Mauna Kea Technologies Announces First Patient Enrolled in the Pivotal CLEVER Clinical Trial in Peripheral Lung Cancer
02 Noviembre 2023 - 1:00AM
Business Wire
Ongoing enrollment of over 200 patients
across 7 sites in Europe and the U.S.
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor
of Cellvizio®, the multidisciplinary probe and needle-based
confocal laser endomicroscopy (p/nCLE) platform, today announces
the first patient enrollment in the multi-center randomized
controlled trial (RCT) entitled "Confocal Laser Endomicroscopy
VERification” (CLEVER, NCT06079970)1 in collaboration with the
Amsterdam University Medical Centers (UMC) for the diagnosis and
management of peripheral lung lesions. In the framework of this
trial, over 200 patients will be enrolled across 7 sites in Europe
and the U.S. until end of Q2 2025.
Lung cancer is the world’s leading cause of cancer deaths
claiming over 1.8 million lives every year - more than colorectal,
breast, and prostate cancers combined. The rise in lung cancer
screening and the increased use of chest-computed tomography (CT)
has generated a surge in the detection of suspected malignant lung
lesions globally, increasing the need for more effective and
efficient diagnostic methods. Over 80% of these incidental lesions
develop in the peripheral bronchi and are not easily visualized or
accessed during conventional bronchoscopy. Adding nCLE as an
adjunctive technique offers a potential solution by providing
real-time feedback on the correct positioning of biopsy tweezers or
needles (tool-in-lesion) and collecting the right cells samples
(lesion-in-tool).
Jouke T. Annema, M.D., Ph.D., Professor of Pulmonary
Endoscopy, declared: "Over the past few years, we have
established solid foundations for the use of nCLE as an important
tool in the armamentarium of the interventional pulmonologist. With
this new randomized controlled trial involving some of the best
interventional pulmonologists in Europe and in the U.S., we aim at
confirming in a definitive way that the addition of needle-based
Confocal Laser Endomicroscopy to bronchoscopy enhances the
diagnostic yield for peripheral lung lesions, while also improving
the clinical workflow.”
Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea
Technologies, commented: "Diagnosing peripheral pulmonary
nodules is a critical step in effectively treating lung cancer
patients, but current tools often don’t measure up. This
collaboration with Amsterdam UMC is another exciting opportunity to
evaluate and quantify Cellvizio's superior diagnostic capabilities.
As we push forward with this study, our aim is not only to
underscore Cellvizio's advantages but also to increase our value
proposition for potential strategic partnerships.”
About Mauna Kea Technologies Mauna Kea Technologies is a
global medical device company that manufactures and sells
Cellvizio®, the real-time in vivo cellular imaging platform. This
technology uniquely delivers in vivo cellular visualization which
enables physicians to monitor the progression of disease over time,
assess point-in-time reactions as they happen in real time,
classify indeterminate areas of concern, and guide surgical
interventions. The Cellvizio® platform is used globally across a
wide range of medical specialties and is making a transformative
change in the way physicians diagnose and treat patients. For more
information, visit www.maunakeatech.com.
Disclaimer This press release contains forward-looking
statements about Mauna Kea Technologies and its business. All
statements other than statements of historical fact included in
this press release, including, but not limited to, statements
regarding Mauna Kea Technologies' financial condition, business,
strategies, plans and objectives for future operations are
forward-looking statements. Mauna Kea Technologies believes that
these forward-looking statements are based on reasonable
assumptions. However, no assurance can be given that the
expectations expressed in these forward-looking statements will be
achieved. These forward-looking statements are subject to numerous
risks and uncertainties, including those described in Chapter 3 of
Mauna Kea Technologies' 2022 Universal Registration Document filed
with the Autorité des marchés financiers (AMF) on June 28, 2023
under number D-23-0545, which is available on the Company's website
(www.maunakeatech.fr), as well as the risks associated with changes
in economic conditions, financial markets and the markets in which
Mauna Kea Technologies operates. The forward-looking statements
contained in this press release are also subject to risks that are
unknown to Mauna Kea Technologies or that Mauna Kea Technologies
does not currently consider material. The occurrence of some or all
of these risks could cause the actual results, financial condition,
performance or achievements of Mauna Kea Technologies to differ
materially from those expressed in the forward-looking statements.
This press release and the information contained herein do not
constitute an offer to sell or subscribe for, or the solicitation
of an order to buy or subscribe for, shares of Mauna Kea
Technologies in any jurisdiction in which such offer, solicitation
or sale would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. The
distribution of this press release may be restricted in certain
jurisdictions by local law. Persons into whose possession this
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applicable to this document.
___________________________ 1
https://clinicaltrials.gov/study/NCT06079970, “Confocal Laser
Endomicroscopy VERification (CLEVER)”, October 12, 2023
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Mauna Kea Technologies - Investor Relations
investors@maunakeatech.com
NewCap - Investor Relations Aurélie Manavarere / Thomas
Grojean +33 (0)1 44 71 94 94 maunakea@newcap.eu
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