Mauna Kea Technologies Announces the Publication of Positive Results of a Randomized Controlled Trial in the Field of Interstitial Lung Disease
17 Octobre 2023 - 8:00AM
Business Wire
Confocal Laser Endomicroscopy with Cellvizio
proven superior to X-ray fluoroscopy for the guidance of
transbronchial cryobiopsy, offering a ground-breaking new horizon
in Interstitial Lung Disease (ILD) diagnosis
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 publication in the peer-reviewed journal Respiration of
positive results from a large randomized controlled trial (RCT)
proving the superiority in precision and safety of Cellvizio-guided
transbronchial cryobiopsy for the diagnosis of Interstitial Lung
Disease (ILD).
In a ground-breaking study1 published online on September 27,
2023, physicians from the Respiratory Center of the Second
Affiliated Hospital of Xiamen Medical College, Xiamen, China
unveiled a significant advancement in the diagnosis of ILD through
the combined application of Confocal Laser Endomicroscopy (CLE) and
Transbronchial Cryobiopsy (TBCB).
The trial, conducted between January and November 2022, involved
80 patients with undiagnosed ILD and requiring a biopsy. The
patients were divided into two randomized groups, with one
utilizing Cellvizio and the other fluoroscopy to guide the
transbronchial cryobiopsy device. Remarkably, the CLE group
showcased a significantly higher rate of achieving a diagnosis (95%
vs. 80%), alongside a 30% reduction in operation time, a 45%
reduction in bleeding and most notably a much lower incidence of
pneumothorax (0% vs. 25%), compared to the fluoroscopy group.
“Transbronchial cryobiopsy is becoming a key tool in the
diagnosis of ILDs and a fast-growing procedure worldwide. These new
results of a large randomized controlled trial show that the use of
Cellvizio as a guidance to transbronchial cryobiopsy not only
enhances the precision of ILD diagnosis but also ensures a much
safer and more efficient procedure for patients, thus opening the
door to a new significant market opportunity for Cellvizio in
interventional pulmonology”, stated Sacha Loiseau, Ph.D., CEO
and Founder of Mauna Kea Technologies. “We are proud to witness
the transformative impact of our Cellvizio platform in advancing
the efficacy and diagnosis of Interstitial Lung Disease, a group of
diseases that affects millions of people worldwide.”
About Interstitial Lung Diseases (ILDs) Interstitial Lung
Disease (ILD) represents a diverse group of over 200 lung disorders
that primarily affect the interstitium, the tissue and space around
the air sacs in the lungs. These diseases can lead to scarring
(fibrosis) of the lungs, which can affect a person's ability to
breathe and get enough oxygen into the bloodstream. The symptoms
often include dry cough and shortness of breath that can be
accompanied by fatigue and weight loss. In 2019, there were an
estimated 654,841 cases of ILDs in the USA, leading to 21,505
deaths2. The crude prevalence per 100,000 was 179.7 in males and
218.9 in females. While the exact cause of many types of ILD
remains unknown, some can be linked to prolonged exposure to
harmful substances, autoimmune diseases, or certain medications.
Early diagnosis and tailored treatment are crucial to managing the
disease and improving the quality of life for those affected.
About Transbronchial Cryobiopsy (TBCB) Transbronchial
cryobiopsy is a newer diagnostic procedure used to obtain lung
tissue samples for the diagnosis of various lung diseases,
especially interstitial lung diseases. Unlike the conventional
transbronchial biopsy, which uses forceps, the cryobiopsy utilizes
a probe cooled by cryogenic gases to freeze and extract a larger
and more intact tissue sample from the lungs. This can provide a
more accurate diagnosis, as the obtained samples are generally of
better quality and larger size than those from traditional
methods.
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 Techonologies' 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
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1 Cuiyun Zuo, Keying Xue, Hui Yang, Rui Huang, Zhiya Yong,
Meihua Zhang, Yanli Lin, Xiaoqin Tian, Yingying Gu, Mingyao Ke;
Clinical Application of Confocal Laser Endomicroscopy Combined with
Cryobiopsy in the Diagnosis of Interstitial Lung Disease.
Respiration 2023; https://doi.org/10.1159/000533868
2 The prevalence and burden of interstitial lung diseases in the
USA
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8819246/#:~:text=In%202019%2C%20in%20the%20USA,in%20females%20(table%201)
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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
Mauna Kea Technologies (EU:ALMKT)
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