OCT play essential roles in evaluating the necessity for lesion
preparation, choosing the appropriate stent size, reducing the
likelihood of geographical errors, confirming proper stent
expansion, identifying complications, and determining the
underlying reasons for stent failure.”
"The updated guidelines reaffirm the critical
role of intracoronary imaging in optimizing stent procedures and
improving patient outcomes," said Dr. Megha Prasad, an
interventional cardiologist. "By leveraging the advantages of both
IVUS and OCT, we can enhance precision in stent placement, minimize
complications, and ultimately optimize care for patients with
complex coronary artery disease. Conavi’s Novasight system, as the
only hybrid IVUS-OCT device, uniquely equips physicians with both
imaging modalities in a single platform, streamlining procedures,
limiting contrast usage, and supporting more informed clinical
decisions."
“We’re highly encouraged that both IVUS and OCT
imaging are recognized as important and complementary,” commented
Thomas Looby, Conavi’s CEO. “The changes reflect the mounting
evidence of improved patient outcomes, including a 46% drop in
cardiac death1 compared to angiography alone. Our value proposition
of combining IVUS and OCT hits the bullseye for patients, doctors,
payers, and hospital administrators. Also, we believe that similar
changes in the future to other guidelines in the US covering
intracoronary procedures are likely.”
The new guidelines are available at
doi.org/10.1016/j.jacc.2024.11.009. Please see section 7.3 for “Use
of Intracoronary 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™ 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.
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 potential future changes to
clinical guidelines.
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 of the Preliminary Prospectus of the Company dated January 29,
2025 (each of 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 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.
Contacts
Stefano Picone Chief Financial Officerir@conavi.com(416)
483-0100
1 Stone GW, Intravascular imaging-guided coronary drug-eluting
stent implantation: an updated network meta-analysis, The Lancet
2024; 403: 824–3.
Conavi Medical (TSXV:CNVI)
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Conavi Medical (TSXV:CNVI)
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